A Phase 2 interventional study of Placebo and Bimekizumab in Psoriatic Arthritis, sponsored by UCB Biopharma S.P.R.L.. Completed at 40 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 2, Interventional, and Treatment
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's enrollment of 206 is above the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
Exclusion Criteria:
Subjects with concurrent or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Other: Placebo
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Drug: Bimekizumab
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Drug: Bimekizumab
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Drug: Bimekizumab
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Also known as: UCB4940
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Time frame: Week 12
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time frame: Week 12
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time frame: Week 12
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
Percentage of Participants With at Least One Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Time frame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Time frame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Changes From Baseline in Body Weight During the Study
Body weight was measured in kilograms.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
Time frame: Baseline, Week 12 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10\^9/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Platelets was measured in number of platelets per liter (10\^9/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Albumin was measured in grams per liter (g/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Urea nitrogen was measured in millimoles per liter (mmol/L).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Hyaline casts was measured in cells per low power field (cells/LPF).
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Urine pH was measured on a pH scale.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
The study started to enroll patients in October 2016 and concluded in July 2018.
| Milestone | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Placebo - BKZ 160 mg | Placebo - BZK 320 mg | BKZ 16 mg - BKZ 160 mg | BZK 16 mg - BZK 320 mg | BZK 160 mg LD - BZK 160 mg | BZK 160 mg - BKZ Dose 160 mg | BKZ 320 mg - BKZ 320 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 42 | 41 | 41 | 41 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed double-blind period | 42 | 41 | 40 | 39 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed wk12 and started dose-blind | 40 | 41 | 40 | 37 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 40 | 41 | 40 | 37 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Low egfr | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study medication discontinued prior wk12 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Placebo - BKZ 160 mg | Placebo - BZK 320 mg | BKZ 16 mg - BKZ 160 mg | BZK 16 mg - BZK 320 mg | BZK 160 mg LD - BZK 160 mg | BZK 160 mg - BKZ Dose 160 mg | BKZ 320 mg - BKZ 320 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 20 | 20 | 22 | 19 | 37 | 40 | 41 |
| Completed | 0 | 0 | 0 | 0 | 0 | 20 | 18 | 22 | 18 | 34 | 38 | 39 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 3 | 2 | 2 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 0 |
| Withdrew: Non-cooperating patient | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrew before safety follow-up visit | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
| percentage of subjects | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 160 mg (FAS) | BKZ 160 mg LD (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | 7.1 | 26.8 | 41.5 | 46.3 | 24.4 |
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
| percentage of subjects | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 160 mg (FAS) | BKZ 160 mg LD (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | 19.0 | 53.7 | 73.2 | 61.0 | 51.2 |
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: * TJC based on 78 joints * SJC based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by PGADA * Disease activity as assessed by PhGADA * Pain as assessed by PtAAP * Physical function as assessed by HAQ-DI * Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
| percentage of subjects | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 160 mg (FAS) | BKZ 160 mg LD (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | 4.8 | 12.2 | 19.5 | 31.7 | 14.6 |
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
| percentage of subjects | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 160 mg (FAS) | BKZ 160 mg LD (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 10.0 | 35.7 | 62.5 | 52.9 | 45.5 |
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
| percentage of subjects | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 160 mg (FAS) | BKZ 160 mg LD (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 10.0 | 57.1 | 68.8 | 70.6 | 72.7 |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
| percentage of participants | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | BKZ 320 mg (SS) - up to Wk 68 |
|---|---|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | 57.1 | 33.33 | 74.6 | 72.5 |
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
| percentage of participants | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | BKZ 320 mg (SS) - up to Wk 68 |
|---|---|---|---|---|
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 2.4 | 0 | 6.3 | 0 |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
| percentage of participants | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | BKZ 320 mg (SS) - up to Wk 68 |
|---|---|---|---|---|
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 4.8 | 0 | 4.8 | 2.5 |
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
| mmHg | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Diastolic Blood Pressure 30 min post dose | 1.3 ± 8.9 | -1.2 ± 4.9 | -1.2 ± 5.4 | 0.6 ± 6.1 | -0.6 ± 5.3 |
| Diastolic Blood Pressure 1 h post dose | 1.1 ± 8.8 | -2.0 ± 6.3 | -0.7 ± 8.1 | 1.2 ± 6.7 | -1.0 ± 5.5 |
| Diastolic Blood Pressure Week 1 | 0.1 ± 9.6 | -0.3 ± 6.5 | 0.6 ± 11.4 | -0.9 ± 6.6 | -0.4 ± 6.5 |
| Diastolic Blood Pressure Week 2 | 0.7 ± 10.4 | -0.7 ± 6.5 | -1.0 ± 8.9 | -2.7 ± 8.3 | -0.1 ± 9.0 |
| Diastolic Blood Pressure Week 4 pre-dose | 0.0 ± 8.2 | -1.7 ± 8.4 | -1.4 ± 10.7 | -0.8 ± 7.8 | -1.3 ± 7.4 |
| Diastolic Blood Pressure Week 4 post dose | -2.0 ± 8.7 | -1.0 ± 7.3 | -1.2 ± 8.9 | -0.9 ± 8.3 | -1.6 ± 7.6 |
| Diastolic Blood Pressure Week 8 pre-dose | 1.0 ± 8.2 | -1.3 ± 8.7 | 0.3 ± 8.7 | -0.5 ± 7.0 | 0.2 ± 6.9 |
| Diastolic Blood Pressure Week 8 post dose | -0.9 ± 9.1 | -1.1 ± 8.4 | 0.6 ± 8.7 | -0.7 ± 7.3 | -2.2 ± 7.4 |
| Diastolic Blood Pressure Week 12 pre-dose | 0.2 ± 9.1 | -1.1 ± 10.4 | 0.2 ± 8.5 | -1.5 ± 7.9 | -0.6 ± 8.2 |
| Diastolic Blood Pressure Week 12 post dose | -0.3 ± 9.6 | -2.0 ± 10.0 | 0.3 ± 8.3 | -1.8 ± 7.9 | -2.6 ± 8.0 |
| Diastolic Blood Pressure Week 16 pre-dose | -2.7 ± 9.6 | -3.5 ± 8.9 | -0.8 ± 8.6 | -1.2 ± 8.7 | -0.4 ± 7.9 |
| Diastolic Blood Pressure Week 16 post dose | -3.0 ± 9.1 | -1.9 ± 8.3 | -1.7 ± 9.2 | -1.1 ± 7.9 | -2.4 ± 8.7 |
| Diastolic Blood Pressure Week 20 pre-dose | 0.5 ± 10.3 | -1.8 ± 9.0 | -0.6 ± 8.3 | -1.4 ± 8.3 | -1.8 ± 7.3 |
| Diastolic Blood Pressure Week 20 post dose | 0.1 ± 9.5 | -3.1 ± 8.3 | -0.4 ± 9.2 | -3.0 ± 9.3 | -2.6 ± 7.1 |
| Diastolic Blood Pressure Week 24 pre-dose | -0.4 ± 7.6 | -1.6 ± 7.2 | -0.7 ± 9.3 | 1.0 ± 6.9 | -1.0 ± 6.6 |
| Diastolic Blood Pressure Week 24 post dose | -0.6 ± 7.5 | -1.7 ± 7.9 | -0.3 ± 8.2 | -0.3 ± 7.6 | -1.4 ± 7.9 |
| Diastolic Blood Pressure Week 28 pre-dose | 1.4 ± 7.9 | -0.6 ± 9.7 | 0.9 ± 9.5 | -0.6 ± 6.9 | -0.5 ± 7.5 |
| Diastolic Blood Pressure Week 28 post dose | 1.2 ± 8.7 | -2.0 ± 9.4 | 1.2 ± 9.0 | -0.2 ± 7.1 | -1.8 ± 7.1 |
| Diastolic Blood Pressure Week 32 pre-dose | 0.2 ± 8.5 | -1.7 ± 8.6 | 1.6 ± 9.2 | -0.3 ± 9.3 | -1.2 ± 8.6 |
| Diastolic Blood Pressure Week 32 post dose | 0.7 ± 10.0 | -3.0 ± 8.6 | 0.1 ± 9.6 | -0.6 ± 8.5 | -2.1 ± 8.5 |
| Diastolic Blood Pressure Week 36 pre-dose | 0.0 ± 8.6 | -0.6 ± 9.2 | 1.4 ± 8.9 | -0.9 ± 7.2 | 0.8 ± 7.5 |
| Diastolic Blood Pressure Week 36 post dose | 1.6 ± 7.7 | -1.6 ± 9.2 | 1.3 ± 9.3 | -1.7 ± 6.8 | -0.1 ± 7.1 |
| Diastolic Blood Pressure Week 40 pre-dose | 0.8 ± 7.6 | -2.5 ± 9.7 | 1.0 ± 9.5 | -1.0 ± 7.2 | -1.9 ± 6.8 |
| Diastolic Blood Pressure Week 40 post dose | 0.9 ± 7.7 | -1.8 ± 9.1 | 0.2 ± 8.3 | -0.8 ± 6.6 | -0.1 ± 7.3 |
| Diastolic Blood Pressure Week 44 pre-dose | 1.4 ± 9.3 | -2.1 ± 7.7 | 1.3 ± 9.2 | -0.4 ± 6.7 | -2.4 ± 10.9 |
| Diastolic Blood Pressure Week 44 post dose | 2.3 ± 9.2 | -1.3 ± 7.6 | -0.7 ± 8.7 | -1.4 ± 8.1 | -1.5 ± 6.5 |
| Diastolic Blood Pressure Week 48 | 1.8 ± 9.2 | 0.4 ± 9.7 | 1.1 ± 9.1 | 0.6 ± 8.7 | -0.8 ± 6.4 |
| Systolic Blood Pressure 30 min post dose | 0.8 ± 8.1 | 0.5 ± 9.7 | -0.8 ± 8.2 | 1.5 ± 8.8 | -2.5 ± 9.7 |
| Systolic Blood Pressure 1 hour post dose | -0.6 ± 9.4 | -2.0 ± 10.5 | 0.2 ± 8.7 | 1.0 ± 8.4 | -1.8 ± 7.1 |
| Systolic Blood Pressure Week 1 | -1.7 ± 10.8 | -1.3 ± 10.0 | 1.7 ± 12.9 | -2.4 ± 8.3 | -1.6 ± 11.0 |
| Systolic Blood Pressure Week 2 | -0.7 ± 12.9 | -0.2 ± 9.8 | -0.1 ± 13.2 | -2.7 ± 8.2 | -0.4 ± 11.9 |
| Systolic Blood Pressure Week 4 pre-dose | -2.6 ± 11.4 | -1.5 ± 10.6 | -1.0 ± 13.0 | -2.3 ± 10.5 | -2.7 ± 11.2 |
| Systolic Blood Pressure Week 4 post dose | -3.5 ± 12.1 | -0.6 ± 10.4 | -2.2 ± 11.8 | -0.6 ± 9.1 | -3.7 ± 11.3 |
| Systolic Blood Pressure Week 8 pre-dose | -2.1 ± 13.1 | -0.8 ± 10.7 | -1.1 ± 11.3 | -3.6 ± 11.7 | -1.3 ± 10.4 |
| Systolic Blood Pressure Week 8 post dose | -3.2 ± 12.6 | -1.9 ± 11.6 | -0.3 ± 11.1 | -2.8 ± 10.2 | -1.9 ± 12.0 |
| Systolic Blood Pressure Week 12 pre-dose | -3.3 ± 12.4 | 1.6 ± 13.7 | -3.1 ± 11.7 | -4.4 ± 10.8 | -2.6 ± 9.7 |
| Systolic Blood Pressure Week 12 post dose | -3.9 ± 14.1 | 2.1 ± 11.1 | -1.9 ± 12.0 | -3.6 ± 10.1 | -2.4 ± 10.1 |
| Systolic Blood Pressure Week 16 pre-dose | -3.6 ± 15.1 | -2.3 ± 12.3 | -4.3 ± 11.3 | -4.3 ± 12.5 | -2.3 ± 11.4 |
| Systolic Blood Pressure Week 16 post dose | -3.7 ± 17.1 | -2.6 ± 11.7 | -3.4 ± 12.7 | -2.7 ± 11.0 | -5.7 ± 8.5 |
| Systolic Blood Pressure Week 20 pre-dose | -2.0 ± 13.1 | -3.2 ± 12.5 | -2.6 ± 11.9 | -5.4 ± 9.7 | -4.5 ± 10.5 |
| Systolic Blood Pressure Week 20 post dose | -1.9 ± 14.5 | -3.2 ± 13.0 | -3.7 ± 12.2 | -7.9 ± 11.9 | -4.4 ± 9.9 |
| Systolic Blood Pressure Week 24 pre-dose | -3.1 ± 10.5 | -1.1 ± 9.5 | -2.7 ± 12.3 | -3.6 ± 10.1 | -0.3 ± 10.5 |
| Systolic Blood Pressure Week 24 post dose | -2.6 ± 10.9 | -2.8 ± 10.5 | -2.2 ± 11.7 | -3.0 ± 9.7 | -1.1 ± 10.5 |
| Systolic Blood Pressure Week 28 pre-dose | -0.1 ± 11.4 | -2.5 ± 12.8 | -2.5 ± 13.1 | 0.4 ± 11.6 | -2.9 ± 11.3 |
| Systolic Blood Pressure Week 28 post dose | -1.1 ± 12.1 | -2.9 ± 11.1 | -2.6 ± 12.4 | -0.7 ± 11.9 | -4.6 ± 11.2 |
| Systolic Blood Pressure Week 32 pre-dose | -0.9 ± 13.1 | -1.5 ± 13.3 | -0.6 ± 12.4 | 0.6 ± 11.0 | -3.7 ± 12.4 |
| Systolic Blood Pressure Week 32 post dose | -1.7 ± 12.6 | -2.2 ± 11.6 | 0.3 ± 12.5 | -0.4 ± 11.1 | -4.8 ± 10.6 |
| Systolic Blood Pressure Week 36 pre-dose | -3.1 ± 11.9 | 1.1 ± 13.9 | -0.2 ± 13.6 | -1.8 ± 11.2 | -3.2 ± 11.1 |
| Systolic Blood Pressure Week 36 post dose | -0.6 ± 11.1 | 1.3 ± 12.6 | -0.5 ± 12.4 | -3.8 ± 10.8 | -3.8 ± 11.4 |
| Systolic Blood Pressure Week 40 pre-dose | -3.3 ± 12.1 | -3.1 ± 11.4 | -1.6 ± 12.9 | -4.0 ± 9.5 | -1.2 ± 11.0 |
| Systolic Blood Pressure Week 40 post dose | -2.3 ± 11.7 | -0.4 ± 12.7 | -1.2 ± 13.8 | -3.2 ± 11.6 | -2.2 ± 9.6 |
| Systolic Blood Pressure Week 44 pre-dose | -2.8 ± 12.3 | -2.8 ± 9.9 | 0.0 ± 13.1 | -5.1 ± 9.9 | -3.9 ± 10.3 |
| Systolic Blood Pressure Week 44 post dose | -1.8 ± 14.5 | -1.2 ± 9.5 | -0.6 ± 10.4 | -4.6 ± 10.3 | -3.8 ± 10.5 |
| Systolic Blood Pressure Week 48 | -1.1 ± 14.0 | -0.1 ± 12.5 | -0.1 ± 12.6 | -2.8 ± 11.5 | -5.2 ± 9.6 |
Pulse rate was measured in beats per minute (beats/min).
