A Phase 2 interventional study of Bimekizumab and Placebo in Chronic Plaque Psoriasis, sponsored by UCB Biopharma S.P.R.L.. Completed at 41 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by UCB Biopharma S.P.R.L. · Phase 2, Interventional, and Treatment
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 250 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →UCB Biopharma S.P.R.L. is the lead sponsor of 46 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.
Exclusion Criteria:
Other: Placebo
Drug: Bimekizumab · Other: Placebo
Drug: Bimekizumab · Other: Placebo
Drug: Bimekizumab · Other: Placebo
Drug: Bimekizumab · Other: Placebo
Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Also known as: UCB4940
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
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
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time frame: Week 12
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time frame: Week 8
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
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 8
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
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 Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Time frame: Week 12
Plasma Concentrations of Bimekizumab During the Study
Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Antibody positive status prior study treatment was defined as having an antibody level greater than (\>) 28.5% at Baseline (Week 0).
Time frame: Baseline (Week 0)
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Overall antibody positive was defined as having a value of \> 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
Time frame: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
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 to End of Safety Follow-up (up to Week 32)
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
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 to End of Safety Follow-up (up to Week 32)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Platelets was measured in number of platelets per liter (10\^9/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (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 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
C Reactive Protein was measured in milligrams per liters (mg/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Urine pH was measured on a pH scale.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Blood pressure was measured in millimeters of mercury (mmHg).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
Temperature was measured in degrees Celsius (°C).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Percentage of Participants With Clinically Significant Physical Examination Abnormalities
The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.
Time frame: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
The study started to enroll participants in August 2016 and concluded in July 2017.
| Milestone | Placebo | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W |
|---|---|---|---|---|---|---|
| Started | 42 | 39 | 43 | 40 | 43 | 43 |
| Completed treatment period | 37 | 36 | 38 | 34 | 40 | 39 |
| Enrolled in extension study (ps0011) | 38 | 35 | 39 | 38 | 42 | 40 |
| Entered safety follow-up period | 4 | 4 | 4 | 2 | 1 | 3 |
| Completed | 37 | 36 | 38 | 34 | 40 | 39 |
| Not completed | 5 | 3 | 5 | 6 | 3 | 4 |
| Withdrew: Adverse event | 1 | 1 | 1 | 1 | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Screening exclusion criteria met | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lab withdrawal criterion met | 0 | 1 | 2 | 2 | 2 | 1 |
| Withdrew: Positive for tuberculosis | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Subject positive for hep b | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Patient moved abroad | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Patient randomized by mistake | 0 | 0 | 0 | 0 | 0 | 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.
| percentage of participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 0 | 46.2 | 67.4 | 75.0 | 79.1 | 72.1 |
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
| percentage of participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 4.8 | 51.3 | 74.4 | 75.0 | 86.0 | 76.7 |
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
| percentage of participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 4.8 | 46.2 | 62.8 | 77.5 | 86.0 | 72.1 |
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.
| percentage of participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 0 | 41.0 | 58.1 | 67.5 | 86.0 | 69.8 |
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 participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 4.8 | 61.5 | 81.4 | 85.0 | 93.0 | 83.7 |
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
| percentage of participants | Placebo (FAS) | Bimekizumab 64 mg Q4W (FAS) | Bimekizumab 160 mg Q4W (FAS) | Bimekizumab 160 mg w/ LD Q4W (FAS) | Bimekizumab 320 mg Q4W (FAS) | Bimekizumab 480 mg Q4W (FAS) |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 0 | 28.2 | 27.9 | 60.0 | 55.8 | 48.8 |
Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
| µg/mL | Bimekizumab 64 mg Q4W (PK-PPS) | Bimekizumab 160 mg Q4W (PK-PPS) | Bimekizumab 160 mg w/ LD Q4W (PK-PPS) | Bimekizumab 320 mg Q4W (PK-PPS) | Bimekizumab 480 mg Q4W (PK-PPS) |
|---|---|---|---|---|---|
| Baseline | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| Week 1 | 4.4490 (3.7526 to 5.2746) | 9.2481 (6.9779 to 12.2569) | 20.7892 (14.9192 to 28.9688) | 21.8622 (16.0624 to 29.7563) | 31.8019 (23.3488 to 43.3154) |
| Week 2 | 3.4704 (3.0167 to 3.9923) | 8.6862 (7.5316 to 10.0179) | 19.0428 (16.5381 to 21.9267) | 19.0324 (16.8925 to 21.4434) | 27.5641 (23.8485 to 31.8586) |
| Week 4 | 2.1282 (1.8398 to 2.4617) | 5.3751 (4.5233 to 6.3872) | 11.2903 (9.4809 to 13.4450) | 11.9194 (10.4503 to 13.5951) | 17.1811 (14.7612 to 19.9977) |
| Week 8 | 2.3069 (1.7780 to 2.9931) | 7.1859 (5.3747 to 9.6075) | 10.2208 (8.8561 to 11.7957) | 16.3187 (13.9947 to 19.0285) | 23.3285 (19.8863 to 27.3665) |
| Week 12 | 2.3121 (1.6037 to 3.3335) | 9.5278 (8.0614 to 11.2608) | 10.2557 (8.6807 to 12.1165) | 18.3166 (15.1652 to 22.1228) | 28.0908 (23.2463 to 33.9448) |
| SFU | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 0.5165 (0.0032 to 84.5222) |
The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
| L/Day | All Participants (PK-PPS) |
|---|---|
| Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab | 0.362 ± 41.7 |
The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
| liters | All Participants (PK-PPS) |
|---|---|
| Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab | 11.5 ± 146 |
The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
| µg/mL | All Participants (PK-PPS) |
|---|---|
| Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) | 0.55 ± 126 |
Antibody positive status prior study treatment was defined as having an antibody level greater than (\>) 28.5% at Baseline (Week 0).
| percentage of participants | Placebo (PK-PPS) | Bimekizumab 64 mg Q4W (PK-PPS) | Bimekizumab 160 mg Q4W (PK-PPS) | Bimekizumab 160 mg w/ LD Q4W (PK-PPS) | Bimekizumab 320 mg Q4W (PK-PPS) | Bimekizumab 480 mg Q4W (PK-PPS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 | 0 | 0 | 2.5 | 0 | 0 |
Overall antibody positive was defined as having a value of \> 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
| percentage of participants | Placebo (PK-PPS) | Bimekizumab 64 mg Q4W (PK-PPS) | Bimekizumab 160 mg Q4W (PK-PPS) | Bimekizumab 160 mg w/ LD Q4W (PK-PPS) | Bimekizumab 320 mg Q4W (PK-PPS) | Bimekizumab 480 mg Q4W (PK-PPS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 0 | 10.3 | 4.8 | 5.0 | 0 | 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) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | 38.1 | 76.9 | 55.8 | 65.0 | 60.5 | 60.5 |
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) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Mild | 11.9 | 43.6 | 27.9 | 22.5 | 39.5 | 44.2 |
| Moderate | 26.2 | 30.8 | 27.9 | 40.0 | 20.9 | 11.6 |
| Severe | 0 | 2.6 | 0 | 2.5 | 0 | 4.7 |
Platelets was measured in number of platelets per liter (10\^9/L).