| beats/min | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| 30 min post dose | 0.4 ± 5.4 | -0.8 ± 5.6 | -1.5 ± 7.2 | -2.3 ± 7.5 | -1.1 ± 7.2 |
| 1 hour post dose | 0.3 ± 6.7 | 1.0 ± 11.3 | -0.8 ± 7.6 | -0.8 ± 8.1 | -0.4 ± 7.0 |
| Week 1 | 2.9 ± 8.3 | -1.5 ± 7.5 | -0.7 ± 7.1 | 0.6 ± 8.9 | -0.8 ± 9.0 |
| Week 2 | 1.2 ± 6.4 | -1.7 ± 5.7 | -0.7 ± 7.9 | -1.0 ± 9.1 | -0.4 ± 6.9 |
| Week 4 pre-dose | -0.2 ± 5.3 | -2.1 ± 6.9 | -1.9 ± 8.1 | 0.1 ± 9.8 | -1.0 ± 6.6 |
| Week 4 post dose | 0.4 ± 8.6 | -2.6 ± 6.6 | -2.7 ± 9.5 | -0.5 ± 9.4 | -1.1 ± 6.2 |
| Week 8 pre-dose | 0.9 ± 6.5 | -0.6 ± 8.0 | -1.6 ± 8.6 | 0.8 ± 6.9 | -1.3 ± 8.2 |
| Week 8 post dose | -0.1 ± 6.9 | -1.3 ± 8.6 | -1.9 ± 8.6 | 0.0 ± 8.5 | -2.3 ± 8.3 |
| Week 12 pre-dose | 1.1 ± 10.2 | -2.2 ± 8.5 | -2.9 ± 10.5 | -1.7 ± 9.5 | -1.1 ± 8.4 |
| Week 12 post dose | -0.6 ± 8.8 | -3.3 ± 8.8 | -3.6 ± 9.4 | -2.1 ± 9.7 | -2.0 ± 7.8 |
| Week 16 pre-dose | -0.2 ± 8.5 | -2.1 ± 5.8 | -2.9 ± 8.0 | -1.9 ± 10.1 | -1.3 ± 7.2 |
| Week 16 post dose | -0.1 ± 9.9 | -3.5 ± 5.5 | -3.7 ± 9.7 | -2.1 ± 9.8 | -2.2 ± 7.3 |
| Week 20 pre-dose | -0.1 ± 10.3 | -2.4 ± 7.0 | -1.7 ± 10.3 | 0.0 ± 9.0 | -1.2 ± 9.0 |
| Week 20 post dose | -0.7 ± 6.8 | -2.3 ± 7.8 | -2.1 ± 9.7 | -0.1 ± 8.5 | -1.3 ± 8.9 |
| Week 24 pre-dose | -0.5 ± 7.9 | -2.0 ± 8.1 | -2.8 ± 10.4 | -0.7 ± 7.3 | -1.2 ± 7.8 |
| Week 24 post dose | -0.9 ± 7.8 | -2.9 ± 8.5 | -3.0 ± 9.6 | -1.3 ± 6.9 | -2.5 ± 7.1 |
| Week 28 pre-dose | 1.9 ± 9.7 | -2.1 ± 10.0 | 0.0 ± 9.3 | -0.5 ± 11.2 | 0.2 ± 8.3 |
| Week 28 post dose | 1.8 ± 7.5 | -3.0 ± 9.4 | -0.5 ± 8.5 | -0.8 ± 10.0 | 0.0 ± 7.5 |
| Week 32 pre-dose | 3.3 ± 10.0 | -0.9 ± 7.9 | -2.0 ± 9.2 | -1.2 ± 10.6 | -0.3 ± 7.8 |
| Week 32 post dose | 3.3 ± 8.4 | -0.8 ± 7.8 | -3.0 ± 9.5 | -1.9 ± 9.6 | -2.0 ± 8.8 |
| Week 36 pre-dose | 0.7 ± 8.5 | 0.2 ± 7.5 | -2.6 ± 8.6 | -2.6 ± 10.2 | -0.5 ± 9.7 |
| Week 36 post dose | 1.1 ± 7.6 | -0.8 ± 8.2 | -3.0 ± 9.8 | -2.5 ± 8.2 | -1.4 ± 9.6 |
| Week 40 pre-dose | 2.7 ± 10.3 | -0.5 ± 8.8 | 1.0 ± 10.1 | -1.7 ± 7.6 | 2.0 ± 9.4 |
| Week 40 post dose | 0.9 ± 8.3 | -1.7 ± 8.3 | 0.0 ± 8.9 | -2.0 ± 8.4 | 0.5 ± 9.1 |
| Week 44 pre-dose | 2.2 ± 8.9 | -1.6 ± 6.9 | -0.4 ± 10.1 | -1.4 ± 8.2 | 0.7 ± 9.7 |
| Week 44 post dose | 2.9 ± 6.9 | -1.7 ± 8.0 | -0.5 ± 11.0 | -2.8 ± 7.7 | -0.2 ± 10.3 |
| Week 48 | 2.0 ± 8.9 | -3.7 ± 7.8 | -2.5 ± 10.4 | -4.2 ± 9.5 | -3.1 ± 9.5 |
Body weight was measured in kilograms.
| kilograms | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 12 | 0.14 ± 3.38 | -0.87 ± 3.12 | 0.21 ± 1.78 | -0.38 ± 1.80 | -0.04 ± 2.39 |
| Week 24 | 0.33 ± 4.10 | -0.03 ± 3.48 | -0.07 ± 2.63 | -0.13 ± 2.37 | -0.39 ± 3.73 |
| Week 36 | 0.32 ± 5.15 | -0.14 ± 2.90 | 0.27 ± 3.42 | 0.15 ± 2.36 | -0.04 ± 4.19 |
| Week 48 | 0.21 ± 4.42 | 0.45 ± 3.41 | 0.80 ± 3.84 | -0.14 ± 3.32 | 0.11 ± 4.24 |
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
| msec | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| QTcB Week 12 | 3.4 ± 32.7 | -2.8 ± 29.9 | -5.6 ± 41.8 | 1.5 ± 18.2 | -1.9 ± 31.4 |
| QTcB Week 48 | -2.5 ± 34.8 | -5.8 ± 36.5 | -5.9 ± 22.2 | -4.7 ± 21.0 | -5.7 ± 27.7 |
| QTcF Week 12 | 4.5 ± 27.5 | -2.5 ± 22.4 | -2.2 ± 14.2 | -0.5 ± 17.0 | -3.0 ± 18.8 |
| QTcF Week 48 | -0.1 ± 30.7 | -6.1 ± 31.4 | -0.2 ± 15.6 | -2.2 ± 20.0 | 4.6 ± 44.6 |
| PR Week 12 | -1.7 ± 23.3 | -1.0 ± 23.7 | -19.6 ± 102.1 | 3.2 ± 18.2 | -9.5 ± 32.3 |
| PR Week 48 | 2.6 ± 33.7 | 17.5 ± 128.8 | 4.0 ± 163.0 | 0.8 ± 18.9 | -2.8 ± 26.5 |
| QRS Week 12 | 2.6 ± 22.3 | -2.9 ± 10.8 | -1.8 ± 7.6 | -0.2 ± 5.4 | 6.1 ± 42.8 |
| QRS Week 48 | 5.6 ± 21.4 | -1.5 ± 16.1 | -4.0 ± 13.0 | 0.6 ± 16.2 | 0.1 ± 18.7 |
| QT Week 12 | -2.0 ± 46.6 | 1.7 ± 34.0 | 9.5 ± 21.4 | 3.8 ± 25.6 | 11.5 ± 80.8 |
| QT Week 48 | -0.7 ± 33.4 | 3.1 ± 29.9 | 3.9 ± 22.8 | 5.4 ± 26.7 | 0.7 ± 31.6 |
| RR Week 12 | 3.3 ± 99.3 | -22.5 ± 212.6 | 75.8 ± 179.3 | 11.0 ± 125.1 | -17.0 ± 182.1 |
| RR Week 48 | -0.6 ± 116.1 | 11.9 ± 187.1 | 65.2 ± 139.0 | 44.3 ± 124.0 | 25.1 ± 148.5 |
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10\^9/L).
| 10^9 white blood cells per liter | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Basophils Week 1 | 0.000 ± 0.0387 | 0.000 ± 0.0329 | -0.002 ± 0.0408 | 0.007 ± 0.0264 | 0.008 ± 0.0350 |
| Basophils Week 2 | 0.002 ± 0.0269 | 0.003 ± 0.0283 | 0.000 ± 0.0488 | 0.000 ± 0.0316 | 0.005 ± 0.0384 |
| Basophils Week 4 | 0.002 ± 0.0474 | 0.005 ± 0.0324 | -0.007 ± 0.0463 | 0.005 ± 0.0312 | 0.005 ± 0.0312 |
| Basophils Week 8 | -0.002 ± 0.0353 | 0.000 ± 0.0229 | -0.005 ± 0.0384 | 0.003 ± 0.0367 | 0.002 ± 0.0418 |
| Basophils Week 12 | 0.002 ± 0.0353 | 0.003 ± 0.0280 | -0.002 ± 0.0462 | 0.000 ± 0.0329 | 0.010 ± 0.0374 |
| Basophils Week 16 | 0.010 ± 0.0431 | 0.005 ± 0.0324 | -0.007 ± 0.0463 | 0.000 ± 0.0329 | 0.008 ± 0.0417 |
| Basophils Week 20 | -0.003 ± 0.0362 | 0.003 ± 0.0362 | 0.000 ± 0.0500 | 0.005 ± 0.0329 | 0.000 ± 0.0397 |
| Basophils Week 24 | 0.000 ± 0.0397 | 0.005 ± 0.0324 | -0.003 ± 0.0530 | 0.008 ± 0.0368 | 0.005 ± 0.0389 |
| Basophils Week 28 | 0.005 ± 0.0394 | 0.000 ± 0.0329 | 0.008 ± 0.0526 | 0.011 ± 0.0323 | 0.005 ± 0.0450 |
| Basophils Week 32 | 0.000 ± 0.0324 | 0.005 ± 0.0320 | -0.010 ± 0.0441 | 0.009 ± 0.0379 | 0.010 ± 0.0384 |
| Basophils Week 36 | 0.000 ± 0.0408 | 0.003 ± 0.0283 | -0.002 ± 0.0474 | 0.012 ± 0.0415 | 0.013 ± 0.0409 |
| Basophils Week 40 | 0.003 ± 0.0506 | 0.005 ± 0.0399 | -0.010 ± 0.0379 | 0.006 ± 0.0343 | 0.000 ± 0.0403 |
| Basophils Week 44 | 0.006 ± 0.0410 | 0.003 ± 0.0372 | 0.000 ± 0.0387 | 0.006 ± 0.0422 | 0.000 ± 0.0338 |
| Basophils Week 48 | -0.005 ± 0.0462 | 0.003 ± 0.291 | -0.010 ± 0.0441 | 0.006 ± 0.0354 | 0.000 ± 0.0324 |
| Eosinophils Week 1 | 0.010 ± 0.0860 | 0.016 ± 0.0718 | -0.002 ± 0.0801 | -0.005 ± 0.0999 | 0.017 ± 0.0636 |
| Eosinophils Week 2 | 0.005 ± 0.0731 | 0.013 ± 0.0777 | 0.002 ± 0.0913 | 0.002 ± 0.0880 | 0.029 ± 0.0929 |
| Eosinophils Week 4 | 0.002 ± 0.0987 | 0.016 ± 0.0594 | 0.002 ± 0.0780 | 0.005 ± 0.0999 | 0.027 ± 0.0895 |
| Eosinophils Week 8 | 0.024 ± 0.0969 | -0.003 ± 0.0707 | 0.000 ± 0.1000 | 0.008 ± 0.0941 | 0.005 ± 0.0669 |
| Eosinophils Week 12 | 0.020 ± 0.0954 | 0.010 ± 0.0882 | 0.002 ± 0.0831 | -0.026 ± 0.1155 | 0.017 ± 0.0704 |
| Eosinophils Week 16 | 0.045 ± 0.1253 | 0.021 ± 0.0935 | 0.010 ± 0.0759 | -0.005 ± 0.1559 | 0.033 ± 0.0829 |
| Eosinophils Week 20 | 0.036 ± 0.1038 | 0.026 ± 0.1186 | 0.024 ± 0.1157 | -0.014 ± 0.1228 | 0.038 ± 0.0935 |
| Eosinophils Week 24 | 0.031 ± 0.1301 | 0.013 ± 0.0844 | 0.058 ± 0.2111 | -0.019 ± 0.1238 | 0.037 ± 0.1192 |
| Eosinophils Week 28 | 0.036 ± 0.0986 | 0.018 ± 0.0926 | 0.053 ± 0.1826 | -0.000 ± 0.1213 | 0.025 ± 0.0870 |
| Eosinophils Week 32 | 0.049 ± 0.1502 | 0.033 ± 0.0838 | 0.020 ± 0.1418 | 0.024 ± 0.1577 | 0.041 ± 0.1141 |
| Eosinophils Week 36 | 0.054 ± 0.1726 | 0.018 ± 0.0955 | 0.022 ± 0.0909 | 0.027 ± 0.1526 | 0.015 ± 0.0961 |
| Eosinophils Week 40 | 0.050 ± 0.1444 | 0.018 ± 0.0865 | 0.018 ± 0.0958 | 0.015 ± 0.1971 | 0.039 ± 0.1128 |
| Eosinophils Week 44 | 0.072 ± 0.1523 | 0.019 ± 0.0908 | 0.024 ± 0.0994 | -0.009 ± 0.1798 | 0.006 ± 0.0893 |
| Eosinophils Week 48 | 0.045 ± 0.1811 | 0.006 ± 0.0754 | 0.023 ± 0.0891 | 0.009 ± 0.2833 | -0.005 ± 0.0857 |
| Leukocytes Week 1 | -0.271 ± 1.1885 | -0.597 ± 1.1490 | -0.656 ± 1.2593 | -1.029 ± 1.6496 | -0.285 ± 1.6896 |
| Leukocytes Week 2 | 0.157 ± 1.3195 | -0.131 ± 2.1769 | -0.309 ± 1.3735 | -0.954 ± 2.0441 | -0.322 ± 1.5501 |
| Leukocytes Week 4 | -0.049 ± 1.1938 | -0.411 ± 1.1988 | -0.336 ± 1.5088 | -1.017 ± 1.9397 | -0.656 ± 1.4264 |
| Leukocytes Week 8 | 0.429 ± 1.7036 | -0.333 ± 1.4014 | -0.185 ± 1.2889 | -1.071 ± 1.9639 | -0.629 ± 1.5489 |
| Leukocytes Week 12 | 0.190 ± 1.6223 | -0.438 ± 1.3854 | -0.495 ± 1.6904 | -0.997 ± 2.1806 | -0.634 ± 1.6084 |
| Leukocytes Week 16 | -0.400 ± 1.5616 | -0.839 ± 1.8179 | -0.590 ± 1.4668 | -1.318 ± 2.3324 | -0.293 ± 1.8427 |
| Leukocytes Week 20 | -0.936 ± 1.2756 | -1.100 ± 1.5599 | -0.432 ± 1.3032 | -0.932 ± 2.2832 | -0.455 ± 1.7116 |
| Leukocytes Week 24 | -1.251 ± 1.3888 | -0.884 ± 1.7768 | -0.495 ± 1.4216 | -1.119 ± 2.2807 | -0.765 ± 1.8691 |
| Leukocytes Week 28 | -0.700 ± 1.8180 | -0.316 ± 2.3086 | -0.100 ± 1.4942 | -0.894 ± 1.7119 | -0.342 ± 1.5683 |
| Leukocytes Week 32 | -0.762 ± 1.4273 | -0.862 ± 2.0091 | -0.330 ± 1.5750 | -0.918 ± 2.6184 | -0.505 ± 1.4800 |
| Leukocytes Week 36 | -0.541 ± 1.5971 | -0.974 ± 1.7389 | -0.366 ± 1.4549 | -1.082 ± 2.3389 | -0.126 ± 2.2565 |