| 10^9 platelets per liter | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | 12.1 ± 34.7 | 3.2 ± 21.0 | -4.6 ± 30.8 | -14.0 ± 30.8 | 3.5 ± 25.2 | -0.1 ± 35.0 |
| Week 2 | 6.4 ± 37.8 | -8.6 ± 26.8 | -5.6 ± 36.4 | -8.9 ± 27.8 | 7.8 ± 31.2 | -3.9 ± 41.8 |
| Week 4 | -0.1 ± 32.0 | -5.8 ± 28.3 | -8.6 ± 40.1 | -11.4 ± 21.8 | -7.0 ± 28.9 | -7.5 ± 36.8 |
| Week 6 | 5.6 ± 47.5 | -5.2 ± 26.3 | -13.6 ± 34.3 | -5.6 ± 30.3 | -0.3 ± 44.0 | -7.6 ± 37.3 |
| Week 8 | 6.9 ± 37.6 | -2.3 ± 44.7 | -6.1 ± 43.7 | 6.3 ± 35.6 | 0.7 ± 39.5 | -4.7 ± 36.4 |
| Week 12 | 2.8 ± 36.7 | -6.0 ± 36.2 | -13.2 ± 40.1 | -3.6 ± 37.5 | -5.4 ± 36.1 | -5.5 ± 38.8 |
| SFU | 14.8 ± 33.3 | -30.3 ± 71.6 | 7.8 ± 20.0 | -33.0 ± 31.1 | 39.0 ± NA | 39.3 ± 27.4 |
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
| g/L | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Ery. mean corpuscular HGB Week 1 | 0.1 ± 8.1 | -2.0 ± 10.3 | -0.3 ± 8.8 | -1.0 ± 11.6 | 0.5 ± 8.6 | 0.3 ± 8.1 |
| Ery. mean corpuscular HGB Week 2 | 0.1 ± 7.9 | 1.1 ± 6.6 | 1.6 ± 9.4 | -0.3 ± 9.8 | 2.6 ± 7.9 | 1.8 ± 8.8 |
| Ery. mean corpuscular HGB Week 4 | -0.2 ± 9.1 | 0.2 ± 8.3 | -0.1 ± 9.9 | -2.9 ± 6.3 | 0.1 ± 8.0 | -0.4 ± 11.7 |
| Ery. mean corpuscular HGB Week 6 | -2.5 ± 11.0 | -1.7 ± 8.6 | -0.5 ± 9.4 | -2.9 ± 7.0 | -0.5 ± 7.8 | -1.3 ± 8.9 |
| Ery. mean corpuscular HGB Week 8 | -2.2 ± 8.0 | -1.4 ± 12.7 | 0.3 ± 10.3 | -2.5 ± 7.9 | -2.1 ± 9.2 | -2.9 ± 9.2 |
| Ery. mean corpuscular HGB Week 12 | -6.3 ± 12.5 | -2.2 ± 14.7 | -1.6 ± 9.1 | -4.5 ± 10.1 | -2.0 ± 12.7 | -3.6 ± 13.7 |
| Ery. mean corpuscular HGB SFU | -12.5 ± 11.0 | 5.3 ± 26.2 | -5.5 ± 10.6 | -9.5 ± 7.8 | -2.0 ± NA | -22.0 ± 18.0 |
| Hemoglobin Week 1 | -2.9 ± 7.3 | 0.1 ± 6.1 | 1.0 ± 6.8 | -2.6 ± 5.2 | -1.0 ± 7.0 | -0.8 ± 5.0 |
| Hemoglobin Week 2 | -3.0 ± 6.7 | 0.5 ± 5.3 | 0.6 ± 6.0 | -1.5 ± 7.5 | -1.1 ± 7.0 | 0.5 ± 6.6 |
| Hemoglobin Week 4 | -2.9 ± 8.2 | 0.8 ± 6.1 | -0.9 ± 6.2 | -2.1 ± 5.9 | -1.8 ± 8.7 | -0.4 ± 6.3 |
| Hemoglobin Week 6 | -2.4 ± 7.8 | 0.7 ± 6.3 | -0.3 ± 6.6 | -1.2 ± 4.8 | -2.1 ± 8.4 | 0.9 ± 6.3 |
| Hemoglobin Week 8 | -2.7 ± 8.0 | 1.1 ± 7.6 | 0.8 ± 7.1 | -0.6 ± 7.5 | -1.8 ± 8.1 | 0.9 ± 6.5 |
| Hemoglobin Week 12 | -1.8 ± 9.1 | 3.2 ± 9.6 | -0.1 ± 8.1 | -1.0 ± 8.5 | -1.2 ± 9.3 | 0.3 ± 7.1 |
| Hemoglobin SFU | -4.8 ± 7.4 | 7.8 ± 31.0 | -6.5 ± 4.7 | -8.5 ± 2.1 | 6.0 ± NA | -6.7 ± 11.0 |
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
| picograms (pg) | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -0.09 ± 0.57 | -0.01 ± 0.56 | -0.10 ± 0.55 | 0.07 ± 0.51 | -0.09 ± 0.87 | 0.00 ± 0.53 |
| Week 2 | -0.04 ± 0.59 | 0.04 ± 0.54 | 0.05 ± 0.49 | 0.10 ± 0.78 | -0.03 ± 0.60 | 0.14 ± 0.54 |
| Week 4 | -0.07 ± 0.66 | 0.10 ± 0.84 | -0.07 ± 0.63 | -0.01 ± 0.42 | -0.10 ± 0.68 | 0.04 ± 0.50 |
| Week 6 | -0.17 ± 0.64 | -0.09 ± 0.84 | -0.16 ± 0.61 | -0.11 ± 0.47 | -0.12 ± 0.84 | -0.04 ± 0.60 |
| Week 8 | -0.19 ± 0.64 | 0.09 ± 1.09 | -0.16 ± 1.10 | -0.16 ± 0.64 | -0.26 ± 0.99 | -0.16 ± 0.53 |
| Week 12 | -0.34 ± 0.71 | 0.09 ± 1.53 | -0.08 ± 0.58 | -0.14 ± 0.66 | -0.09 ± 1.14 | -0.16 ± 0.67 |
| SFU | -0.33 ± 0.79 | 2.93 ± 6.66 | -0.15 ± 0.17 | -0.55 ± 0.78 | 0.70 ± NA | -0.60 ± 1.10 |
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
| femtolitres (fL) | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -0.35 ± 1.55 | 0.52 ± 2.29 | -0.25 ± 1.64 | 0.51 ± 2.63 | -0.23 ± 2.14 | -0.04 ± 1.37 |
| Week 2 | -0.14 ± 1.65 | -0.16 ± 1.31 | -0.33 ± 1.96 | 0.31 ± 1.32 | -0.64 ± 1.40 | -0.05 ± 1.60 |
| Week 4 | -0.11 ± 1.60 | 0.23 ± 1.89 | -0.25 ± 1.81 | 0.67 ± 1.76 | -0.10 ± 1.64 | 0.22 ± 2.87 |
| Week 6 | 0.20 ± 2.84 | 0.14 ± 2.47 | -0.29 ± 1.90 | 0.39 ± 1.79 | -0.02 ± 1.92 | 0.25 ± 1.85 |
| Week 8 | 0.05 ± 2.11 | 0.71 ± 2.88 | -0.54 ± 2.57 | 0.16 ± 2.57 | -0.02 ± 2.29 | 0.36 ± 2.37 |