| Leukocytes Week 40 | -0.783 ± 1.7693 | -0.826 ± 1.5942 | -0.437 ± 1.7878 | -1.226 ± 2.3856 | -0.266 ± 1.7976 |
| Leukocytes Week 44 | -1.065 ± 1.6070 | -0.978 ± 1.8151 | -0.537 ± 1.5641 | -1.032 ± 2.1585 | -0.825 ± 1.8917 |
| Leukocytes Week 48 | -0.739 ± 1.7774 | -0.869 ± 1.7109 | -0.473 ± 1.7104 | -1.225 ± 2.5952 | -0.777 ± 1.8593 |
| Lymphocytes Week 1 | -0.083 ± 0.5074 | -0.024 ± 0.4142 | 0.044 ± 0.5039 | -0.017 ± 0.4189 | 0.020 ± 0.3006 |
| Lymphocytes Week 2 | 0.105 ± 0.3246 | 0.026 ± 0.4137 | 0.021 ± 0.6006 | 0.007 ± 0.3643 | 0.161 ± 0.4277 |
| Lymphocytes Week 4 | 0.037 ± 0.4386 | 0.024 ± 0.3259 | 0.010 ± 0.6003 | -0.032 ± 0.3996 | 0.095 ± 0.3263 |
| Lymphocytes Week 8 | 0.120 ± 0.3776 | 0.054 ± 0.3783 | 0.063 ± 0.5928 | 0.053 ± 0.4980 | 0.129 ± 0.3939 |
| Lymphocytes Week 12 | 0.041 ± 0.3647 | 0.051 ± 0.4167 | 0.000 ± 0.5640 | -0.047 ± 0.3703 | 0.061 ± 0.3301 |
| Lymphocytes Week 16 | 0.052 ± 0.5567 | 0.071 ± 0.3571 | 0.026 ± 0.5539 | -0.029 ± 0.4991 | 0.135 ± 0.4197 |
| Lymphocytes Week 20 | 0.003 ± 0.4934 | 0.008 ± 0.3970 | 0.149 ± 0.4675 | -0.035 ± 0.4566 | 0.126 ± 0.4216 |
| Lymphocytes Week 24 | -0.041 ± 0.3905 | 0.050 ± 0.3630 | 0.048 ± 0.4455 | -0.036 ± 0.3788 | 0.053 ± 0.3974 |
| Lymphocytes Week 28 | 0.036 ± 0.5869 | 0.105 ± 0.3594 | 0.210 ± 0.5999 | 0.103 ± 0.5544 | 0.172 ± 0.3776 |
| Lymphocytes Week 32 | -0.000 ± 0.5109 | 0.103 ± 0.4233 | 0.083 ± 0.6524 | 0.112 ± 0.5056 | 0.146 ± 0.3966 |
| Lymphocytes Week 36 | 0.078 ± 0.4894 | 0.039 ± 0.4227 | 0.134 ± 0.5673 | 0.103 ± 0.5491 | 0.118 ± 0.3810 |
| Lymphocytes Week 40 | 0.139 ± 0.4871 | 0.168 ± 0.4281 | 0.120 ± 0.6018 | 0.038 ± 0.4335 | 0.176 ± 0.3709 |
| Lymphocytes Week 44 | -0.008 ± 0.5390 | 0.105 ± 0.4136 | 0.124 ± 0.5366 | 0.115 ± 0.4881 | 0.153 ± 0.4462 |
| Lymphocytes Week 48 | 0.066 ± 0.5313 | 0.103 ± 0.3645 | 0.078 ± 0.5041 | 0.019 ± 0.3763 | 0.072 ± 0.3755 |
| Monocytes Week 1 | 0.007 ± 0.2184 | -0.008 ± 0.1477 | -0.012 ± 0.1679 | -0.088 ± 0.2315 | -0.027 ± 0.1724 |
| Monocytes Week 2 | 0.076 ± 0.1358 | -0.011 ± 0.1673 | 0.014 ± 0.1897 | -0.095 ± 0.2701 | -0.010 ± 0.1882 |
| Monocytes Week 4 | 0.032 ± 0.1588 | -0.021 ± 0.1473 | -0.040 ± 0.1862 | -0.066 ± 0.2404 | -0.085 ± 0.1459 |
| Monocytes Week 8 | 0.059 ± 0.1910 | -0.041 ± 0.1743 | 0.005 ± 0.1580 | -0.103 ± 0.2520 | -0.071 ± 0.1834 |
| Monocytes Week 12 | 0.020 ± 0.1913 | -0.031 ± 0.1608 | -0.033 ± 0.1686 | -0.105 ± 0.2630 | -0.059 ± 0.1414 |
| Monocytes Week 16 | -0.007 ± 0.1629 | -0.050 ± 0.1673 | -0.024 ± 0.1265 | -0.079 ± 0.2384 | -0.043 ± 0.1752 |
| Monocytes Week 20 | -0.008 ± 0.1783 | -0.041 ± 0.1534 | -0.015 ± 0.1509 | -0.081 ± 0.2448 | -0.003 ± 0.1899 |
| Monocytes Week 24 | -0.026 ± 0.1292 | -0.034 ± 0.1361 | 0.003 ± 0.1476 | -0.056 ± 0.2602 | -0.027 ± 0.1921 |
| Monocytes Week 28 | 0.026 ± 0.2087 | 0.042 ± 0.1981 | 0.055 ± 0.1724 | -0.029 ± 0.2729 | -0.012 ± 0.1911 |
| Monocytes Week 32 | 0.064 ± 0.2356 | -0.005 ± 0.1731 | -0.003 ± 0.1271 | -0.035 ± 0.2684 | 0.010 ± 0.1744 |
| Monocytes Week 36 | 0.054 ± 0.1626 | -0.024 ± 0.1792 | 0.032 ± 0.1404 | -0.036 ± 0.2644 | 0.049 ± 0.2327 |
| Monocytes Week 40 | 0.053 ± 0.1647 | 0.008 ± 0.1323 | 0.020 ± 0.1636 | -0.059 ± 0.2830 | -0.018 ± 0.1504 |
| Monocytes Week 44 | 0.019 ± 0.1939 | -0.008 ± 0.1588 | 0.044 ± 0.1644 | -0.032 ± 0.2446 | -0.019 ± 0.2202 |
| Monocytes Week 48 | 0.021 ± 0.2145 | 0.000 ± 0.1707 | -0.013 ± 0.1399 | -0.078 ± 0.2511 | -0.077 ± 0.1709 |
| Neutrophils Week 1 | -0.200 ± 1.0959 | -0.558 ± 0.9627 | -0.693 ± 1.2971 | -0.934 ± 1.4768 | -0.325 ± 1.5720 |
| Neutrophils Week 2 | -0.026 ± 1.1945 | -0.418 ± 1.1627 | -0.337 ± 1.3109 | -0.880 ± 1.8457 | -0.537 ± 1.3989 |
| Neutrophils Week 4 | -0.102 ± 1.0044 | -0.405 ± 1.1246 | -0.290 ± 1.3463 | -0.924 ± 1.9975 | -0.732 ± 1.4028 |
| Neutrophils Week 8 | 0.249 ± 1.5358 | -0.346 ± 1.2640 | -0.256 ± 1.3898 | -1.021 ± 1.7129 | -0.717 ± 1.4589 |
| Neutrophils Week 12 | 0.117 ± 1.5103 | -0.456 ± 1.1227 | -0.458 ± 1.6879 | -0.832 ± 2.2192 | -0.673 ± 1.3887 |
| Neutrophils Week 16 | -0.490 ± 1.6866 | -0.879 ± 1.5752 | -0.617 ± 1.6027 | -1.203 ± 2.2840 | -0.448 ± 1.6816 |
| Neutrophils Week 20 | -0.972 ± 1.2085 | -1.069 ± 1.4219 | -0.595 ± 1.4319 | -0.827 ± 2.2663 | -0.618 ± 1.5716 |
| Neutrophils Week 24 | -1.210 ± 1.4067 | -0.895 ± 1.6288 | -0.593 ± 1.5309 | -1.011 ± 2.2968 | -0.850 ± 1.6461 |
| Neutrophils Week 28 | -0.774 ± 1.8189 | -0.484 ± 2.2620 | -0.555 ± 1.2608 | -0.949 ± 1.7676 | -0.568 ± 1.3889 |
| Neutrophils Week 32 | -0.869 ± 1.2796 | -0.969 ± 1.8241 | -0.433 ± 1.7889 | -1.038 ± 2.4800 | -0.718 ± 1.4299 |
| Neutrophils Week 36 | -0.722 ± 1.6422 | -0.992 ± 1.6583 | -0.541 ± 1.5519 | -1.185 ± 2.1881 | -0.354 ± 2.1441 |
| Neutrophils Week 40 | -1.006 ± 1.7393 | -0.992 ± 1.4740 | -0.575 ± 1.9567 | -1.229 ± 2.4065 | -0.495 ± 1.5857 |
| Neutrophils Week 44 | -0.978 ± 1.2444 | -1.086 ± 1.6049 | -0.717 ± 1.6966 | -1.109 ± 2.2673 | -0.983 ± 1.6556 |
| Neutrophils Week 48 | -0.861 ± 1.6858 | -0.939 ± 1.5670 | -0.558 ± 1.7944 | -1.178 ± 2.6503 | -0.805 ± 1.6631 |
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
| g/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Ery. mean corpuscular HGB Week 1 | -2.293 ± 8.4594 | 0.789 ± 8.9719 | -1.860 ± 8.0551 | 0.927 ± 9.1088 | 1.200 ± 12.2395 |
| Ery. mean corpuscular HGB Week 2 | -2.310 ± 7.9923 | 2.564 ± 9.8216 | 0.465 ± 8.4778 | 0.707 ± 8.6263 | 2.854 ± 10.1822 |
| Ery. mean corpuscular HGB Week 4 | -3.927 ± 10.0633 | 1.474 ± 10.5849 | -2.500 ± 11.5045 | -0.878 ± 9.4026 | 1.756 ± 11.8697 |
| Ery. mean corpuscular HGB Week 8 | -5.195 ± 11.7158 | -1.897 ± 11.3249 | -3.780 ± 10.7576 | -3.079 ± 10.7033 | 0.610 ± 12.7493 |
| Ery. mean corpuscular HGB Week 12 | -7.927 ± 14.6704 | -3.179 ± 13.4122 | -3.907 ± 11.5404 | -2.684 ± 9.4099 | 1.732 ± 13.3959 |
| Ery. mean corpuscular HGB Week 16 | -6.286 ± 12.3393 | -3.000 ± 14.5751 | -5.262 ± 12.1917 | -1.026 ± 11.6816 | -0.700 ± 16.1026 |
| Ery. mean corpuscular HGB Week 20 | -5.050 ± 12.8102 | 0.923 ± 11.8108 | -1.902 ± 12.8078 | 0.919 ± 8.7349 | 0.200 ± 16.1725 |
| Ery. mean corpuscular HGB Week 24 | 1.000 ± 10.9232 | 4.132 ± 10.3849 | -0.625 ± 14.6685 | 4.583 ± 11.3121 | 4.250 ± 13.4064 |
| Ery. mean corpuscular HGB Week 28 | 2.179 ± 10.3285 | 4.658 ± 9.6906 | 1.707 ± 9.9505 | 4.400 ± 13.7524 | 6.150 ± 12.5382 |
| Ery. mean corpuscular HGB Week 32 | 6.308 ± 9.7796 | 10.231 ± 9.5957 | 4.850 ± 11.3692 | 7.971 ± 12.3497 | 10.462 ± 12.9855 |
| Ery. mean corpuscular HGB Week 36 | 5.500 ± 9.7779 | 10.921 ± 10.2229 | 2.732 ± 12.4097 | 6.788 ± 12.2034 | 9.462 ± 12.7998 |
| Ery. mean corpuscular HGB Week 40 | 3.108 ± 9.8736 | 8.237 ± 12.0706 | 4.976 ± 11.5639 | 9.088 ± 11.5480 | 9.079 ± 11.5393 |
| Ery. mean corpuscular HGB Week 44 | 6.297 ± 10.6975 | 7.289 ± 12.6254 | 3.415 ± 12.6293 | 6.353 ± 14.3038 | 9.278 ± 12.8076 |
| Ery. mean corpuscular HGB Week 48 | 5.079 ± 10.4916 | 7.216 ± 9.3812 | 2.122 ± 11.8769 | 5.394 ± 12.9300 | 8.250 ± 11.3448 |
| Hemoglobin Week 1 | -4.854 ± 5.6726 | 0.000 ± 5.6569 | 1.302 ± 5.1480 | 0.512 ± 6.0462 | -0.875 ± 4.8368 |
| Hemoglobin Week 2 | -4.810 ± 6.5154 | -0.359 ± 5.2339 | 0.070 ± 6.5915 | -1.561 ± 6.7047 | 0.317 ± 5.3499 |
| Hemoglobin Week 4 | -4.390 ± 7.5162 | 0.895 ± 7.6434 | 0.881 ± 6.4551 | 0.512 ± 5.7189 | 1.195 ± 5.8916 |
| Hemoglobin Week 8 | -4.561 ± 7.0995 | 0.308 ± 7.0865 | 2.195 ± 7.7628 | 0.553 ± 6.8010 | 1.195 ± 7.4439 |
| Hemoglobin Week 12 | -5.220 ± 6.7879 | 0.692 ± 7.7601 | 2.488 ± 7.6512 | 0.868 ± 7.3344 | 2.488 ± 8.2344 |
| Hemoglobin Week 16 | -1.619 ± 6.4768 | 2.579 ± 8.3880 | 1.524 ± 8.7853 | 1.737 ± 7.3547 | 3.125 ± 7.7400 |
| Hemoglobin Week 20 | -0.400 ± 7.3233 | 2.667 ± 8.6764 | 2.268 ± 6.9822 | 1.892 ± 7.6186 | 2.925 ± 7.7207 |
| Hemoglobin Week 24 | 0.564 ± 8.1879 | 3.658 ± 9.0622 | 4.075 ± 8.0714 | 2.000 ± 6.6462 | 3.425 ± 6.2834 |
| Hemoglobin Week 28 | -1.513 ± 8.0259 | 3.342 ± 8.9511 | 3.122 ± 8.6261 | 0.857 ± 7.2645 | 3.400 ± 8.6730 |
| Hemoglobin Week 32 | -0.282 ± 8.2684 | 4.487 ± 8.3094 | 4.300 ± 9.4032 | 2.118 ± 7.4254 | 5.615 ± 8.6378 |
| Hemoglobin Week 36 | 0.947 ± 9.1738 | 6.053 ± 8.1405 | 4.293 ± 9.5766 | 3.818 ± 7.3334 | 4.949 ± 8.4851 |
| Hemoglobin Week 40 | 1.432 ± 9.1090 | 5.868 ± 8.7863 | 4.317 ± 9.6552 | 3.618 ± 7.8277 | 4.132 ± 7.7987 |
| Hemoglobin Week 44 | 1.486 ± 10.1040 | 5.000 ± 9.2998 | 3.659 ± 9.1750 | 4.912 ± 8.5895 | 4.722 ± 8.5511 |
| Hemoglobin Week 48 | 2.474 ± 9.7002 | 5.270 ± 9.1974 | 3.780 ± 9.9210 | 4.030 ± 9.2550 | 4.725 ± 7.3554 |
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