| Week 12 | 0.76 ± 3.81 | 0.87 ± 3.23 | 0.17 ± 2.39 | 0.78 ± 2.55 | 0.47 ± 2.88 | 0.51 ± 3.89 |
| SFU | 2.58 ± 5.10 | 7.80 ± 14.07 | 0.90 ± 2.38 | 0.85 ± 0.35 | 2.80 ± NA | 4.87 ± 8.46 |
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
| 10^12 red blood cells per liter | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -0.081 ± 0.282 | 0.004 ± 0.213 | 0.047 ± 0.238 | -0.095 ± 0.184 | -0.029 ± 0.259 | -0.026 ± 0.178 |
| Week 2 | -0.088 ± 0.220 | 0.010 ± 0.193 | 0.014 ± 0.215 | -0.060 ± 0.282 | -0.041 ± 0.231 | -0.001 ± 0.232 |
| Week 4 | -0.085 ± 0.274 | 0.019 ± 0.217 | -0.018 ± 0.193 | -0.066 ± 0.215 | -0.053 ± 0.281 | -0.015 ± 0.216 |
| Week 6 | -0.053 ± 0.277 | 0.038 ± 0.218 | 0.011 ± 0.243 | -0.019 ± 0.145 | -0.060 ± 0.278 | 0.035 ± 0.224 |
| Week 8 | -0.062 ± 0.320 | 0.022 ± 0.245 | 0.048 ± 0.219 | 0.009 ± 0.224 | -0.028 ± 0.240 | 0.056 ± 0.238 |
| Week 12 | -0.007 ± 0.314 | 0.092 ± 0.258 | 0.011 ± 0.271 | -0.005 ± 0.297 | -0.036 ± 0.297 | 0.039 ± 0.228 |
| SFU | -0.090 ± 0.346 | -0.135 ± 0.184 | -0.195 ± 0.165 | -0.215 ± 0.035 | 0.080 ± NA | -0.123 ± 0.491 |
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
| volume % of red blood cells | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -0.88 ± 2.49 | 0.27 ± 2.07 | 0.33 ± 2.31 | -0.58 ± 2.14 | -0.36 ± 2.31 | -0.23 ± 1.62 |
| Week 2 | -0.86 ± 2.02 | 0.00 ± 1.65 | -0.04 ± 2.15 | -0.42 ± 2.61 | -0.65 ± 2.09 | -0.02 ± 2.03 |
| Week 4 | -0.81 ± 2.40 | 0.24 ± 2.07 | -0.26 ± 1.86 | -0.26 ± 1.80 | -0.48 ± 2.57 | -0.03 ± 2.02 |
| Week 6 | -0.33 ± 2.46 | 0.41 ± 1.88 | -0.04 ± 2.18 | 0.02 ± 1.73 | -0.51 ± 2.59 | 0.44 ± 1.90 |
| Week 8 | -0.52 ± 2.37 | 0.55 ± 2.51 | 0.18 ± 1.84 | 0.14 ± 2.61 | -0.22 ± 2.46 | 0.67 ± 2.03 |
| Week 12 | 0.32 ± 2.87 | 1.25 ± 2.29 | 0.18 ± 2.57 | 0.30 ± 2.99 | -0.05 ± 2.75 | 0.59 ± 2.02 |
| SFU | 0.20 ± 1.44 | 1.98 ± 6.92 | -1.20 ± 1.90 | -1.50 ± 0.14 | 2.10 ± NA | 1.00 ± 0.85 |
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L).
| 10^9 white blood cells per liter | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Basophils Week 1 | 0.01 ± 0.03 | 0.01 ± 0.03 | 0.00 ± 0.03 | 0.01 ± 0.03 | 0.00 ± 0.04 | 0.01 ± 0.03 |
| Basophils Week 2 | 0.00 ± 0.02 | 0.00 ± 0.04 | 0.01 ± 0.04 | 0.01 ± 0.04 | 0.01 ± 0.04 | 0.00 ± 0.03 |
| Basophils Week 4 | 0.00 ± 0.03 | 0.00 ± 0.05 | 0.00 ± 0.03 | 0.01 ± 0.02 | 0.01 ± 0.05 | 0.00 ± 0.04 |
| Basophils Week 6 | 0.01 ± 0.03 | 0.00 ± 0.04 | 0.00 ± 0.04 | 0.01 ± 0.02 | 0.00 ± 0.04 | 0.00 ± 0.04 |
| Basophils Week 8 | 0.00 ± 0.04 | -0.01 ± 0.04 | 0.02 ± 0.01 | 0.00 ± 0.00 | 0.02 ± 0.04 | 0.00 ± 0.05 |
| Basophils Week 12 | 0.00 ± 0.03 | 0.00 ± 0.04 | 0.01 ± 0.03 | 0.00 ± 0.02 | 0.01 ± 0.04 | 0.00 ± 0.04 |
| Basophils SFU | 0.03 ± 0.05 | -0.03 ± 0.05 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± NA | 0.03 ± 0.06 |
| Eosinophils Week 1 | 0.02 ± 0.06 | 0.02 ± 0.12 | 0.01 ± 0.07 | 0.04 ± 0.10 | 0.02 ± 0.11 | -0.02 ± 0.12 |
| Eosinophils Week 2 | 0.02 ± 0.08 | 0.04 ± 0.26 | 0.00 ± 0.08 | 0.05 ± 0.11 | 0.00 ± 0.11 | 0.01 ± 0.11 |
| Eosinophils Week 4 | 0.03 ± 0.09 | 0.04 ± 0.26 | 0.01 ± 0.08 | 0.02 ± 0.11 | 0.03 ± 0.09 | 0.00 ± 0.18 |
| Eosinophils Week 6 | 0.04 ± 0.10 | 0.02 ± 0.19 | 0.00 ± 0.08 | 0.01 ± 0.09 | 0.05 ± 0.16 | -0.01 ± 0.17 |
| Eosinophils Week 8 | 0.01 ± 0.09 | 0.01 ± 0.18 | 0.01 ± 0.08 | 0.04 ± 0.17 | 0.05 ± 0.18 | -0.03 ± 0.16 |
| Eosinophils Week 12 | 0.02 ± 0.09 | 0.03 ± 0.22 | 0.00 ± 0.09 | 0.00 ± 0.08 | 0.03 ± 0.13 | -0.03 ± 0.11 |
| Eosinophils SFU | 0.05 ± 0.06 | 0.08 ± 0.10 | 0.10 ± 0.00 | 0.00 ± 0.00 | -0.10 ± NA | 0.07 ± 0.06 |
| Leukocytes Week 1 | 0.16 ± 1.30 | -0.59 ± 1.34 | -0.15 ± 1.43 | -0.63 ± 1.82 | -0.19 ± 1.51 | -0.48 ± 0.90 |