| picograms (pg) | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -0.073 ± 0.4980 | 0.058 ± 0.4624 | -0.049 ± 0.4050 | 0.073 ± 0.3975 | -0.055 ± 0.4455 |
| Week 2 | -0.050 ± 0.3890 | 0.126 ± 0.5149 | 0.023 ± 0.4225 | 0.066 ± 0.4357 | 0.085 ± 0.4287 |
| Week 4 | -0.112 ± 0.5501 | 0.089 ± 0.5584 | 0.060 ± 0.5910 | 0.012 ± 0.4691 | 0.066 ± 0.6085 |
| Week 8 | -0.110 ± 0.6778 | 0.141 ± 0.6801 | 0.007 ± 0.5926 | 0.034 ± 0.6851 | 0.095 ± 0.7994 |
| Week 12 | -0.285 ± 0.6770 | 0.023 ± 0.7253 | 0.091 ± 0.8358 | -0.132 ± 0.8335 | 0.039 ± 1.0454 |
| Week 16 | -0.233 ± 0.7281 | 0.097 ± 0.8824 | 0.014 ± 0.9236 | -0.118 ± 0.8440 | -0.067 ± 1.1713 |
| Week 20 | -0.290 ± 0.8145 | -0.033 ± 0.9172 | 0.029 ± 0.9819 | -0.035 ± 0.7013 | 0.075 ± 1.0824 |
| Week 24 | -0.249 ± 1.0443 | 0.108 ± 0.9947 | -0.057 ± 1.1804 | -0.097 ± 0.7284 | -0.007 ± 1.2338 |
| Week 28 | -0.103 ± 1.0101 | 0.029 ± 0.7241 | -0.122 ± 1.1130 | -0.211 ± 0.8277 | 0.020 ± 1.2950 |
| Week 32 | 0.003 ± 1.2619 | 0.297 ± 0.8561 | 0.058 ± 1.1522 | 0.026 ± 0.7684 | 0.167 ± 1.2472 |
| Week 36 | -0.082 ± 1.3242 | 0.237 ± 0.8722 | -0.093 ± 1.0792 | -0.248 ± 0.8581 | 0.118 ± 1.1473 |
| Week 40 | -0.170 ± 1.3453 | 0.134 ± 0.8960 | -0.134 ± 1.2095 | -0.147 ± 0.8645 | 0.034 ± 1.0839 |
| Week 44 | 0.097 ± 1.3103 | 0.129 ± 0.8742 | -0.080 ± 1.1771 | -0.159 ± 0.7480 | 0.108 ± 1.2532 |
| Week 48 | 0.137 ± 1.4139 | 0.178 ± 0.9369 | -0.120 ± 1.1279 | -0.030 ± 0.7888 | 0.140 ± 1.2161 |
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
| femtolitres (fL) | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | 0.422 ± 1.8855 | -0.087 ± 1.9540 | 0.386 ± 2.2542 | -0.017 ± 2.1066 | -0.510 ± 2.7686 |
| Week 2 | 0.450 ± 1.8867 | -0.362 ± 2.1689 | -0.021 ± 1.8767 | -0.039 ± 2.3876 | -0.549 ± 2.5751 |
| Week 4 | 0.829 ± 2.3409 | -0.163 ± 2.4631 | 0.945 ± 3.2325 | 0.354 ± 2.8851 | -0.259 ± 2.5328 |
| Week 8 | 1.163 ± 3.6524 | 0.938 ± 2.9445 | 1.110 ± 3.0283 | 0.916 ± 3.0058 | 0.090 ± 3.5125 |
| Week 12 | 1.478 ± 3.9560 | 0.951 ± 3.4617 | 1.367 ± 3.8471 | 0.342 ± 3.1129 | -0.390 ± 3.3907 |
| Week 16 | 1.107 ± 3.4022 | 1.168 ± 3.7760 | 1.571 ± 4.3326 | -0.016 ± 3.6944 | 0.048 ± 4.4345 |
| Week 20 | 0.497 ± 3.5197 | -0.349 ± 2.8975 | 0.649 ± 3.7758 | -0.338 ± 2.5959 | 0.202 ± 4.2993 |
| Week 24 | -1.033 ± 2.9007 | -0.858 ± 2.1793 | 0.143 ± 4.9985 | -1.522 ± 3.1692 | -1.195 ± 3.5759 |
| Week 28 | -0.910 ± 2.6477 | -1.184 ± 2.3264 | -0.754 ± 3.3662 | -1.854 ± 3.6605 | -1.638 ± 3.3447 |
| Week 32 | -1.654 ± 2.7565 | -1.851 ± 2.4024 | -1.075 ± 3.5390 | -2.071 ± 3.7652 | -2.351 ± 3.1052 |
| Week 36 | -1.724 ± 3.1037 | -2.266 ± 2.3516 | -0.912 ± 3.9627 | -2.558 ± 3.8468 | -2.236 ± 3.2869 |
| Week 40 | -1.386 ± 2.8575 | -1.882 ± 3.1285 | -1.698 ± 3.0263 | -2.885 ± 3.1443 | -2.421 ± 2.9445 |
| Week 44 | -1.405 ± 3.4627 | -1.632 ± 3.4207 | -1.117 ± 3.4616 | -2.171 ± 4.4367 | -2.186 ± 3.4915 |
| Week 48 | -0.942 ± 3.5913 | -1.492 ± 2.5065 | -0.846 ± 3.1243 | -1.527 ± 3.6540 | -1.788 ± 3.5554 |
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
| 10^12 red blood cells per liter | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -0.148 ± 0.2071 | -0.008 ± 0.1927 | 0.050 ± 0.1773 | 0.008 ± 0.2109 | -0.017 ± 0.1609 |
| Week 2 | -0.149 ± 0.2244 | -0.029 ± 0.1788 | -0.004 ± 0.2280 | -0.063 ± 0.2236 | 0.000 ± 0.1809 |
| Week 4 | -0.132 ± 0.2780 | 0.018 ± 0.2535 | 0.023 ± 0.2135 | 0.013 ± 0.1955 | 0.031 ± 0.2065 |
| Week 8 | -0.135 ± 0.2546 | -0.011 ± 0.2206 | 0.074 ± 0.2466 | 0.014 ± 0.2190 | 0.026 ± 0.2264 |
| Week 12 | -0.131 ± 0.2678 | 0.021 ± 0.2561 | 0.069 ± 0.2419 | 0.051 ± 0.2243 | 0.075 ± 0.2393 |
| Week 16 | -0.020 ± 0.2375 | 0.075 ± 0.2898 | 0.047 ± 0.2810 | 0.074 ± 0.2255 | 0.110 ± 0.2533 |
| Week 20 | 0.036 ± 0.2618 | 0.096 ± 0.2855 | 0.068 ± 0.2089 | 0.064 ± 0.2273 | 0.081 ± 0.2191 |
| Week 24 | 0.059 ± 0.2639 | 0.110 ± 0.2974 | 0.142 ± 0.2573 | 0.074 ± 0.2250 | 0.110 ± 0.1931 |
| Week 28 | -0.034 ± 0.2453 | 0.108 ± 0.2681 | 0.122 ± 0.2445 | 0.058 ± 0.2359 | 0.106 ± 0.2567 |
| Week 32 | -0.010 ± 0.2461 | 0.104 ± 0.2660 | 0.133 ± 0.2716 | 0.061 ± 0.2555 | 0.156 ± 0.2714 |
| Week 36 | 0.044 ± 0.2524 | 0.166 ± 0.2542 | 0.156 ± 0.2849 | 0.161 ± 0.2399 | 0.145 ± 0.2377 |
| Week 40 | 0.079 ± 0.2682 | 0.177 ± 0.2733 | 0.163 ± 0.2736 | 0.141 ± 0.2535 | 0.129 ± 0.2403 |
| Week 44 | 0.035 ± 0.2645 | 0.146 ± 0.2846 | 0.133 ± 0.2622 | 0.188 ± 0.2933 | 0.135 ± 0.2128 |
| Week 48 | 0.061 ± 0.2693 | 0.146 ± 0.2994 | 0.141 ± 0.2747 | 0.135 ± 0.2934 | 0.129 ± 0.2354 |
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
| volume % of red blood cells | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -0.011 ± 0.0189 | -0.001 ± 0.0211 | 0.007 ± 0.0181 | 0.000 ± 0.0206 | -0.004 ± 0.0206 |
| Week 2 | -0.011 ± 0.0230 | -0.004 ± 0.0204 | -0.000 ± 0.0205 | -0.006 ± 0.0220 | -0.003 ± 0.0174 |
| Week 4 | -0.008 ± 0.0254 | 0.001 ± 0.0211 | 0.006 ± 0.0220 | 0.003 ± 0.0190 | 0.001 ± 0.0209 |
| Week 8 | -0.007 ± 0.0239 | 0.003 ± 0.0244 | 0.012 ± 0.0237 | 0.005 ± 0.0208 | 0.003 ± 0.0232 |
| Week 12 | -0.005 ± 0.0287 | 0.007 ± 0.0281 | 0.013 ± 0.0276 | 0.006 ± 0.0219 | 0.005 ± 0.0231 |
| Week 16 | 0.004 ± 0.0202 | 0.012 ± 0.0259 | 0.011 ± 0.0254 | 0.006 ± 0.0240 | 0.010 ± 0.0252 |
| Week 20 | 0.006 ± 0.0217 | 0.007 ± 0.0270 | 0.010 ± 0.0211 | 0.004 ± 0.0241 | 0.008 ± 0.0246 |
| Week 24 | 0.001 ± 0.0192 | 0.006 ± 0.0253 | 0.014 ± 0.0256 | -0.000 ± 0.0222 | 0.005 ± 0.0219 |
| Week 28 | -0.007 ± 0.0210 | 0.004 ± 0.0248 | 0.008 ± 0.0241 | -0.003 ± 0.0229 | 0.002 ± 0.0238 |
| Week 32 | -0.009 ± 0.0207 | 0.000 ± 0.0249 | 0.007 ± 0.0225 | -0.004 ± 0.0196 | 0.003 ± 0.0248 |
| Week 36 | -0.004 ± 0.0222 | 0.004 ± 0.0228 | 0.009 ± 0.0258 | 0.003 ± 0.0221 | 0.003 ± 0.0234 |
| Week 40 | 0.000 ± 0.0231 | 0.007 ± 0.0278 | 0.007 ± 0.0246 | -0.001 ± 0.0221 | 0.000 ± 0.0206 |
| Week 44 | -0.003 ± 0.0272 | 0.006 ± 0.0297 | 0.007 ± 0.0239 | 0.007 ± 0.0246 | 0.002 ± 0.0194 |
| Week 48 | 0.001 ± 0.0243 | 0.007 ± 0.0257 | 0.009 ± 0.0260 | 0.005 ± 0.0252 | 0.004 ± 0.0212 |
Platelets was measured in number of platelets per liter (10\^9/L).
| 10^9 platelets per liter | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -5.073 ± 30.2609 | -3.368 ± 25.9515 | 3.209 ± 30.5883 | -2.098 ± 24.6412 | -9.325 ± 23.4109 |
| Week 2 | 4.000 ± 27.3112 | -5.179 ± 38.2800 | -3.810 ± 41.8250 | -15.122 ± 32.8414 | -15.415 ± 31.7025 |
| Week 4 | -3.927 ± 29.6643 | -6.868 ± 29.7487 | -13.878 ± 43.7568 | -19.415 ± 32.6450 | -27.073 ± 41.9299 |
| Week 8 | 1.561 ± 29.1042 | -12.077 ± 28.9876 | -5.475 ± 44.7718 | -17.605 ± 29.8442 | -26.195 ± 44.1719 |
| Week 12 | -2.171 ± 32.0795 | -17.359 ± 35.4308 | -11.286 ± 40.7451 | -10.079 ± 44.8977 | -23.171 ± 47.2995 |
| Week 16 | -18.833 ± 50.4844 | -18.263 ± 37.3259 | -13.952 ± 50.7173 | -9.895 ± 35.3246 | -25.425 ± 37.6556 |
| Week 20 | -18.625 ± 50.3988 | -23.077 ± 39.6534 | -10.512 ± 48.0755 | -15.324 ± 28.8329 | -22.725 ± 42.2502 |
| Week 24 | -19.974 ± 49.0196 | -14.000 ± 37.7760 | -4.600 ± 49.4025 | -10.972 ± 36.8375 | -22.900 ± 47.4092 |
| Week 28 | -24.256 ± 51.8001 | -16.868 ± 40.6635 | -7.683 ± 47.8155 | -12.800 ± 30.7904 | -19.600 ± 42.3052 |
| Week 32 | -22.410 ± 51.9553 | -18.590 ± 41.7226 | -13.575 ± 51.9304 | -20.618 ± 38.8969 | -23.179 ± 42.2018 |
| Week 36 | -25.000 ± 52.6990 | -16.474 ± 46.8844 | -14.561 ± 50.2106 | -18.848 ± 40.0563 | -23.846 ± 45.1340 |
| Week 40 | -23.432 ± 53.2747 | -20.895 ± 41.4845 | -14.927 ± 51.2652 | -24.088 ± 33.4133 | -21.789 ± 46.1467 |
| Week 44 | -22.703 ± 57.8383 | -22.474 ± 41.0627 | -18.051 ± 49.1646 | -24.735 ± 38.4710 | -31.389 ± 48.5306 |
| Week 48 | -27.395 ± 56.2963 | -23.811 ± 47.1150 | -24.220 ± 46.2458 | -22.273 ± 37.4243 | -28.974 ± 42.9960 |
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
| U/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Alanine Aminotransferase Week 1 | -1.366 ± 12.7451 | 2.526 ± 15.5211 | 2.628 ± 42.1234 | 3.122 ± 10.2791 | 0.700 ± 9.5868 |
| Alanine Aminotransferase Week 2 | -1.714 ± 15.4624 | 2.026 ± 8.9428 | -1.047 ± 41.1223 | 4.927 ± 20.9623 | 1.171 ± 10.2978 |
| Alanine Aminotransferase Week 4 | -3.854 ± 15.1897 | 1.553 ± 16.2758 | -3.952 ± 38.9546 | 22.756 ± 139.8531 | -1.561 ± 10.1392 |
| Alanine Aminotransferase Week 8 | -4.707 ± 13.6478 | -1.385 ± 9.4580 | 5.465 ± 68.0764 | 0.795 ± 11.4321 | -1.659 ± 11.1009 |
| Alanine Aminotransferase Week 12 | -4.220 ± 15.1765 | 0.359 ± 12.2356 | -4.429 ± 38.1756 | 1.184 ± 13.0692 | -1.390 ± 8.1941 |
| Alanine Aminotransferase Week 16 | -2.048 ± 18.0026 | 2.684 ± 16.3229 | -4.857 ± 38.6211 | 0.579 ± 12.9273 | 0.829 ± 11.5432 |
| Alanine Aminotransferase Week 20 | 0.300 ± 39.9482 | 3.821 ± 13.0139 | -4.881 ± 39.1808 | -0.838 ± 11.1118 | -1.350 ± 10.5479 |
| Alanine Aminotransferase Week 24 | -1.564 ± 19.4974 | 2.789 ± 14.5475 | -5.659 ± 39.6652 | 1.528 ± 11.0259 | -3.475 ± 8.6202 |
| Alanine Aminotransferase Week 28 | -3.385 ± 17.7373 | 2.658 ± 12.8174 | -3.244 ± 43.4688 | -0.171 ± 8.7228 | -2.775 ± 10.4280 |
| Alanine Aminotransferase Week 32 | -4.487 ± 16.5400 | 2.385 ± 12.8956 | -4.150 ± 44.0126 | -2.176 ± 12.7742 | -0.821 ± 11.5482 |
| Alanine Aminotransferase Week 36 | 0.579 ± 10.5411 | 0.184 ± 11.8660 | -2.976 ± 42.9275 | -0.471 ± 11.2848 | -1.103 ± 10.6296 |
| Alanine Aminotransferase Week 40 | -0.622 ± 10.2506 | 0.816 ± 12.6680 | -2.780 ± 44.9719 | -3.853 ± 11.1059 | -1.385 ± 13.1061 |
| Alanine Aminotransferase Week 44 | 2.649 ± 19.7993 | 1.474 ± 13.1514 | -3.415 ± 43.2966 | -3.882 ± 12.8741 | -2.692 ± 10.2525 |
| Alanine Aminotransferase Week 48 | 2.605 ± 14.0646 | 2.216 ± 12.8542 | -4.561 ± 43.1926 | -3.794 ± 13.1628 | -0.575 ± 9.6181 |
| Alkaline Phosphatase Week 1 | -1.098 ± 6.0034 | -1.342 ± 8.0983 | -2.721 ± 7.2056 | -3.244 ± 4.9989 | -4.275 ± 7.1360 |
| Alkaline Phosphatase Week 2 | -1.905 ± 6.7960 | -3.282 ± 7.8370 | -4.349 ± 9.5963 | -4.805 ± 7.8237 | -3.585 ± 8.8430 |
| Alkaline Phosphatase Week 4 | -1.634 ± 9.0630 | -1.077 ± 10.4236 | -3.262 ± 9.9144 | -1.439 ± 18.3508 | -4.829 ± 10.9268 |
| Alkaline Phosphatase Week 8 | -2.220 ± 8.3711 | 0.308 ± 12.6515 | 1.233 ± 37.8014 | -5.026 ± 10.2019 | -3.585 ± 9.8336 |
| Alkaline Phosphatase Week 12 | -2.463 ± 8.8122 | -0.462 ± 12.1066 | -5.952 ± 11.0695 | -4.947 ± 12.0538 | -3.146 ± 17.2476 |
| Alkaline Phosphatase Week 16 | -8.357 ± 12.7276 | -0.895 ± 13.1515 | -7.238 ± 10.7722 | -4.605 ± 11.6539 | -1.512 ± 25.7722 |
| Alkaline Phosphatase Week 20 | -10.425 ± 14.0510 | -5.410 ± 15.1895 | -10.143 ± 13.0264 | -7.027 ± 11.8544 | -6.650 ± 14.8143 |
| Alkaline Phosphatase Week 24 | -12.795 ± 15.4752 | -4.769 ± 13.8097 | -9.463 ± 11.3448 | -6.361 ± 12.7843 | -7.225 ± 18.4231 |
| Alkaline Phosphatase Week 28 | -12.795 ± 16.9351 | -5.684 ± 15.7259 | -11.244 ± 12.6249 | -8.314 ± 10.9054 | -8.525 ± 16.8523 |
| Alkaline Phosphatase Week 32 | -13.667 ± 16.1870 | -4.769 ± 16.1530 | -10.900 ± 13.0026 | -9.118 ± 12.5765 | -8.385 ± 17.5988 |
| Alkaline Phosphatase Week 36 | -11.816 ± 19.2436 | -6.368 ± 15.4735 | -11.122 ± 12.3495 | -8.059 ± 9.5217 | -6.487 ± 19.2434 |
| Alkaline Phosphatase Week 40 | -11.000 ± 16.9706 | -5.658 ± 15.7485 | -11.024 ± 12.9180 | -10.559 ± 11.6987 | -8.175 ± 17.8884 |
| Alkaline Phosphatase Week 44 | -12.622 ± 17.6373 | -6.421 ± 14.9099 | -10.537 ± 13.5759 | -8.647 ± 10.5483 | -8.950 ± 18.3162 |
| Alkaline Phosphatase Week 48 | -12.211 ± 19.0379 | -6.500 ± 16.5313 | -11.049 ± 14.4827 | -7.765 ± 12.3290 | -7.875 ± 20.1370 |
| Aspartate Aminotransferase Week 1 | -2.854 ± 10.3212 | 1.447 ± 6.2155 | -0.023 ± 27.5409 | 2.244 ± 6.7889 | 0.475 ± 5.2963 |
| Aspartate Aminotransferase Week 2 | -1.762 ± 10.5294 | 0.487 ± 4.0967 | -2.233 ± 26.3266 | 3.805 ± 14.7635 | 0.780 ± 6.1746 |
| Aspartate Aminotransferase Week 4 | -3.976 ± 10.6642 | 1.289 ± 7.5584 | -3.262 ± 25.1047 | 8.927 ± 52.0660 | -1.195 ± 4.2791 |
| Aspartate Aminotransferase Week 8 | -3.537 ± 10.5477 | -0.077 ± 5.8687 | 2.279 ± 34.7805 | 1.410 ± 5.5900 | 0.366 ± 6.1877 |
| Aspartate Aminotransferase Week 12 | -3.049 ± 12.2106 | 0.436 ± 5.3054 | -2.595 ± 22.5324 | 1.053 ± 6.9006 | 1.122 ± 6.2897 |
| Aspartate Aminotransferase Week 16 | -1.048 ± 12.1313 | 2.974 ± 8.3649 | -2.595 ± 24.3852 | 1.526 ± 6.6688 | 2.122 ± 6.1733 |
| Aspartate Aminotransferase Week 20 | 6.375 ± 60.1309 | 2.821 ± 6.6367 | -1.095 ± 25.1317 | 1.324 ± 7.1065 | 0.500 ± 4.8569 |
| Aspartate Aminotransferase Week 24 | 1.718 ± 23.7940 | 2.237 ± 6.9182 | -1.902 ± 26.1054 | 2.889 ± 6.2554 | 0.325 ± 4.3759 |
| Aspartate Aminotransferase Week 28 | -1.179 ± 13.4905 | 2.289 ± 6.9512 | -1.805 ± 27.4583 | 2.229 ± 6.3063 | 0.175 ± 4.1255 |
| Aspartate Aminotransferase Week 32 | -1.385 ± 12.2895 | 1.949 ± 6.2826 | -0.575 ± 28.3177 | 0.324 ± 6.2654 | 2.051 ± 4.9997 |
| Aspartate Aminotransferase Week 36 | 0.711 ± 7.3113 | 1.026 ± 5.5140 | -1.220 ± 25.5798 | 1.588 ± 6.6017 | 1.667 ± 6.0755 |
| Aspartate Aminotransferase Week 40 | 0.946 ± 12.1494 | 1.316 ± 5.5269 | 0.244 ± 29.2701 | -0.647 ± 6.0597 | 2.462 ± 8.4972 |
| Aspartate Aminotransferase Week 44 | 2.838 ± 15.4641 | 2.553 ± 7.9175 | -1.268 ± 28.4280 | -0.588 ± 7.7190 | 1.590 ± 6.9347 |
| Aspartate Aminotransferase Week 48 | 2.158 ± 9.7939 | 3.459 ± 6.3403 | -1.927 ± 28.3182 | 0.441 ± 6.6796 | 2.900 ± 6.2339 |
| Gamma Glutamyl Transferase Week 1 | 0.171 ± 5.4447 | -2.737 ± 7.0354 | -0.535 ± 10.8745 | 0.171 ± 5.0245 | -2.300 ± 6.2684 |
| Gamma Glutamyl Transferase Week 2 | -0.190 ± 5.8736 | -2.026 ± 7.6828 | -4.116 ± 25.7527 | -0.341 ± 5.2517 | -1.268 ± 7.8773 |
| Gamma Glutamyl Transferase Week 4 | -0.220 ± 7.2129 | -2.641 ± 9.9167 | -6.143 ± 35.5504 | 1.171 ± 17.6265 | 0.512 ± 16.3968 |
| Gamma Glutamyl Transferase Week 8 | -1.829 ± 5.9745 | -4.410 ± 11.6319 | 11.581 ± 103.8974 | -1.795 ± 5.7454 | -1.805 ± 9.0698 |
| Gamma Glutamyl Transferase Week 12 | -0.585 ± 5.9033 | -2.154 ± 10.7643 | -5.762 ± 34.8767 | -0.447 ± 8.3785 | 3.244 ± 21.8229 |
| Gamma Glutamyl Transferase Week 16 | -0.357 ± 9.6445 | -1.842 ± 13.4476 | -4.357 ± 34.0020 | -0.947 ± 8.1868 | 15.024 ± 77.1617 |
| Gamma Glutamyl Transferase Week 20 | -0.750 ± 9.5051 | -2.769 ± 13.0555 | -5.452 ± 32.1970 | -1.649 ± 5.5137 | 1.475 ± 22.2722 |
| Gamma Glutamyl Transferase Week 24 | -0.615 ± 12.4173 | -2.769 ± 10.9339 | -4.122 ± 36.6832 | -2.639 ± 9.4360 | -2.625 ± 10.3272 |
| Gamma Glutamyl Transferase Week 28 | -0.462 ± 11.5618 | -2.132 ± 11.7638 | -6.341 ± 36.7434 | -2.629 ± 7.6354 | -0.200 ± 11.5585 |
| Gamma Glutamyl Transferase Week 32 | 0.359 ± 15.7872 | -1.538 ± 13.2463 | -7.875 ± 36.9103 | -3.676 ± 8.6435 | 2.795 ± 21.1501 |
| Gamma Glutamyl Transferase Week 36 | -0.026 ± 14.7162 | -4.289 ± 11.4559 | -8.195 ± 38.6899 | -2.735 ± 7.1236 | 1.410 ± 18.0200 |
| Gamma Glutamyl Transferase Week 40 | -2.568 ± 9.3676 | -3.842 ± 13.9275 | -9.073 ± 40.5792 | -4.088 ± 7.5573 | 0.925 ± 20.1066 |
| Gamma Glutamyl Transferase Week 44 | 1.081 ± 23.2108 | -1.289 ± 21.3730 | -7.488 ± 34.4145 | -3.824 ± 7.0430 | -0.949 ± 11.5643 |
| Gamma Glutamyl Transferase Week 48 | 1.474 ± 17.6723 | -2.184 ± 12.0850 | -7.805 ± 35.4924 | -2.941 ± 8.8247 | 2.525 ± 20.6112 |
| Lactate Dehydrogenase Week 1 | -7.000 ± 16.1509 | 0.026 ± 19.6118 | -1.163 ± 33.1669 | -0.585 ± 16.6673 | -1.075 ± 18.4341 |
| Lactate Dehydrogenase Week 2 | -5.929 ± 18.4858 | -0.410 ± 14.9045 | -5.930 ± 32.8325 | -2.439 ± 19.2146 | 0.537 ± 19.7270 |
| Lactate Dehydrogenase Week 4 | -5.634 ± 25.5693 | 4.846 ± 21.4372 | -6.190 ± 29.5265 | 0.854 ± 26.6238 | -4.293 ± 17.4732 |
| Lactate Dehydrogenase Week 8 | -3.561 ± 17.3249 | 0.026 ± 19.0449 | 0.140 ± 38.8413 | 3.513 ± 18.6503 | 1.439 ± 24.0230 |
| Lactate Dehydrogenase Week 12 | -0.927 ± 28.3058 | 4.077 ± 21.0905 | 2.119 ± 27.5134 | 3.342 ± 17.0346 | 1.049 ± 22.9303 |
| Lactate Dehydrogenase Week 16 | 0.881 ± 26.0180 | 15.447 ± 62.0267 | -4.381 ± 35.9600 | 0.474 ± 19.8967 | 1.488 ± 21.8325 |
| Lactate Dehydrogenase Week 20 | 1.200 ± 35.1817 | 2.154 ± 22.8825 | 2.500 ± 31.6145 | 0.676 ± 20.9206 | 2.025 ± 23.0401 |
| Lactate Dehydrogenase Week 24 | 4.462 ± 31.9282 | 1.333 ± 22.1862 | 2.878 ± 44.9662 | 1.944 ± 23.5638 | 8.550 ± 25.3093 |
| Lactate Dehydrogenase Week 28 | 1.436 ± 21.1122 | -4.763 ± 21.2138 | -2.902 ± 34.3590 | 8.143 ± 44.0929 | 1.250 ± 22.0962 |
| Lactate Dehydrogenase Week 32 | -6.333 ± 23.0587 | -6.410 ± 23.8324 | -4.525 ± 35.2762 | -2.971 ± 27.9171 | -1.615 ± 24.8052 |
| Lactate Dehydrogenase Week 36 | 0.553 ± 37.3889 | -4.658 ± 16.8383 | -7.585 ± 35.0442 | -6.147 ± 21.6895 | 5.436 ± 30.0436 |
| Lactate Dehydrogenase Week 40 | -0.216 ± 34.5214 | -8.289 ± 17.4896 | -6.366 ± 36.6898 | -10.618 ± 24.4293 | 0.000 ± 29.3852 |
| Lactate Dehydrogenase Week 44 | -0.757 ± 32.2847 | -5.316 ± 21.4805 | -5.000 ± 34.6259 | -5.059 ± 22.2683 | 1.675 ± 24.9588 |
| Lactate Dehydrogenase Week 48 | 4.447 ± 34.3493 | -1.395 ± 23.8061 | -4.707 ± 38.6654 | -7.441 ± 23.0443 | 4.500 ± 37.8120 |
Albumin was measured in grams per liter (g/L).