| Leukocytes Week 2 | 0.18 ± 1.36 | -0.56 ± 1.31 | -0.22 ± 1.43 | -0.42 ± 1.34 | -0.31 ± 1.80 | -0.46 ± 1.29 |
| Leukocytes Week 4 | 0.17 ± 1.51 | -0.36 ± 1.31 | -0.23 ± 1.38 | -0.54 ± 1.14 | -0.36 ± 1.73 | -0.34 ± 1.24 |
| Leukocytes Week 6 | -0.22 ± 1.25 | -0.50 ± 1.95 | -0.47 ± 1.49 | -0.57 ± 1.34 | -0.45 ± 2.02 | -0.45 ± 1.12 |
| Leukocytes Week 8 | -0.10 ± 1.34 | -0.67 ± 1.55 | -0.24 ± 1.94 | -0.37 ± 1.55 | -0.30 ± 1.76 | -0.45 ± 0.87 |
| Leukocytes Week 12 | 0.00 ± 1.37 | -0.28 ± 1.68 | -0.47 ± 1.67 | -0.51 ± 1.41 | -0.50 ± 1.44 | -0.48 ± 1.09 |
| Leukocytes SFU | -0.05 ± 0.98 | 1.15 ± 2.54 | 0.95 ± 1.43 | -0.65 ± 0.78 | 0.20 ± NA | 0.30 ± 0.40 |
| Lymphocytes Week 1 | 0.12 ± 0.36 | -0.05 ± 0.30 | 0.15 ± 0.42 | 0.13 ± 0.34 | 0.14 ± 0.46 | 0.00 ± 0.45 |
| Lymphocytes Week 2 | 0.08 ± 0.32 | -0.11 ± 0.30 | 0.09 ± 0.34 | 0.09 ± 0.40 | 0.12 ± 0.34 | -0.08 ± 0.37 |
| Lymphocytes Week 4 | 0.06 ± 0.40 | -0.04 ± 0.33 | 0.15 ± 0.43 | 0.08 ± 0.42 | 0.11 ± 0.36 | 0.06 ± 0.36 |
| Lymphocytes Week 6 | 0.08 ± 0.46 | -0.08 ± 0.43 | 0.03 ± 0.31 | 0.04 ± 0.43 | 0.05 ± 0.37 | -0.05 ± 0.40 |
| Lymphocytes Week 8 | 0.02 ± 0.37 | -0.04 ± 0.31 | 0.09 ± 0.40 | 0.11 ± 0.33 | 0.15 ± 0.45 | 0.06 ± 0.42 |
| Lymphocytes Week 12 | 0.08 ± 0.38 | 0.01 ± 0.35 | 0.06 ± 0.38 | 0.07 ± 0.48 | 0.14 ± 0.38 | -0.04 ± 0.37 |
| Lymphocytes SFU | 0.25 ± 0.24 | 0.25 ± 0.40 | 0.23 ± 0.19 | 0.25 ± 0.21 | 0.00 ± NA | 0.50 ± 0.44 |
| Monocytes Week 1 | 0.02 ± 0.16 | -0.01 ± 0.12 | 0.02 ± 0.15 | 0.02 ± 0.11 | 0.02 ± 0.17 | -0.03 ± 0.14 |
| Monocytes Week 2 | 0.00 ± 0.14 | -0.04 ± 0.13 | 0.00 ± 0.14 | 0.04 ± 0.15 | -0.04 ± 0.17 | -0.03 ± 0.15 |
| Monocytes Week 4 | 0.03 ± 0.16 | -0.01 ± 0.11 | 0.01 ± 0.15 | 0.03 ± 0.13 | -0.01 ± 0.17 | 0.02 ± 0.17 |
| Monocytes Week 6 | 0.01 ± 0.15 | -0.01 ± 0.18 | 0.02 ± 0.15 | 0.00 ± 0.11 | -0.02 ± 0.22 | -0.03 ± 0.18 |
| Monocytes Week 8 | -0.02 ± 0.15 | -0.03 ± 0.11 | 0.00 ± 0.16 | -0.01 ± 0.14 | -0.04 ± 0.17 | -0.02 ± 0.15 |
| Monocytes Week 12 | 0.01 ± 0.16 | 0.00 ± 0.14 | -0.02 ± 0.15 | -0.01 ± 0.18 | -0.07 ± 0.17 | -0.01 ± 0.14 |
| Monocytes SFU | 0.10 ± 0.22 | 0.10 ± 0.22 | 0.03 ± 0.10 | 0.00 ± 0.00 | -0.30 ± NA | -0.07 ± 0.21 |
| Neutrophils Week 1 | -0.02 ± 1.16 | -0.55 ± 1.12 | -0.32 ± 1.25 | -0.81 ± 1.81 | -0.37 ± 1.20 | -0.44 ± 0.76 |
| Neutrophils Week 2 | 0.09 ± 1.29 | -0.43 ± 1.05 | -0.31 ± 1.33 | -0.59 ± 1.09 | -0.41 ± 1.64 | -0.36 ± 1.13 |
| Neutrophils Week 4 | 0.04 ± 1.30 | -0.35 ± 1.07 | -0.39 ± 1.31 | -0.68 ± 1.02 | -0.48 ± 1.60 | -0.40 ± 1.18 |
| Neutrophils Week 6 | -0.36 ± 0.98 | -0.43 ± 1.64 | -0.49 ± 1.38 | -0.54 ± 1.16 | -0.50 ± 1.78 | -0.36 ± 1.01 |
| Neutrophils Week 8 | -0.13 ± 1.18 | -0.61 ± 1.40 | -0.34 ± 1.72 | -0.57 ± 1.28 | -0.45 ± 1.61 | -0.47 ± 0.80 |
| Neutrophils Week 12 | -0.11 ± 1.17 | -0.33 ± 1.50 | -0.49 ± 1.50 | -0.57 ± 1.20 | -0.59 ± 1.28 | -0.39 ± 0.93 |
| Neutrophils SFU | -0.45 ± 0.79 | 0.75 ± 1.88 | 0.65 ± 1.20 | -0.95 ± 0.49 | 0.50 ± NA | -0.13 ± 0.38 |
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
| mmol/L | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Calcium Week 1 | -0.010 ± 0.076 | 0.011 ± 0.088 | -0.021 ± 0.126 | -0.017 ± 0.076 | 0.000 ± 0.077 | -0.010 ± 0.080 |
| Calcium Week 2 | -0.003 ± 0.082 | 0.034 ± 0.094 | -0.007 ± 0.092 | 0.004 ± 0.074 | 0.006 ± 0.088 | -0.006 ± 0.085 |
| Calcium Week 4 | -0.029 ± 0.073 | 0.012 ± 0.099 | -0.020 ± 0.106 | -0.008 ± 0.074 | 0.005 ± 0.099 | -0.010 ± 0.084 |
| Calcium Week 6 | -0.033 ± 0.070 | 0.009 ± 0.079 | -0.019 ± 0.091 | -0.008 ± 0.092 | -0.026 ± 0.086 | -0.027 ± 0.100 |
| Calcium Week 8 | -0.023 ± 0.084 | 0.001 ± 0.106 | -0.027 ± 0.099 | 0.019 ± 0.089 | -0.002 ± 0.089 | -0.016 ± 0.084 |