| g/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -1.000 ± 1.7464 | -0.079 ± 2.1357 | 0.279 ± 1.8038 | -0.439 ± 1.8715 | -0.350 ± 1.6259 |
| Week 2 | -0.500 ± 2.0982 | 0.051 ± 1.5719 | 0.419 ± 1.9908 | -0.537 ± 2.0988 | -0.073 ± 1.8220 |
| Week 4 | -0.683 ± 2.4743 | 0.538 ± 2.1007 | 0.595 ± 1.9514 | -0.171 ± 1.9862 | 0.220 ± 1.9687 |
| Week 8 | -0.634 ± 2.0094 | 0.154 ± 2.1829 | 0.581 ± 2.0843 | 0.077 ± 2.2051 | 0.195 ± 1.7638 |
| Week 12 | 0.073 ± 2.4020 | 0.538 ± 2.1986 | 0.857 ± 1.8685 | 0.211 ± 1.9474 | 0.415 ± 2.1210 |
| Week 16 | 0.833 ± 1.8468 | 1.132 ± 2.2800 | 0.881 ± 2.0025 | 0.316 ± 2.0678 | 0.683 ± 1.9422 |
| Week 20 | 0.175 ± 1.9333 | 0.487 ± 2.4047 | 0.976 ± 1.7873 | -0.081 ± 2.1000 | 0.575 ± 1.8659 |
| Week 24 | 0.385 ± 1.7262 | 0.949 ± 2.3164 | 1.341 ± 1.8790 | 0.722 ± 2.2502 | 0.875 ± 2.3004 |
| Week 28 | -0.462 ± 2.0881 | 0.632 ± 2.1362 | 0.976 ± 1.9169 | 0.114 ± 1.9819 | 0.525 ± 2.0999 |
| Week 32 | -0.179 ± 1.7452 | 0.359 ± 1.8706 | 0.700 ± 1.9897 | -0.235 ± 1.6341 | 0.667 ± 1.9912 |
| Week 36 | -0.289 ± 2.6397 | 0.816 ± 1.7220 | 0.659 ± 1.6064 | -0.029 ± 2.0815 | 0.436 ± 1.9166 |
| Week 40 | -0.108 ± 2.0109 | 0.763 ± 1.9650 | 0.805 ± 1.8196 | 0.000 ± 1.8749 | 0.400 ± 1.9716 |
| Week 44 | -0.297 ± 2.0120 | 0.132 ± 2.3269 | 0.659 ± 2.2429 | -0.206 ± 1.9661 | 0.175 ± 2.2858 |
| Week 48 | 0.132 ± 2.2800 | 0.632 ± 2.9903 | 0.366 ± 3.1682 | 0.088 ± 2.6671 | 0.150 ± 2.3044 |
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
| μmol/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Bilirubin Week 1 | -0.841 ± 2.8968 | -1.195 ± 3.1083 | -0.465 ± 3.4868 | 0.471 ± 3.0332 | 0.385 ± 2.2726 |
| Bilirubin Week 2 | -0.762 ± 2.9415 | 0.492 ± 3.1202 | 0.516 ± 2.7030 | 0.978 ± 2.9538 | 1.395 ± 4.0672 |
| Bilirubin Week 4 | -0.290 ± 3.4900 | 0.789 ± 2.8952 | -0.119 ± 3.2318 | 1.066 ± 3.4454 | 1.344 ± 3.7625 |
| Bilirubin Week 8 | -0.776 ± 3.7242 | 0.541 ± 3.1822 | 0.442 ± 3.8005 | 0.972 ± 3.4557 | 0.639 ± 2.8243 |
| Bilirubin Week 12 | -0.261 ± 2.6113 | 0.341 ± 3.0050 | 0.095 ± 2.5793 | 0.629 ± 3.2367 | 2.073 ± 4.0034 |
| Bilirubin Week 16 | 0.607 ± 3.7361 | 0.637 ± 3.7786 | 0.740 ± 3.2505 | 1.092 ± 3.7662 | 2.024 ± 3.7217 |
| Bilirubin Week 20 | -0.007 ± 3.3543 | 0.136 ± 3.4239 | 1.062 ± 3.8164 | 1.030 ± 3.8636 | 1.225 ± 2.9632 |
| Bilirubin Week 24 | 0.146 ± 3.2508 | 0.592 ± 4.4981 | 0.383 ± 3.1235 | 1.081 ± 2.8708 | 1.128 ± 2.8112 |
| Bilirubin Week 28 | -0.200 ± 3.6974 | -0.068 ± 3.8885 | 0.105 ± 2.5550 | 0.449 ± 3.4106 | 1.595 ± 3.4093 |
| Bilirubin Week 32 | 0.233 ± 3.2668 | 0.262 ± 3.7358 | 0.655 ± 3.1125 | 0.994 ± 2.6879 | 1.669 ± 4.0868 |
| Bilirubin Week 36 | 0.942 ± 3.6870 | 0.776 ± 4.3703 | 0.078 ± 3.8443 | 1.012 ± 3.5311 | 1.095 ± 2.3971 |
| Bilirubin Week 40 | 0.600 ± 3.8064 | 0.679 ± 3.4707 | 0.415 ± 3.3481 | 1.065 ± 3.1718 | 1.433 ± 3.3425 |
| Bilirubin Week 44 | -0.019 ± 3.6800 | -0.276 ± 3.1827 | -0.102 ± 3.1253 | 0.871 ± 2.8347 | 1.851 ± 3.7976 |
| Bilirubin Week 48 | 0.716 ± 4.0370 | 0.559 ± 3.2460 | 0.285 ± 3.8393 | 1.124 ± 3.2882 | 1.160 ± 3.9493 |
| Creatinine Week 1 | -0.512 ± 6.6788 | 0.368 ± 7.3757 | 2.442 ± 7.8628 | 1.366 ± 8.9044 | 1.300 ± 6.7300 |
| Creatinine Week 2 | 2.310 ± 11.1300 | 0.026 ± 6.1194 | 2.093 ± 8.4426 | 2.537 ± 6.8304 | 3.317 ± 6.7470 |
| Creatinine Week 4 | 0.854 ± 10.2508 | 1.256 ± 7.0812 | 1.762 ± 8.8229 | -0.561 ± 7.3418 | 2.171 ± 6.9279 |
| Creatinine Week 8 | 1.366 ± 8.3269 | 1.487 ± 8.3756 | 3.674 ± 10.1997 | 1.590 ± 7.9131 | 3.073 ± 5.7810 |
| Creatinine Week 12 | 1.268 ± 8.0282 | 0.949 ± 8.6113 | 6.214 ± 9.5062 | 1.947 ± 9.1236 | 2.220 ± 8.2417 |
| Creatinine Week 16 | 1.833 ± 8.4678 | 1.421 ± 10.7945 | 3.738 ± 7.7964 | 0.658 ± 8.7897 | 3.976 ± 8.2719 |
| Creatinine Week 20 | 3.150 ± 8.3468 | 1.051 ± 7.7966 | 4.976 ± 10.5818 | 2.270 ± 8.5461 | 4.525 ± 7.4144 |
| Creatinine Week 24 | 1.359 ± 8.1741 | 0.103 ± 6.8817 | 3.829 ± 11.4256 | 1.972 ± 9.3914 | 4.650 ± 7.2627 |
| Creatinine Week 28 | 2.921 ± 7.0227 | 1.737 ± 7.4858 | 4.634 ± 8.9576 | 1.371 ± 8.3634 | 4.900 ± 7.2388 |
| Creatinine Week 32 | 1.718 ± 8.8227 | 2.462 ± 9.1360 | 2.500 ± 8.9299 | 4.118 ± 12.0825 | 4.974 ± 7.7408 |
| Creatinine Week 36 | 0.289 ± 7.5656 | 1.632 ± 7.1600 | 1.024 ± 8.8218 | 1.853 ± 10.8492 | 3.462 ± 6.8127 |
| Creatinine Week 40 | 3.838 ± 9.5205 | 2.974 ± 7.3796 | 4.122 ± 9.7575 | 0.647 ± 10.7672 | 3.200 ± 7.0208 |
| Creatinine Week 44 | 4.543 ± 10.6670 | 4.250 ± 8.7876 | 3.659 ± 8.5311 | 3.364 ± 10.6853 | 3.925 ± 8.0012 |
| Creatinine Week 48 | 3.000 ± 10.3299 | 4.667 ± 8.5355 | 3.923 ± 7.7371 | 2.879 ± 9.8513 | 3.256 ± 7.0290 |
| Urate Week 1 | -1.220 ± 37.4503 | -0.237 ± 43.0100 | 11.953 ± 60.5652 | 8.732 ± 39.4088 | 11.650 ± 61.0924 |
| Urate Week 2 | 12.405 ± 47.5795 | -2.974 ± 44.8826 | 9.791 ± 61.4009 | 9.073 ± 39.3430 | 15.610 ± 49.0693 |
| Urate Week 4 | 10.171 ± 41.5493 | 0.308 ± 47.3193 | 13.452 ± 49.1633 | 5.659 ± 31.2591 | -4.293 ± 47.5753 |
| Urate Week 8 | 5.415 ± 42.9500 | -6.231 ± 40.4198 | 11.791 ± 64.9910 | 3.410 ± 33.9518 | 8.024 ± 44.0043 |
| Urate Week 12 | 10.707 ± 40.2208 | 6.795 ± 54.4814 | 13.881 ± 55.3332 | 7.553 ± 33.4904 | 2.805 ± 37.6651 |
| Urate Week 16 | 25.810 ± 44.1965 | 8.079 ± 50.0062 | 15.357 ± 59.0311 | 14.026 ± 40.5173 | 21.683 ± 41.1670 |
| Urate Week 20 | 28.950 ± 53.8602 | 4.692 ± 59.0420 | 16.048 ± 63.4346 | 10.622 ± 42.1567 | 10.600 ± 44.3262 |
| Urate Week 24 | 17.410 ± 45.0045 | 9.923 ± 54.9648 | 3.683 ± 58.6977 | 6.667 ± 45.2580 | 6.950 ± 45.8638 |
| Urate Week 28 | -0.897 ± 29.4331 | 9.447 ± 59.8655 | 18.976 ± 62.4894 | -6.371 ± 40.1227 | 1.250 ± 45.8972 |
| Urate Week 32 | 17.026 ± 47.8185 | 2.821 ± 48.9042 | 5.800 ± 56.2017 | 3.971 ± 45.1103 | 17.077 ± 40.3089 |
| Urate Week 36 | 0.211 ± 37.5630 | -4.868 ± 49.1419 | -10.927 ± 59.4228 | 4.735 ± 42.4309 | 5.846 ± 49.4259 |
| Urate Week 40 | 9.730 ± 43.5295 | 15.605 ± 53.8931 | 9.976 ± 62.8739 | -5.029 ± 41.2630 | 7.255 ± 46.0833 |
| Urate Week 44 | 20.541 ± 57.9164 | 7.605 ± 64.3342 | -8.854 ± 67.3523 | 1.382 ± 47.9558 | 10.675 ± 50.8963 |
| Urate Week 48 | 8.684 ± 53.6208 | 3.895 ± 48.5831 | -3.220 ± 64.9282 | 1.853 ± 54.8762 | 8.050 ± 49.1956 |
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
| mmol/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Calcium Week 1 | -0.034 ± 0.0810 | -0.017 ± 0.0984 | -0.008 ± 0.0858 | -0.002 ± 0.0990 | -0.014 ± 0.0897 |
| Calcium Week 2 | -0.021 ± 0.0951 | 0.002 ± 0.0973 | 0.009 ± 0.1304 | -0.024 ± 0.1001 | -0.022 ± 0.0938 |
| Calcium Week 4 | -0.029 ± 0.1079 | -0.011 ± 0.1015 | -0.021 ± 0.0973 | -0.047 ± 0.1147 | -0.020 ± 0.0917 |
| Calcium Week 8 | -0.024 ± 0.0942 | -0.006 ± 0.0926 | 0.008 ± 0.1260 | -0.004 ± 0.1105 | -0.022 ± 0.0975 |
| Calcium Week 12 | -0.021 ± 0.1009 | -0.025 ± 0.1090 | 0.021 ± 0.1057 | -0.020 ± 0.1088 | -0.025 ± 0.0923 |
| Calcium Week 16 | 0.004 ± 0.0826 | -0.006 ± 0.1079 | 0.023 ± 0.1334 | -0.004 ± 0.1027 | 0.005 ± 0.0888 |
| Calcium Week 20 | 0.002 ± 0.0931 | 0.000 ± 0.1013 | 0.017 ± 0.0999 | -0.008 ± 0.0948 | -0.018 ± 0.0919 |
| Calcium Week 24 | 0.011 ± 0.1019 | -0.002 ± 0.1028 | 0.015 ± 0.0845 | 0.004 ± 0.0896 | 0.003 ± 0.0974 |
| Calcium Week 28 | -0.027 ± 0.1117 | 0.002 ± 0.0877 | 0.009 ± 0.1068 | 0.008 ± 0.0909 | -0.021 ± 0.1043 |
| Calcium Week 32 | -0.023 ± 0.1069 | 0.000 ± 0.0952 | 0.001 ± 0.1074 | -0.017 ± 0.0932 | -0.008 ± 0.1024 |
| Calcium Week 36 | -0.013 ± 0.1172 | 0.007 ± 0.0804 | -0.005 ± 0.1096 | 0.001 ± 0.0972 | -0.015 ± 0.0936 |
| Calcium Week 40 | 0.003 ± 0.0905 | 0.001 ± 0.0807 | -0.007 ± 0.1084 | -0.019 ± 0.0809 | -0.025 ± 0.0947 |
| Calcium Week 44 | -0.027 ± 0.0920 | -0.018 ± 0.0861 | -0.008 ± 0.1023 | -0.019 ± 0.0839 | -0.042 ± 0.0972 |
| Calcium Week 48 | -0.010 ± 0.0881 | -0.009 ± 0.1033 | -0.014 ± 0.1126 | -0.014 ± 0.0912 | -0.034 ± 0.0861 |
| Chloride Week 1 | -0.195 ± 2.1121 | -0.105 ± 2.5446 | -0.674 ± 4.1388 | -0.244 ± 2.5572 | -0.125 ± 2.3986 |
| Chloride Week 2 | -0.214 ± 2.1131 | 0.308 ± 2.6273 | 0.093 ± 2.7500 | 0.415 ± 2.5296 | -0.439 ± 2.4192 |
| Chloride Week 4 | -0.293 ± 1.9525 | -0.333 ± 2.2750 | 0.000 ± 2.4792 | 0.024 ± 2.6409 | 0.000 ± 2.6363 |
| Chloride Week 8 | -0.537 ± 2.1920 | 0.615 ± 2.4346 | 0.047 ± 2.6988 | 0.538 ± 2.3038 | 0.683 ± 2.4025 |
| Chloride Week 12 | 0.341 ± 2.2205 | -0.282 ± 2.3946 | 0.548 ± 2.5681 | -0.211 ± 2.3499 | 0.000 ± 2.4393 |
| Chloride Week 16 | -0.310 ± 1.8934 | 0.026 ± 2.2837 | 0.190 ± 2.0864 | -0.184 ± 2.2644 | -0.268 ± 2.1334 |
| Chloride Week 20 | -0.325 ± 2.4640 | -0.538 ± 2.1502 | 0.262 ± 2.3484 | 0.162 ± 2.6616 | 0.075 ± 2.3685 |