| Calcium Week 12 | -0.011 ± 0.095 | 0.025 ± 0.092 | -0.038 ± 0.120 | 0.001 ± 0.093 | -0.019 ± 0.121 | -0.001 ± 0.092 |
| Calcium SFU | -0.095 ± 0.083 | -0.050 ± 0.109 | -0.073 ± 0.045 | -0.125 ± 0.134 | 0.020 ± NA | 0.020 ± 0.193 |
| Chloride Week 1 | 0.5 ± 1.8 | 0.6 ± 2.0 | 0.6 ± 2.3 | 0.6 ± 2.5 | 0.3 ± 2.1 | 0.1 ± 1.8 |
| Chloride Week 2 | 0.0 ± 2.3 | 0.1 ± 2.4 | -0.3 ± 2.2 | 0.4 ± 2.3 | 0.5 ± 2.1 | 0.1 ± 1.9 |
| Chloride Week 4 | 0.1 ± 1.8 | 0.8 ± 2.1 | 0.0 ± 2.5 | 0.2 ± 2.3 | -0.1 ± 2.6 | -0.1 ± 1.9 |
| Chloride Week 6 | -0.1 ± 2.1 | 0.0 ± 2.3 | -0.6 ± 1.7 | 0.0 ± 2.4 | -0.1 ± 3.0 | 0.1 ± 2.0 |
| Chloride Week 8 | 0.2 ± 2.1 | 0.3 ± 2.3 | 0.3 ± 2.0 | -0.1 ± 2.9 | 0.1 ± 2.4 | 0.1 ± 2.3 |
| Chloride Week 12 | 0.3 ± 1.7 | -0.1 ± 2.5 | -0.2 ± 2.0 | 0.2 ± 2.3 | 0.8 ± 2.4 | 0.1 ± 2.2 |
| Chloride SFU | 1.0 ± 1.6 | 3.0 ± 2.7 | 0.5 ± 5.4 | 2.0 ± 0.0 | 0.0 ± NA | 0.3 ± 2.1 |
| Potassium Week 1 | 0.08 ± 0.45 | 0.08 ± 0.33 | 0.05 ± 0.41 | 0.02 ± 0.36 | -0.03 ± 0.32 | 0.04 ± 0.29 |
| Potassium Week 2 | 0.03 ± 0.30 | 0.08 ± 0.33 | 0.02 ± 0.32 | -0.06 ± 0.29 | 0.05 ± 0.37 | -0.03 ± 0.39 |
| Potassium Week 4 | 0.09 ± 0.40 | 0.12 ± 0.41 | 0.09 ± 0.38 | 0.01 ± 0.34 | 0.05 ± 0.40 | 0.03 ± 0.33 |
| Potassium Week 6 | -0.04 ± 0.32 | 0.11 ± 0.35 | -0.03 ± 0.31 | -0.07 ± 0.33 | -0.07 ± 0.34 | -0.02 ± 0.35 |
| Potassium Week 8 | 0.01 ± 0.39 | 0.07 ± 0.36 | 0.12 ± 0.38 | -0.06 ± 0.38 | -0.12 ± 0.40 | 0.02 ± 0.35 |
| Potassium Week 12 | -0.05 ± 0.35 | 0.08 ± 0.34 | 0.08 ± 0.37 | -0.06 ± 0.37 | -0.07 ± 0.37 | -0.06 ± 0.33 |
| Potassium SFU | 0.10 ± 0.36 | 0.10 ± 0.37 | -0.10 ± 0.29 | -0.45 ± 0.07 | 0.20 ± NA | -0.20 ± 0.30 |
| Magnesium Week 1 | -0.010 ± 0.074 | -0.002 ± 0.052 | -0.020 ± 0.069 | 0.005 ± 0.079 | -0.007 ± 0.077 | -0.009 ± 0.064 |
| Magnesium Week 2 | -0.012 ± 0.063 | -0.004 ± 0.064 | -0.010 ± 0.065 | 0.001 ± 0.068 | -0.017 ± 0.086 | 0.005 ± 0.075 |
| Magnesium Week 4 | -0.023 ± 0.077 | -0.004 ± 0.062 | -0.017 ± 0.046 | 0.008 ± 0.071 | -0.017 ± 0.067 | -0.013 ± 0.070 |
| Magnesium Week 6 | -0.013 ± 0.054 | -0.014 ± 0.053 | -0.013 ± 0.057 | -0.008 ± 0.065 | -0.020 ± 0.073 | -0.017 ± 0.063 |
| Magnesium Week 8 | -0.026 ± 0.070 | -0.023 ± 0.042 | -0.023 ± 0.063 | 0.003 ± 0.071 | -0.019 ± 0.072 | -0.021 ± 0.058 |
| Magnesium Week 12 | -0.014 ± 0.093 | 0.007 ± 0.074 | -0.025 ± 0.069 | 0.009 ± 0.074 | -0.017 ± 0.075 | -0.008 ± 0.056 |
| Magnesium SFU | 0.053 ± 0.093 | 0.110 ± 0.295 | -0.035 ± 0.047 | -0.050 ± 0.057 | -0.060 ± NA | -0.023 ± 0.025 |
| Sodium Week 1 | -0.1 ± 1.8 | 0.2 ± 1.7 | 0.3 ± 2.7 | 0.1 ± 1.9 | 0.0 ± 2.2 | 0.0 ± 1.4 |
| Sodium Week 2 | -0.3 ± 1.7 | -0.2 ± 1.4 | -0.4 ± 1.8 | 0.0 ± 2.0 | 0.2 ± 2.3 | 0.0 ± 1.5 |
| Sodium Week 4 | -0.2 ± 1.7 | 0.2 ± 1.7 | 0.2 ± 1.7 | -0.2 ± 1.7 | -0.1 ± 2.3 | -0.2 ± 1.7 |
| Sodium Week 6 | -0.5 ± 2.0 | -0.1 ± 2.1 | -0.8 ± 1.6 | -0.1 ± 1.9 | -0.1 ± 2.9 | -0.3 ± 1.7 |
| Sodium Week 8 | -0.6 ± 2.0 | 0.0 ± 2.8 | -0.2 ± 1.8 | -0.2 ± 2.0 | -0.1 ± 2.2 | -0.6 ± 2.0 |
| Sodium Week 12 | -0.4 ± 2.0 | -0.2 ± 1.7 | -0.1 ± 1.7 | -0.2 ± 2.0 | -0.2 ± 2.4 | -0.3 ± 1.9 |
| Sodium SFU | -0.5 ± 2.1 | 0.8 ± 1.7 | -2.0 ± 2.2 | -2.0 ± 2.8 | -1.0 ± NA | -1.7 ± 1.2 |
| Urea Nitrogen Week 1 | -0.16 ± 1.09 | 0.11 ± 1.12 | 0.27 ± 1.19 | 0.34 ± 1.22 | 0.27 ± 1.24 | 0.21 ± 0.88 |
| Urea Nitrogen Week 2 | 0.00 ± 1.16 | -0.03 ± 1.25 | 0.24 ± 1.16 | 0.16 ± 1.17 | 0.27 ± 1.17 | 0.37 ± 1.03 |
| Urea Nitrogen Week 4 | -0.14 ± 1.16 | 0.48 ± 1.52 | 0.50 ± 1.31 | -0.03 ± 1.20 | -0.11 ± 1.08 | 0.15 ± 1.04 |
| Urea Nitrogen Week 6 | -0.12 ± 0.96 | 0.21 ± 1.40 | 0.41 ± 1.14 | 0.19 ± 1.31 | 0.29 ± 1.14 | 0.12 ± 0.93 |
| Urea Nitrogen Week 8 | -0.28 ± 1.29 | 0.14 ± 1.33 | 0.32 ± 1.08 | -0.08 ± 1.58 | 0.33 ± 1.30 | 0.35 ± 0.88 |
| Urea Nitrogen Week 12 | -0.17 ± 1.35 | -0.04 ± 1.37 | 0.39 ± 1.14 | 0.08 ± 1.13 | 0.13 ± 1.08 | 0.01 ± 0.85 |
| Urea Nitrogen SFU | 0.65 ± 1.74 | 0.80 ± 1.19 | 0.78 ± 3.27 | -0.65 ± 2.05 | -0.30 ± NA | 0.77 ± 1.27 |
| Cholesterol Week 1 | -0.04 ± 0.47 | -0.06 ± 0.54 | 0.00 ± 0.65 | -0.09 ± 0.59 | 0.12 ± 0.65 | 0.06 ± 0.34 |
| Cholesterol Week 2 | -0.13 ± 0.71 | 0.03 ± 0.63 | 0.12 ± 0.58 | -0.11 ± 0.52 | 0.12 ± 1.04 | 0.05 ± 0.57 |
| Cholesterol Week 4 | -0.06 ± 0.59 | 0.04 ± 0.63 | 0.17 ± 0.55 | -0.31 ± 0.88 | 0.00 ± 1.30 | 0.05 ± 0.66 |
| Cholesterol Week 6 | 0.05 ± 0.46 | -0.02 ± 0.73 | 0.17 ± 0.56 | -0.24 ± 0.70 | -0.24 ± 1.32 | 0.08 ± 0.60 |
| Cholesterol Week 8 | -0.08 ± 0.67 | -0.17 ± 0.68 | 0.16 ± 0.64 | -0.13 ± 0.83 | -0.17 ± 1.22 | 0.01 ± 0.48 |
| Cholesterol Week 12 | -0.20 ± 0.88 | -0.07 ± 0.62 | 0.11 ± 0.62 | -0.18 ± 0.77 | 0.01 ± 1.29 | -0.05 ± 0.76 |
| Cholesterol SFU | -0.28 ± 0.30 | -0.83 ± 1.56 | 0.38 ± 0.52 | -0.80 ± 0.14 | 0.20 ± NA | 0.40 ± 0.44 |
| Glucose Week 1 | 0.50 ± 1.59 | 0.12 ± 0.82 | -0.14 ± 1.00 | -0.06 ± 1.14 | 0.07 ± 1.10 | 0.22 ± 0.70 |
| Glucose Week 2 | 0.29 ± 1.62 | 0.17 ± 1.23 | -0.05 ± 0.92 | -0.20 ± 1.13 | 0.03 ± 1.09 | 0.05 ± 0.67 |
| Glucose Week 4 | 0.37 ± 1.42 | 0.25 ± 1.22 | -0.12 ± 1.03 | -0.09 ± 1.24 | 0.37 ± 1.20 | 0.19 ± 0.92 |
| Glucose Week 6 | 0.44 ± 1.42 | 0.30 ± 1.15 | -0.04 ± 1.26 | 0.02 ± 1.60 | 0.21 ± 1.30 | 0.29 ± 1.27 |
| Glucose Week 8 | 0.37 ± 1.48 | 0.22 ± 1.48 | -0.15 ± 0.87 | -0.06 ± 1.43 | 0.11 ± 1.10 | 0.03 ± 0.97 |
| Glucose Week 12 | 0.22 ± 1.27 | 0.01 ± 1.08 | 0.02 ± 1.35 | -0.17 ± 1.23 | -0.15 ± 0.88 | 0.04 ± 0.95 |
| Glucose SFU | -0.40 ± 0.48 | 0.75 ± 0.89 | -0.33 ± 0.67 | -0.25 ± 0.49 | 0.20 ± NA | -0.17 ± 0.61 |
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
| U/L | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Lactate Dehydrogenase Week 1 | -2.0 ± 29.4 | 1.1 ± 24.8 | -5.0 ± 24.1 | -0.3 ± 21.4 | -4.6 ± 18.9 | -3.4 ± 19.7 |
| Lactate Dehydrogenase Week 2 | -4.9 ± 26.4 | -2.5 ± 25.2 | -3.5 ± 22.1 | 0.4 ± 27.6 | -7.6 ± 27.4 | -5.1 ± 20.1 |
| Lactate Dehydrogenase Week 4 | -4.9 ± 22.4 | 1.7 ± 31.9 | -8.1 ± 16.7 | 5.0 ± 43.5 | -4.5 ± 37.7 | -4.4 ± 15.4 |
| Lactate Dehydrogenase Week 6 | -5.0 ± 27.7 | -1.4 ± 25.2 | -7.3 ± 20.3 | 2.0 ± 16.2 | -11.0 ± 27.5 | -3.5 ± 22.6 |
| Lactate Dehydrogenase Week 8 | -5.5 ± 27.4 | 0.5 ± 25.2 | -12.3 ± 22.2 | -0.8 ± 18.9 | -10.7 ± 33.1 | -3.7 ± 27.5 |
| Lactate Dehydrogenase Week 12 | -4.9 ± 28.1 | 2.9 ± 26.7 | -7.5 ± 25.1 | -0.3 ± 20.6 | -5.6 ± 33.1 | -4.4 ± 24.8 |
| Lactate Dehydrogenase SFU | -1.5 ± 12.9 | -5.0 ± 18.4 | 3.3 ± 81.2 | -45.5 ± 16.3 | 15.0 ± NA | 32.3 ± 34.2 |
| Alkaline Phosphatase Week 1 | -1.8 ± 6.3 | -0.5 ± 6.0 | -3.5 ± 8.2 | -3.8 ± 7.7 | -1.9 ± 5.3 | -2.3 ± 5.7 |
| Alkaline Phosphatase Week 2 | -3.0 ± 12.7 | 0.0 ± 7.4 | -2.5 ± 10.5 | -2.7 ± 8.2 | -1.6 ± 6.5 | -1.7 ± 7.7 |
| Alkaline Phosphatase Week 4 | -2.4 ± 8.7 | -1.9 ± 9.2 | -6.2 ± 9.8 | -4.3 ± 9.4 | -2.6 ± 8.1 | -1.7 ± 7.8 |
| Alkaline Phosphatase Week 6 | -3.0 ± 8.3 | -1.8 ± 9.0 | -5.5 ± 10.0 | -2.4 ± 8.6 | -2.1 ± 9.6 | -1.4 ± 7.5 |
| Alkaline Phosphatase Week 8 | -4.3 ± 12.2 | -1.7 ± 8.0 | -4.2 ± 11.2 | -2.1 ± 10.0 | -1.1 ± 11.3 | -1.9 ± 7.2 |
| Alkaline Phosphatase Week 12 | -2.0 ± 8.1 | 0.3 ± 7.2 | -2.4 ± 11.8 | -0.4 ± 9.0 | -0.5 ± 10.4 | -0.4 ± 8.4 |
| Alkaline Phosphatase SFU | -0.5 ± 7.4 | 9.8 ± 8.9 | 7.8 ± 15.3 | -3.0 ± 5.7 | 3.0 ± NA | 3.0 ± 1.0 |
| Alanine Aminotransferase Week 1 | 2.0 ± 7.7 | 2.1 ± 10.4 | -1.7 ± 13.7 | 1.6 ± 12.2 | 0.7 ± 8.9 | 1.2 ± 9.1 |
| Alanine Aminotransferase Week 2 | 0.3 ± 6.5 | 1.9 ± 9.0 | 2.0 ± 29.8 | -0.9 ± 7.7 | -0.2 ± 10.2 | 1.6 ± 11.5 |
| Alanine Aminotransferase Week 4 | -0.2 ± 7.0 | 1.1 ± 8.6 | 0.8 ± 18.7 | -0.4 ± 10.2 | 0.4 ± 14.7 | 1.0 ± 13.3 |