| Chloride Week 24 | -0.615 ± 2.0081 | -0.128 ± 2.5462 | -0.390 ± 2.6351 | -0.306 ± 2.1885 | -0.050 ± 2.5415 |
| Chloride Week 28 | 0.128 ± 2.3190 | 0.000 ± 2.6913 | 0.195 ± 2.3154 | 0.086 ± 2.5365 | 0.250 ± 2.5090 |
| Chloride Week 32 | -0.154 ± 2.2069 | 0.436 ± 2.3708 | 0.500 ± 2.2072 | 0.794 ± 2.3196 | 0.282 ± 2.0641 |
| Chloride Week 36 | 0.237 ± 1.9923 | 0.684 ± 2.4285 | 0.732 ± 1.9239 | 0.294 ± 2.5999 | 0.205 ± 2.4299 |
| Chloride Week 40 | -0.054 ± 2.5380 | 0.263 ± 2.6271 | 0.707 ± 2.4418 | 0.824 ± 2.4676 | 0.500 ± 2.4495 |
| Chloride Week 44 | 0.135 ± 1.9027 | 0.579 ± 2.6977 | 0.756 ± 2.1069 | 0.882 ± 2.8044 | 0.200 ± 2.5840 |
| Chloride Week 48 | 0.605 ± 2.0994 | 0.737 ± 2.8158 | 1.024 ± 2.4545 | 0.971 ± 2.5044 | 0.725 ± 2.7826 |
| Cholesterol Week 1 | -0.254 ± 0.4371 | 0.032 ± 0.4307 | 0.244 ± 0.5220 | 0.105 ± 0.4690 | 0.102 ± 0.3965 |
| Cholesterol Week 2 | -0.224 ± 0.4154 | 0.108 ± 0.5132 | 0.295 ± 0.5178 | 0.054 ± 0.5441 | 0.222 ± 0.6101 |
| Cholesterol Week 4 | -0.198 ± 0.6334 | -0.023 ± 0.5905 | 0.210 ± 0.8027 | 0.093 ± 0.6525 | 0.151 ± 0.4178 |
| Cholesterol Week 8 | -0.190 ± 0.6935 | -0.023 ± 0.5770 | 0.284 ± 0.8012 | 0.074 ± 0.7920 | 0.061 ± 0.6268 |
| Cholesterol Week 12 | -0.124 ± 0.6719 | 0.013 ± 0.7473 | 0.117 ± 0.7616 | 0.005 ± 0.6045 | 0.212 ± 0.7491 |
| Cholesterol Week 16 | 0.095 ± 0.6811 | 0.184 ± 0.6378 | 0.138 ± 0.6814 | 0.068 ± 0.6014 | 0.249 ± 0.7075 |
| Cholesterol Week 20 | 0.053 ± 0.7609 | 0.126 ± 0.6889 | 0.186 ± 0.9669 | 0.116 ± 0.7101 | 0.115 ± 0.7718 |
| Cholesterol Week 24 | 0.041 ± 0.8729 | 0.013 ± 0.8673 | 0.127 ± 1.0682 | -0.003 ± 0.6984 | 0.077 ± 0.5686 |
| Cholesterol Week 28 | -0.044 ± 0.9797 | -0.037 ± 0.8930 | 0.076 ± 1.1434 | -0.037 ± 0.5801 | 0.100 ± 0.5923 |
| Cholesterol Week 32 | -0.085 ± 0.8540 | -0.079 ± 0.8918 | 0.175 ± 1.0895 | -0.050 ± 0.5945 | 0.256 ± 0.6920 |
| Cholesterol Week 36 | 0.005 ± 0.7322 | 0.024 ± 0.7951 | 0.117 ± 0.8408 | -0.038 ± 0.6597 | 0.144 ± 0.7950 |
| Cholesterol Week 40 | -0.103 ± 0.7541 | -0.118 ± 0.9109 | 0.183 ± 0.8947 | -0.135 ± 0.7454 | 0.110 ± 0.7824 |
| Cholesterol Week 44 | -0.170 ± 0.8082 | -0.176 ± 1.0874 | 0.071 ± 0.9341 | -0.218 ± 0.9150 | -0.000 ± 0.8407 |
| Cholesterol Week 48 | -0.282 ± 0.7891 | -0.279 ± 0.8348 | 0.012 ± 0.8883 | -0.253 ± 0.6653 | -0.083 ± 0.5817 |
| Glucose Week 1 | 0.307 ± 1.3942 | 0.103 ± 0.7027 | 0.077 ± 1.1366 | 0.173 ± 1.0232 | -0.060 ± 0.8445 |
| Glucose Week 2 | 0.062 ± 0.6681 | 0.013 ± 0.8348 | 0.221 ± 0.9652 | 0.129 ± 1.2364 | 0.190 ± 0.8938 |
| Glucose Week 4 | 0.298 ± 0.8575 | 0.015 ± 0.6888 | 0.248 ± 0.7693 | 0.249 ± 1.0659 | 0.134 ± 0.7428 |
| Glucose Week 8 | 0.112 ± 0.9127 | 0.308 ± 0.7696 | 0.258 ± 0.9254 | 0.344 ± 0.6939 | 0.256 ± 0.7075 |
| Glucose Week 12 | 0.110 ± 0.9146 | 0.005 ± 0.6117 | 0.188 ± 0.7533 | 0.111 ± 0.6455 | -0.124 ± 0.6636 |
| Glucose Week 16 | 0.176 ± 0.8363 | 0.195 ± 0.6316 | 0.424 ± 1.1521 | 0.276 ± 0.8280 | 0.398 ± 0.8332 |
| Glucose Week 20 | 0.208 ± 1.0560 | 0.315 ± 1.0225 | 0.267 ± 1.0132 | 0.632 ± 0.9741 | 0.165 ± 1.0366 |
| Glucose Week 24 | 0.018 ± 1.1856 | 0.092 ± 0.7747 | 0.328 ± 0.8554 | 0.061 ± 1.0462 | 0.037 ± 0.6295 |
| Glucose Week 28 | 0.246 ± 1.1812 | 0.263 ± 0.9371 | 0.322 ± 1.1372 | 0.263 ± 1.0053 | 0.262 ± 0.6412 |
| Glucose Week 32 | 0.333 ± 1.2671 | 0.236 ± 0.7013 | 0.570 ± 1.0301 | 0.356 ± 1.1021 | 0.203 ± 0.5945 |
| Glucose Week 36 | 0.089 ± 0.9061 | 0.342 ± 0.9406 | 0.234 ± 1.0379 | 0.174 ± 1.0175 | 0.290 ± 0.7789 |
| Glucose Week 40 | 0.143 ± 1.0885 | 0.245 ± 1.1081 | 0.507 ± 1.1257 | 0.203 ± 0.7420 | 0.125 ± 0.7016 |
| Glucose Week 44 | 0.222 ± 1.4919 | 0.200 ± 1.0950 | 0.185 ± 0.8688 | 0.303 ± 1.2760 | 0.197 ± 0.8966 |
| Glucose Week 48 | -0.013 ± 1.2512 | 0.045 ± 0.8472 | 0.141 ± 0.9341 | 0.276 ± 1.0841 | 0.100 ± 0.7835 |
| Magnesium Week 1 | -0.010 ± 0.0672 | -0.007 ± 0.0676 | 0.002 ± 0.0694 | -0.014 ± 0.0573 | -0.015 ± 0.0680 |
| Magnesium Week 2 | -0.004 ± 0.0795 | 0.008 ± 0.0745 | -0.011 ± 0.0771 | -0.019 ± 0.0624 | -0.007 ± 0.0680 |
| Magnesium Week 4 | -0.022 ± 0.0606 | 0.009 ± 0.0725 | -0.012 ± 0.0789 | -0.020 ± 0.0712 | -0.005 ± 0.0998 |
| Magnesium Week 8 | -0.016 ± 0.0706 | -0.008 ± 0.0593 | -0.013 ± 0.0819 | -0.015 ± 0.0706 | -0.006 ± 0.0624 |
| Magnesium Week 12 | 0.010 ± 0.0797 | 0.008 ± 0.0847 | -0.011 ± 0.0733 | -0.001 ± 0.0660 | 0.003 ± 0.0730 |
| Magnesium Week 16 | -0.002 ± 0.0742 | 0.003 ± 0.0823 | -0.021 ± 0.0659 | -0.009 ± 0.0629 | -0.002 ± 0.0731 |
| Magnesium Week 20 | -0.007 ± 0.0811 | -0.012 ± 0.0728 | -0.018 ± 0.0659 | -0.005 ± 0.0724 | -0.009 ± 0.0636 |
| Magnesium Week 24 | -0.005 ± 0.0757 | -0.004 ± 0.0572 | -0.014 ± 0.0732 | -0.009 ± 0.0559 | -0.016 ± 0.0664 |
| Magnesium Week 28 | -0.027 ± 0.0713 | -0.007 ± 0.0525 | -0.018 ± 0.0678 | -0.019 ± 0.0719 | -0.017 ± 0.0565 |
| Magnesium Week 32 | -0.023 ± 0.0727 | -0.016 ± 0.0641 | -0.016 ± 0.0603 | -0.012 ± 0.0670 | -0.013 ± 0.0572 |
| Magnesium Week 36 | -0.015 ± 0.0694 | -0.001 ± 0.0596 | -0.031 ± 0.0698 | -0.004 ± 0.0534 | -0.007 ± 0.0563 |
| Magnesium Week 40 | -0.032 ± 0.0681 | -0.007 ± 0.0541 | -0.014 ± 0.0754 | -0.024 ± 0.0636 | -0.009 ± 0.0684 |
| Magnesium Week 44 | -0.024 ± 0.0677 | -0.000 ± 0.0597 | -0.009 ± 0.0685 | -0.024 ± 0.0668 | -0.016 ± 0.0667 |
| Magnesium Week 48 | -0.004 ± 0.0633 | -0.004 ± 0.0546 | -0.014 ± 0.0569 | -0.006 ± 0.0616 | -0.009 ± 0.0648 |
| Potassium Week 1 | -0.095 ± 0.2701 | 0.089 ± 0.3608 | 0.081 ± 0.4289 | -0.017 ± 0.3098 | -0.062 ± 0.3216 |
| Potassium Week 2 | -0.098 ± 0.2975 | 0.085 ± 0.4095 | 0.002 ± 0.3327 | -0.005 ± 0.3521 | 0.027 ± 0.3074 |
| Potassium Week 4 | -0.080 ± 0.2522 | 0.008 ± 0.3821 | 0.026 ± 0.2632 | 0.024 ± 0.4030 | -0.063 ± 0.2853 |
| Potassium Week 8 | -0.056 ± 0.2907 | 0.069 ± 0.3221 | 0.014 ± 0.3306 | -0.010 ± 0.3135 | 0.000 ± 0.2520 |
| Potassium Week 12 | -0.073 ± 0.3217 | 0.033 ± 0.3398 | -0.024 ± 0.3192 | -0.082 ± 0.3074 | -0.080 ± 0.2977 |
| Potassium Week 16 | -0.086 ± 0.3258 | 0.083 ± 0.3112 | 0.012 ± 0.3651 | -0.037 ± 0.3035 | -0.020 ± 0.2713 |
| Potassium Week 20 | -0.092 ± 0.3846 | 0.031 ± 0.3381 | 0.055 ± 0.3494 | -0.019 ± 0.3627 | 0.000 ± 0.2774 |
| Potassium Week 24 | -0.095 ± 0.3308 | -0.072 ± 0.3052 | 0.030 ± 0.3844 | -0.094 ± 0.3414 | -0.062 ± 0.2967 |
| Potassium Week 28 | -0.077 ± 0.3141 | 0.105 ± 0.3616 | 0.063 ± 0.4265 | -0.003 ± 0.3312 | -0.030 ± 0.3480 |
| Potassium Week 32 | -0.062 ± 0.3306 | 0.069 ± 0.3621 | 0.023 ± 0.4154 | 0.056 ± 0.2688 | 0.046 ± 0.3094 |
| Potassium Week 36 | -0.092 ± 0.3388 | 0.045 ± 0.3689 | 0.066 ± 0.4316 | 0.003 ± 0.3205 | 0.033 ± 0.3359 |
| Potassium Week 40 | -0.092 ± 0.3616 | 0.089 ± 0.3826 | 0.024 ± 0.3484 | -0.003 ± 0.3407 | -0.017 ± 0.3456 |
| Potassium Week 44 | -0.119 ± 0.2933 | 0.029 ± 0.3571 | 0.068 ± 0.4344 | 0.094 ± 0.3084 | -0.035 ± 0.3009 |
| Potassium Week 48 | -0.137 ± 0.3627 | -0.053 ± 0.3244 | -0.032 ± 0.3274 | 0.003 ± 0.4123 | -0.027 ± 0.3250 |
| Sodium Week 1 | -0.146 ± 1.5582 | -0.184 ± 1.7531 | 0.000 ± 2.0471 | -0.610 ± 2.0722 | -0.375 ± 2.1326 |
| Sodium Week 2 | -0.500 ± 1.6417 | -0.513 ± 1.8191 | -0.209 ± 1.9341 | -0.244 ± 2.0221 | -0.341 ± 2.1167 |
| Sodium Week 4 | -0.732 ± 1.8442 | -0.385 ± 1.6482 | -0.214 ± 2.3430 | -0.707 ± 2.0155 | -0.805 ± 1.8196 |
| Sodium Week 8 | -0.854 ± 2.0070 | -0.410 ± 1.3711 | -0.860 ± 2.2316 | -0.359 ± 1.7394 | -0.463 ± 2.2924 |
| Sodium Week 12 | -0.512 ± 1.8858 | -0.513 ± 1.4845 | -0.619 ± 2.0357 | -0.632 ± 2.1738 | -0.854 ± 2.3512 |
| Sodium Week 16 | -0.738 ± 1.8086 | -0.211 ± 1.7423 | -0.714 ± 1.7708 | -0.842 ± 2.3656 | -0.780 ± 1.7250 |
| Sodium Week 20 | -0.675 ± 1.7155 | -0.538 ± 1.4482 | -0.857 ± 2.1928 | -0.595 ± 2.1661 | -0.775 ± 1.9147 |
| Sodium Week 24 | -0.821 ± 1.7751 | -0.487 ± 1.5196 | -0.463 ± 2.0137 | -0.472 ± 1.8124 | -0.725 ± 1.7393 |
| Sodium Week 28 | -0.462 ± 2.2924 | -0.658 ± 1.8494 | -0.683 ± 1.8767 | -0.457 ± 2.3307 | -0.575 ± 2.5609 |
| Sodium Week 32 | -1.077 ± 1.8692 | -0.128 ± 1.9219 | -0.525 ± 1.8809 | -0.441 ± 1.6732 | -0.667 ± 1.8257 |
| Sodium Week 36 | -0.711 ± 2.0122 | -0.263 ± 1.8986 | -0.512 ± 1.8725 | -0.618 ± 1.9850 | -0.436 ± 2.2337 |
| Sodium Week 40 | -0.432 ± 2.1153 | -0.474 ± 1.6397 | -0.512 ± 2.1578 | -0.882 ± 1.9812 | -0.950 ± 2.0248 |
| Sodium Week 44 | -0.486 ± 1.8352 | -0.737 ± 2.0492 | -0.878 ± 1.9390 | -0.647 ± 1.8238 | -1.000 ± 2.4179 |
| Sodium Week 48 | -0.237 ± 1.7772 | -0.763 ± 1.8074 | -0.732 ± 1.8845 | -0.706 ± 1.5281 | -0.750 ± 2.1334 |
Urea nitrogen was measured in millimoles per liter (mmol/L).