| Alanine Aminotransferase Week 6 | 3.9 ± 18.9 | 1.1 ± 8.9 | -0.6 ± 11.7 | 3.5 ± 20.9 | -1.7 ± 13.7 | 1.1 ± 12.5 |
| Alanine Aminotransferase Week 8 | 1.8 ± 10.8 | 2.2 ± 10.2 | 0.1 ± 10.5 | -0.4 ± 9.7 | -1.1 ± 14.5 | 0.8 ± 9.0 |
| Alanine Aminotransferase Week 12 | -1.3 ± 7.5 | 1.8 ± 9.9 | -1.0 ± 10.8 | -0.9 ± 9.1 | -0.9 ± 14.6 | -0.4 ± 10.6 |
| Alanine Aminotransferase SFU | -3.8 ± 3.0 | 4.3 ± 3.4 | 26.5 ± 42.1 | -6.0 ± 8.5 | 16.0 ± NA | -3.3 ± 3.1 |
| Aspartate Aminotransferase Week 1 | 0.5 ± 6.1 | 2.0 ± 10.8 | -3.0 ± 15.2 | 1.9 ± 11.5 | 0.3 ± 6.3 | -0.5 ± 7.2 |
| Aspartate Aminotransferase Week 2 | -1.0 ± 3.8 | 0.4 ± 4.9 | -1.9 ± 19.1 | -0.9 ± 4.7 | -0.5 ± 6.1 | 0.9 ± 13.4 |
| Aspartate Aminotransferase Week 4 | -1.1 ± 4.8 | -0.1 ± 5.8 | -2.5 ± 17.5 | -0.4 ± 5.9 | 0.6 ± 8.2 | -0.4 ± 7.5 |
| Aspartate Aminotransferase Week 6 | 1.5 ± 10.6 | 0.8 ± 6.0 | -0.9 ± 9.5 | 4.0 ± 15.7 | -1.4 ± 7.0 | -1.4 ± 6.5 |
| Aspartate Aminotransferase Week 8 | 0.0 ± 5.1 | 0.2 ± 6.7 | -1.4 ± 5.4 | -1.4 ± 4.6 | -0.4 ± 8.3 | -0.8 ± 6.3 |
| Aspartate Aminotransferase Week 12 | -1.3 ± 5.5 | 1.1 ± 7.9 | -1.4 ± 8.3 | -0.3 ± 4.8 | -0.5 ± 7.3 | -0.9 ± 5.2 |
| Aspartate Aminotransferase SFU | -2.8 ± 1.7 | -0.3 ± 2.1 | 11.5 ± 23.5 | -4.0 ± 2.8 | 9.0 ± NA | 0.7 ± 2.5 |
| Gamma Glutamyl Transferase Week 1 | 0.6 ± 6.4 | -0.8 ± 14.1 | -2.0 ± 10.7 | -7.5 ± 42.1 | 1.6 ± 22.9 | -0.8 ± 6.3 |
| Gamma Glutamyl Transferase Week 2 | 0.2 ± 8.7 | -1.6 ± 11.1 | 0.2 ± 14.2 | -1.2 ± 8.0 | -1.9 ± 6.5 | 0.4 ± 15.0 |
| Gamma Glutamyl Transferase Week 4 | -0.7 ± 8.5 | -1.9 ± 11.8 | 1.8 ± 18.6 | -2.6 ± 12.8 | -0.4 ± 8.4 | -1.4 ± 14.1 |
| Gamma Glutamyl Transferase Week 6 | 1.8 ± 10.5 | -1.8 ± 13.8 | -2.9 ± 13.1 | -2.9 ± 7.3 | -2.1 ± 9.3 | -1.1 ± 12.9 |
| Gamma Glutamyl Transferase Week 8 | 2.4 ± 13.7 | -1.9 ± 14.9 | -0.9 ± 18.4 | -2.6 ± 13.6 | -2.5 ± 9.4 | 3.1 ± 29.5 |
| Gamma Glutamyl Transferase Week 12 | -0.4 ± 10.9 | -2.2 ± 13.3 | -1.1 ± 21.7 | -0.6 ± 11.2 | -0.4 ± 11.1 | -0.9 ± 12.2 |
| Gamma Glutamyl Transferase SFU | -8.0 ± 13.4 | 1.3 ± 3.9 | 19.8 ± 23.3 | -16.5 ± 24.7 | 37.0 ± NA | 3.0 ± 3.5 |
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
| μmol/L | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Creatinine Week 1 | 0.6 ± 7.0 | 2.7 ± 10.1 | 1.4 ± 8.6 | 0.6 ± 8.1 | 0.7 ± 8.4 | -0.7 ± 7.7 |
| Creatinine Week 2 | 0.0 ± 7.1 | -0.8 ± 8.2 | -0.4 ± 10.1 | -0.7 ± 8.5 | -0.1 ± 8.3 | 0.0 ± 7.1 |
| Creatinine Week 4 | 0.0 ± 5.8 | 1.3 ± 9.1 | 0.6 ± 7.9 | -1.7 ± 8.1 | 0.6 ± 8.1 | 1.6 ± 7.2 |
| Creatinine Week 6 | -1.1 ± 7.8 | 1.6 ± 10.5 | -0.1 ± 10.6 | -0.6 ± 7.9 | -0.1 ± 8.1 | -0.5 ± 11.1 |
| Creatinine Week 8 | -1.1 ± 6.2 | -0.4 ± 7.4 | -1.0 ± 9.6 | -2.6 ± 8.4 | -0.1 ± 7.6 | 0.1 ± 8.3 |
| Creatinine Week 12 | -1.6 ± 7.8 | -0.2 ± 7.0 | 0.7 ± 12.0 | -0.7 ± 9.1 | 0.1 ± 9.0 | -0.7 ± 7.2 |
| Creatinine SFU | 1.5 ± 4.4 | 6.0 ± 4.3 | -6.5 ± 4.4 | -10.5 ± 16.3 | 9.0 ± NA | 1.3 ± 6.4 |
| Bilirubin Week 1 | -0.53 ± 3.10 | -1.79 ± 4.50 | -0.52 ± 2.81 | -0.55 ± 4.49 | 0.57 ± 5.73 | 0.14 ± 4.16 |
| Bilirubin Week 2 | -0.35 ± 2.85 | -0.86 ± 5.05 | -0.48 ± 3.40 | -0.38 ± 3.60 | -0.99 ± 2.98 | 0.27 ± 3.69 |
| Bilirubin Week 4 | -0.70 ± 3.26 | -1.70 ± 4.92 | -0.26 ± 3.53 | -0.04 ± 2.74 | 0.76 ± 4.27 | 0.70 ± 4.52 |
| Bilirubin Week 6 | -0.51 ± 3.13 | -1.15 ± 4.59 | 0.35 ± 3.44 | -0.33 ± 3.94 | 0.11 ± 4.19 | -0.30 ± 4.28 |
| Bilirubin Week 8 | -0.21 ± 3.81 | -0.98 ± 4.68 | -0.30 ± 3.20 | -0.43 ± 4.52 | -0.15 ± 3.79 | -0.02 ± 4.41 |
| Bilirubin Week 12 | -0.74 ± 3.43 | -1.02 ± 5.24 | -0.73 ± 2.98 | -1.20 ± 3.37 | -0.43 ± 3.68 | -0.34 ± 3.45 |
| Bilirubin SFU | 2.05 ± 2.16 | -1.23 ± 2.62 | -0.30 ± 3.87 | -0.25 ± 0.78 | -1.50 ± NA | 1.40 ± 2.96 |
C Reactive Protein was measured in milligrams per liters (mg/L).