| mmol/L | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -0.093 ± 1.0815 | 0.126 ± 1.2116 | -0.123 ± 1.0989 | -0.012 ± 1.0900 | 0.173 ± 1.5513 |
| Week 2 | 0.386 ± 1.8183 | -0.208 ± 1.1329 | -0.047 ± 1.0359 | 0.024 ± 1.1762 | 0.212 ± 1.3064 |
| Week 4 | 0.027 ± 1.3217 | 0.013 ± 1.1307 | 0.083 ± 1.1244 | -0.224 ± 1.1449 | 0.007 ± 1.2384 |
| Week 8 | 0.007 ± 0.9936 | 0.023 ± 1.1685 | -0.070 ± 1.1143 | -0.379 ± 1.2316 | 0.080 ± 1.1265 |
| Week 12 | -0.166 ± 1.2654 | -0.244 ± 1.1740 | -0.231 ± 1.3357 | -0.429 ± 1.1733 | -0.151 ± 1.2426 |
| Week 16 | -0.133 ± 1.0656 | -0.087 ± 0.9793 | -0.200 ± 1.3083 | -0.218 ± 1.0747 | 0.012 ± 1.1996 |
| Week 20 | -0.207 ± 1.2670 | -0.490 ± 1.0901 | -0.064 ± 1.2916 | -0.357 ± 1.1572 | -0.035 ± 1.3202 |
| Week 24 | -0.256 ± 1.1378 | -0.523 ± 1.1235 | -0.232 ± 1.4951 | -0.289 ± 1.1369 | -0.138 ± 1.2245 |
| Week 28 | -0.267 ± 1.3487 | -0.287 ± 1.0992 | 0.012 ± 1.3020 | -0.263 ± 1.1835 | -0.082 ± 1.3239 |
| Week 32 | -0.097 ± 1.0396 | -0.141 ± 1.3098 | -0.200 ± 1.1266 | -0.326 ± 1.1199 | 0.082 ± 1.1841 |
| Week 36 | -0.203 ± 1.0579 | -0.308 ± 1.1757 | 0.015 ± 1.1094 | -0.247 ± 1.1683 | -0.018 ± 1.1014 |
| Week 40 | -0.214 ± 1.2537 | 0.192 ± 1.3690 | 0.068 ± 1.1230 | -0.132 ± 1.1834 | 0.283 ± 1.3435 |
| Week 44 | -0.105 ± 1.3389 | -0.047 ± 1.3456 | -0.054 ± 1.1276 | -0.229 ± 1.1979 | 0.210 ± 1.2264 |
| Week 48 | -0.111 ± 1.4431 | -0.113 ± 1.1796 | -0.222 ± 1.4085 | -0.285 ± 1.2611 | 0.088 ± 1.4580 |
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
| cells/HPF | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Erythrocytes Week 1 | -55.000 ± NA | 0.750 ± 0.9574 | 0.333 ± 0.5774 | 0.000 ± 0.0000 | 0.333 ± 0.5774 |
| Erythrocytes Week 2 | -54.000 ± NA | -0.500 ± 0.5774 | 0.250 ± 0.5000 | 0.000 ± 0.0000 | 1.333 ± 2.5166 |
| Erythrocytes Week 4 | 0.000 ± NA | 3.333 ± 5.7735 | 0.000 ± 0.7071 | 0.250 ± 0.5000 | -0.500 ± 0.7071 |
| Erythrocytes Week 8 | — | 0.000 ± 0.0000 | 0.000 ± 0.8165 | 0.000 ± 0.0000 | 0.000 ± 1.0000 |
| Erythrocytes Week 12 | -23.000 ± NA | 0.000 ± 0.0000 | 0.800 ± 1.3038 | 0.000 ± 0.0000 | -0.333 ± 0.5774 |
| Erythrocytes Week 16 | -55.000 ± NA | 0.800 ± 1.7889 | 0.500 ± 1.7321 | 0.000 ± 0.0000 | 2.500 ± 3.5355 |
| Erythrocytes Week 20 | -30.000 ± 35.3553 | 0.000 ± 0.0000 | 0.400 ± 1.1402 | 0.000 ± 0.0000 | 0.250 ± 0.5000 |
| Erythrocytes Week 24 | — | -0.250 ± 0.5000 | 0.250 ± 0.5000 | -0.143 ± 0.8997 | 1.000 ± 2.6458 |
| Erythrocytes Week 28 | -5.000 ± NA | 0.000 ± 0.8165 | 0.400 ± 1.5166 | 0.000 ± 0.0000 | 2.333 ± 5.7735 |
| Erythrocytes Week 32 | -27.500 ± 38.8909 | 0.000 ± 0.0000 | 0.250 ± 0.5000 | 0.000 ± 0.0000 | 2.000 ± 3.4641 |
| Erythrocytes Week 36 | -55.000 ± NA | 0.000 ± 0.0000 | 0.250 ± 0.5000 | 0.000 ± NA | -1.000 ± NA |
| Erythrocytes Week 40 | — | -0.250 ± 0.5000 | 0.750 ± 1.5000 | -0.250 ± 0.5000 | 0.000 ± 0.0000 |
| Erythrocytes Week 44 | -55.000 ± NA | 0.000 ± 0.0000 | 0.400 ± 0.8944 | -0.250 ± 1.2583 | 0.000 ± 0.0000 |
| Erythrocytes Week 48 | -27.500 ± 38.8909 | 0.167 ± 0.4082 | 1.750 ± 3.5000 | 0.000 ± 0.0000 | 0.000 ± 0.8165 |
| Leukocytes Week 1 | 0.000 ± NA | 2.750 ± 6.1847 | -7.667 ± 13.2791 | -0.200 ± 1.0954 | 0.667 ± 1.1547 |
| Leukocytes Week 2 | 2.000 ± NA | -2.500 ± 2.0817 | -3.000 ± 6.6833 | -0.250 ± 0.5000 | 0.000 ± 0.0000 |
| Leukocytes Week 4 | 0.000 ± NA | 0.000 ± 0.0000 | -4.600 ± 10.2372 | 0.250 ± 0.5000 | 2.000 ± 2.8284 |
| Leukocytes Week 8 | — | 0.000 ± 0.0000 | -1.500 ± 3.6968 | 0.000 ± 0.0000 | 4.000 ± 6.9282 |
| Leukocytes Week 12 | 0.000 ± NA | 1.667 ± 4.7258 | 13.500 ± 26.3376 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Leukocytes Week 16 | 0.000 ± NA | -0.200 ± 1.7889 | 33.750 ± 67.5000 | -0.400 ± 0.8944 | 0.500 ± 0.7071 |
| Leukocytes Week 20 | 0.000 ± 2.8284 | 3.000 ± 6.0000 | 57.800 ± 145.4036 | 0.667 ± 1.5055 | -6.750 ± 14.8633 |
| Leukocytes Week 24 | — | 2.750 ± 4.8563 | -6.500 ± 13.0000 | 2.286 ± 4.8206 | 0.333 ± 0.5774 |
| Leukocytes Week 28 | -2.000 ± NA | -0.750 ± 0.9574 | -5.400 ± 12.0748 | 0.000 ± 0.0000 | 2.333 ± 4.0415 |
| Leukocytes Week 32 | 0.000 ± 0.0000 | 3.333 ± 5.7735 | -6.500 ± 13.0000 | -1.333 ± 1.6330 | 1.333 ± 2.3094 |
| Leukocytes Week 36 | 0.000 ± NA | 0.667 ± 2.7325 | 0.000 ± 0.0000 | 24.000 ± NA | 0.000 ± NA |
| Leukocytes Week 40 | — | -0.500 ± 2.5166 | -7.500 ± 15.0000 | 1.500 ± 3.0000 | 0.000 ± 0.0000 |
| Leukocytes Week 44 | 0.000 ± NA | 0.400 ± 0.8944 | -1.400 ± 3.1305 | -0.500 ± 1.0000 | 0.000 ± 0.0000 |
| Leukocytes Week 48 | 0.000 ± 0.0000 | 8.000 ± 21.6148 | 69.500 ± 139.0000 | -1.000 ± 1.7321 | 0.250 ± 0.5000 |
| Renal Epithelial Casts Week 1 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 2 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 4 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 8 | — | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 12 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 16 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 20 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 24 | — | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 28 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 32 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 36 | 0.000 ± NA | 0.167 ± 0.4082 | 0.000 ± 0.0000 | 0.000 ± NA | 0.000 ± NA |
| Renal Epithelial Casts Week 40 | — | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 44 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Renal Epithelial Casts Week 48 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Squamous Epithelial Cells Week 1 | 0.000 ± NA | 0.250 ± 1.2583 | 3.000 ± 5.1962 | -0.200 ± 0.4472 | -0.333 ± 0.5774 |
| Squamous Epithelial Cells Week 2 | 1.000 ± NA | -8.000 ± 14.6969 | -0.250 ± 3.6856 | 0.000 ± 0.0000 | -1.667 ± 1.5275 |
| Squamous Epithelial Cells Week 4 | 0.000 ± NA | 0.000 ± 0.0000 | -1.800 ± 7.1554 | 0.000 ± 0.0000 | 1.000 ± 1.4142 |
| Squamous Epithelial Cells Week 8 | — | 0.000 ± 0.0000 | 0.500 ± 1.0000 | 0.000 ± 0.0000 | 0.333 ± 0.5774 |
| Squamous Epithelial Cells Week 12 | 0.000 ± NA | -4.333 ± 7.5056 | -2.200 ± 5.4955 | 0.000 ± 0.0000 | 0.333 ± 0.5774 |
| Squamous Epithelial Cells Week 16 | 0.000 ± NA | 0.000 ± 0.0000 | -2.750 ± 5.5000 | -0.200 ± 0.4472 | 0.000 ± 0.0000 |
| Squamous Epithelial Cells Week 20 | 1.000 ± 1.4142 | -2.750 ± 5.5000 | -1.400 ± 5.6391 | -0.167 ± 0.9832 | -0.750 ± 0.9574 |
| Squamous Epithelial Cells Week 24 | — | 1.000 ± 1.4142 | 1.000 ± 2.0000 | -0.286 ± 0.4880 | 1.333 ± 4.1633 |
| Squamous Epithelial Cells Week 28 | 0.000 ± NA | -3.000 ± 6.0000 | 0.600 ± 1.3416 | -0.250 ± 0.5000 | -1.667 ± 1.5275 |
| Squamous Epithelial Cells Week 32 | 0.500 ± 0.7071 | 0.000 ± 0.0000 | 0.500 ± 1.0000 | -0.667 ± 0.8165 | -0.500 ± 0.7071 |
| Squamous Epithelial Cells Week 36 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± NA | 0.000 ± NA |
| Squamous Epithelial Cells Week 40 | — | -2.750 ± 5.5000 | 0.750 ± 1.5000 | 0.000 ± 0.0000 | -0.500 ± 0.7071 |
| Squamous Epithelial Cells Week 44 | 0.000 ± NA | -1.000 ± 2.2361 | 0.600 ± 1.3416 | -0.250 ± 0.5000 | -0.500 ± 0.7071 |
| Squamous Epithelial Cells Week 48 | 0.000 ± 0.0000 | 0.667 ± 1.6330 | 1.250 ± 1.8930 | 0.333 ± 0.5774 | -1.000 ± 1.0000 |
| Transitional Epithelial Cells Week 1 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 2 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 4 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 8 | — | 1.000 ± 1.7321 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 12 | 0.000 ± NA | 0.000 ± 0.0000 | 0.200 ± 0.4472 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 16 | 0.000 ± NA | 0.400 ± 0.8944 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 20 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 24 | — | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 28 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 32 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 36 | 0.000 ± NA | 0.167 ± 0.4082 | 0.000 ± 0.0000 | 0.000 ± NA | 0.000 ± NA |
| Transitional Epithelial Cells Week 40 | — | 0.250 ± 0.5000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 44 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Transitional Epithelial Cells Week 48 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
Hyaline casts was measured in cells per low power field (cells/LPF).
| cells/LPF | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | 0.000 ± NA | 0.000 ± 0.0000 | 1.000 ± 1.7321 | -0.200 ± 0.4472 | 0.000 ± 0.0000 |
| Week 2 | 0.000 ± NA | 0.250 ± 0.5000 | 1.000 ± 1.1547 | -0.250 ± 0.5000 | 0.333 ± 0.5774 |
| Week 4 | 0.000 ± NA | 0.000 ± 0.0000 | -0.800 ± 1.0954 | -0.250 ± 0.5000 | 0.000 ± 0.0000 |
| Week 8 | — | 0.333 ± 0.5774 | 0.250 ± 0.5000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Week 12 | 0.000 ± NA | 0.000 ± 0.0000 | 5.000 ± 11.1803 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Week 16 | 0.000 ± NA | 0.000 ± 0.0000 | 0.500 ± 1.0000 | 0.000 ± 0.0000 | 0.500 ± 0.7071 |
| Week 20 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | -0.600 ± 0.8944 | 1.500 ± 3.6742 | -0.750 ± 1.5000 |
| Week 24 | — | 0.000 ± 0.0000 | -0.250 ± 0.5000 | 0.857 ± 2.2678 | 0.333 ± 0.5774 |
| Week 28 | 0.000 ± NA | 0.000 ± 0.0000 | -0.400 ± 0.8944 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Week 32 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 1.250 ± 2.5000 | 0.000 ± 0.0000 | 13.333 ± 23.0940 |
| Week 36 | 0.000 ± NA | 0.000 ± 0.0000 | 0.000 ± 0.0000 | 0.000 ± NA | 0.000 ± NA |
| Week 40 | — | 0.000 ± 0.0000 | -0.500 ± 1.0000 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Week 44 | 0.000 ± NA | 0.400 ± 0.8944 | -0.400 ± 0.8944 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
| Week 48 | 0.000 ± 0.0000 | 1.167 ± 2.8577 | 0.000 ± 0.0000 | 0.000 ± 0.0000 | -0.250 ± 0.5000 |
Urine pH was measured on a pH scale.
| pH | Placebo (SS) | BKZ 16 mg (SS) | BKZ 160 mg (SS) | BKZ 160 mg LD (SS) | BKZ 320 mg (SS) |
|---|---|---|---|---|---|
| Week 1 | -0.138 ± 0.9198 | 0.197 ± 0.5875 | 0.023 ± 0.8014 | 0.085 ± 0.6011 | 0.000 ± 0.8321 |
| Week 2 | -0.155 ± 0.9072 | 0.154 ± 0.7708 | -0.081 ± 0.7149 | 0.134 ± 0.8293 | -0.012 ± 0.7541 |
| Week 4 | -0.195 ± 0.9211 | 0.026 ± 0.6571 | -0.134 ± 0.8368 | 0.063 ± 0.6620 | -0.098 ± 0.6729 |
| Week 8 | 0.000 ± 0.7826 | 0.077 ± 0.7393 | -0.024 ± 0.8762 | 0.263 ± 0.7235 | 0.024 ± 0.7579 |
| Week 12 | -0.100 ± 1.0203 | 0.237 ± 0.7600 | -0.047 ± 0.6971 | 0.211 ± 0.6641 | 0.073 ± 0.8843 |
| Week 16 | -0.107 ± 0.8449 | 0.092 ± 0.7957 | -0.122 ± 0.8199 | 0.118 ± 0.7207 | 0.088 ± 0.7240 |
| Week 20 | -0.113 ± 0.7884 | 0.269 ± 0.8649 | -0.012 ± 0.8300 | -0.054 ± 0.6539 | 0.063 ± 0.8929 |
| Week 24 | -0.154 ± 0.9400 | -0.013 ± 0.8011 | -0.085 ± 0.6605 | 0.100 ± 0.4820 | -0.026 ± 0.6973 |
| Week 28 | -0.090 ± 0.8419 | -0.053 ± 0.6657 | -0.122 ± 0.7313 | 0.086 ± 0.6122 | -0.088 ± 0.6783 |
| Week 32 | -0.218 ± 0.8335 | -0.079 ± 0.7491 | 0.063 ± 0.8784 | -0.103 ± 0.6717 | -0.269 ± 0.5718 |
| Week 36 | -0.211 ± 0.8353 | 0.118 ± 0.7300 | -0.195 ± 0.8506 | -0.118 ± 0.6038 | -0.077 ± 0.7569 |
| Week 40 | -0.216 ± 0.9394 | -0.041 ± 0.6388 | -0.188 ± 0.8525 | -0.191 ± 0.5643 | -0.154 ± 0.7448 |
| Week 44 | -0.458 ± 0.7780 | -0.171 ± 0.7002 | -0.159 ± 0.9044 | -0.167 ± 0.6693 | -0.171 ± 0.7285 |
| Week 48 | -0.092 ± 1.0771 | -0.014 ± 0.7318 | -0.200 ± 0.8533 | -0.015 ± 0.7855 | -0.100 ± 0.7528 |
Collected over Adverse events (AEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 68). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (SS) - up to Wk 12 | 0/42 (0%) | 1/42 (2.4%) | 8/42 (19%) |
| BKZ 16 mg (SS) - up to Wk 12 | 0/39 (0%) | 0/39 (0%) | 9/39 (23.1%) |
| BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | 0/126 (0%) | 8/126 (6.3%) | 40/126 (31.7%) |
| BKZ 320 mg (SS) - up to Wk 68 | 0/80 (0%) | 0/80 (0%) | 29/80 (36.3%) |
| Event | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | BKZ 320 mg (SS) - up to Wk 68 |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 1/42 | 0/39 | 0/126 | 0/80 |
| GoitreEndocrine disorders | 0/42 | 0/39 | 1/126 | 0/80 |
| Drug-induced liver injuryHepatobiliary disorders | 0/42 | 0/39 | 1/126 | 0/80 |
| CellulitisInfections and infestations | 0/42 | 0/39 | 1/126 | 0/80 |
| Otitis media chronicInfections and infestations | 0/42 | 0/39 | 1/126 | 0/80 |
| Hepatitis EInfections and infestations | 0/42 | 0/39 | 1/126 | 0/80 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/42 | 0/39 | 1/126 | 0/80 |
| Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/42 | 0/39 | 1/126 | 0/80 |
| Carpal tunnel syndromeNervous system disorders | 0/42 | 0/39 | 1/126 | 0/80 |
| Event | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 | BKZ 320 mg (SS) - up to Wk 68 |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/42 | 3/39 | 12/126 | 11/80 |
| Upper respiratory tract infectionInfections and infestations | 0/42 | 1/39 | 12/126 | 8/80 |
| HypertensionVascular disorders | 4/42 | 0/39 | 0/126 | 2/80 |
| PharyngitisInfections and infestations | 0/42 | 0/39 | 4/126 | 7/80 |
| Psoriatic arthropathyMusculoskeletal and connective tissue disorders | 3/42 | 2/39 | 2/126 | 1/80 |
| Respiratory tract infectionInfections and infestations | 0/42 | 2/39 | 8/126 | 2/80 |
| BronchitisInfections and infestations | 1/42 | 0/39 | 7/126 | 3/80 |
| Ear infectionInfections and infestations | 0/42 | 2/39 | 1/126 | 0/80 |
| InsomniaPsychiatric disorders | 0/42 | 2/39 | 0/126 | 3/80 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/42 | 2/39 | 0/126 | 1/80 |
The Baseline Characteristics refer to the Full Analysis Set (FAS), which consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
| Age, Categorical(Participants) | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 35 | 40 | 36 | 36 | 185 |
| >=65 years | 4 | 6 | 1 | 5 | 5 | 21 |
| Age, Continuous(years) | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Mean | 49.02 ± 12.07 | 49.98 ± 13.56 | 48.00 ± 11.65 | 49.05 ± 12.99 | 50.39 ± 12.08 | 49.29 ± 12.39 |
| Sex: Female, Male(Participants) | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Female | 18 | 17 | 21 | 27 | 18 | 101 |
| Male | 24 | 24 | 20 | 14 | 23 | 105 |
| Race/Ethnicity, Customized(Participants) | Placebo | BKZ 16 mg | BKZ 160 mg | BKZ 160 mg LD | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Asian | 1 | 0 | 0 | 0 | 0 | 1 |
| Black | 1 | 1 | 2 | 1 | 0 | 5 |
| White | 40 | 40 | 39 | 40 | 41 | 200 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2016 to primary completion in Nov 2017, 13 months.
Results were first posted in Nov 2020, 3 years after primary completion. A results delay was requested in Nov 2018.
Of 34 phase 2 interventional studies under Arthritis, Psoriatic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bimekizumab