| mg/L | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -2.110 ± 5.255 | -5.367 ± 11.806 | -0.775 ± 2.020 | -2.635 ± 2.550 | -5.108 ± 10.013 | -3.732 ± 3.997 |
| Week 2 | 1.821 ± 6.974 | -6.985 ± 11.064 | 0.576 ± 2.898 | 2.743 ± 15.212 | -6.763 ± 13.211 | -3.042 ± 1.989 |
| Week 4 | 1.338 ± 11.182 | -5.835 ± 8.594 | -1.722 ± 5.596 | 0.929 ± 8.047 | -4.226 ± 9.865 | 7.141 ± 32.344 |
| Week 6 | 2.978 ± 13.162 | -5.930 ± 9.560 | -4.516 ± 11.304 | -0.595 ± 7.346 | 1.799 ± 14.635 | -6.598 ± 6.278 |
| Week 8 | 3.153 ± 18.764 | -6.891 ± 15.192 | -3.143 ± 10.844 | 2.590 ± 7.755 | 12.434 ± 47.447 | -1.104 ± 5.201 |
| Week 12 | 7.279 ± 13.546 | -5.193 ± 10.817 | 0.695 ± 6.381 | -3.033 ± 7.261 | -9.890 ± 10.729 | -5.368 ± 5.322 |
| SFU | 8.000 ± NA | — | — | — | — | — |
Urine pH was measured on a pH scale.
| ph | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | 0.00 ± 0.79 | -0.10 ± 0.79 | -0.13 ± 0.88 | -0.20 ± 0.88 | -0.08 ± 0.82 | -0.07 ± 0.90 |
| Week 2 | 0.06 ± 0.86 | -0.06 ± 0.86 | -0.10 ± 0.77 | -0.23 ± 0.92 | -0.18 ± 0.76 | 0.06 ± 0.65 |
| Week 4 | 0.05 ± 0.87 | -0.09 ± 0.76 | -0.11 ± 0.95 | -0.26 ± 0.89 | -0.07 ± 0.73 | -0.04 ± 0.74 |
| Week 6 | -0.01 ± 0.73 | -0.03 ± 0.68 | -0.17 ± 0.69 | -0.18 ± 0.86 | -0.13 ± 0.81 | 0.05 ± 0.86 |
| Week 8 | -0.03 ± 0.92 | -0.07 ± 0.83 | -0.12 ± 1.07 | -0.34 ± 0.79 | -0.30 ± 0.91 | 0.08 ± 0.75 |
| Week 12 | -0.14 ± 0.79 | -0.01 ± 0.85 | 0.01 ± 0.70 | -0.28 ± 0.85 | -0.21 ± 0.99 | -0.01 ± 0.85 |
| SFU | 0.25 ± 1.04 | -0.25 ± 0.87 | 0.50 ± 1.22 | -1.00 ± 1.41 | 0.50 ± NA | -0.17 ± 0.29 |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline Low - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 High | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Normal | 84.6 | 84.2 | 97.3 | 88.2 | 90.0 | 92.3 |
| Baseline Normal - Week 12 High | 2.6 | 0 | 2.7 | 5.9 | 5.0 | 0 |
| Baseline High - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline High - Week 12 Normal | 7.7 | 15.8 | 0 | 2.9 | 5.0 | 7.7 |
| Baseline High - Week 12 High | 5.1 | 0 | 0 | 2.9 | 0 | 0 |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline Low - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 High | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Normal | 97.4 | 97.4 | 100 | 100 | 95.0 | 94.9 |
| Baseline Normal - Week 12 High | 0 | 2.6 | 0 | 0 | 2.5 | 2.6 |
| Baseline High - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline High - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 2.6 |
| Baseline High - Week 12 High | 2.6 | 0 | 0 | 0 | 2.5 | 0 |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline Low - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 High | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Normal | 76.9 | 86.8 | 83.8 | 79.4 | 77.5 | 89.7 |
| Baseline Normal - Week 12 High | 0 | 5.3 | 0 | 5.9 | 5.0 | 2.6 |
| Baseline High - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline High - Week 12 Normal | 10.3 | 5.3 | 5.4 | 8.8 | 15.0 | 5.1 |
| Baseline High - Week 12 High | 12.8 | 2.6 | 10.8 | 5.9 | 2.5 | 2.6 |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline Low - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 High | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Normal | 94.9 | 94.7 | 97.3 | 97.1 | 95.0 | 94.9 |
| Baseline Normal - Week 12 High | 0 | 2.6 | 2.7 | 2.9 | 0 | 0 |
| Baseline High - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline High - Week 12 Normal | 0 | 0 | 0 | 0 | 2.5 | 0 |
| Baseline High - Week 12 High | 5.1 | 2.6 | 0 | 0 | 2.5 | 5.1 |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline Low - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 Normal | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Low - Week 12 High | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline Normal - Week 12 Normal | 94.9 | 89.5 | 86.5 | 91.2 | 95.0 | 92.3 |
| Baseline Normal - Week 12 High | 0 | 7.9 | 2.7 | 2.9 | 2.5 | 0 |
| Baseline High - Week 12 Low | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline High - Week 12 Normal | 5.1 | 2.6 | 10.8 | 5.9 | 2.5 | 2.6 |
| Baseline High - Week 12 High | 0 | 0 | 0 | 0 | 0 | 5.1 |
Blood pressure was measured in millimeters of mercury (mmHg).
| mmHg | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Systolic Blood Pressure Week 1 | 1.2 ± 10.7 | 2.2 ± 7.1 | -3.9 ± 8.3 | 1.7 ± 9.3 | 0.2 ± 12.1 | -1.0 ± 9.9 |
| Systolic Blood Pressure Week 2 | -1.1 ± 9.7 | 2.1 ± 9.4 | -2.7 ± 12.5 | 0.2 ± 13.6 | -0.6 ± 8.4 | -3.2 ± 11.2 |
| Systolic Blood Pressure Week 4 | -2.3 ± 10.0 | 2.1 ± 7.9 | -1.9 ± 11.3 | 0.1 ± 12.4 | -0.1 ± 11.3 | -0.5 ± 10.8 |
| Systolic Blood Pressure Week 6 | -1.4 ± 9.8 | -1.3 ± 10.7 | -4.3 ± 10.6 | 0.1 ± 12.8 | -0.9 ± 10.9 | -2.4 ± 9.2 |
| Systolic Blood Pressure Week 8 | -0.8 ± 12.1 | -1.3 ± 13.0 | -3.4 ± 8.0 | 0.1 ± 12.3 | 0.5 ± 12.5 | -1.0 ± 10.7 |
| Systolic Blood Pressure Week 12 | -1.3 ± 10.9 | 2.2 ± 9.0 | -2.9 ± 10.3 | -0.3 ± 11.8 | -1.2 ± 10.4 | -2.4 ± 10.1 |
| Systolic Blood Pressure SFU | -7.0 ± 12.7 | -10.5 ± 17.0 | -1.3 ± 10.4 | 4.5 ± 7.8 | -2.0 ± NA | -2.0 ± 2.6 |
| Diastolic Blood Pressure Week 1 | -0.4 ± 7.4 | 0.9 ± 10.0 | -2.1 ± 7.3 | 0.6 ± 6.5 | 0.3 ± 7.4 | 0.1 ± 6.7 |
| Diastolic Blood Pressure Week 2 | -1.5 ± 6.9 | 0.4 ± 8.7 | -1.2 ± 7.1 | 2.1 ± 8.3 | 0.0 ± 7.2 | 0.2 ± 7.0 |
| Diastolic Blood Pressure Week 4 | -0.3 ± 7.8 | 0.6 ± 9.2 | -0.3 ± 7.9 | 0.6 ± 7.3 | 0.0 ± 7.7 | 0.3 ± 8.1 |
| Diastolic Blood Pressure Week 6 | 0.3 ± 7.6 | 0.0 ± 9.7 | -3.1 ± 7.9 | 1.3 ± 8.6 | 0.1 ± 7.3 | -1.6 ± 7.3 |
| Diastolic Blood Pressure Week 8 | -1.1 ± 8.9 | -0.3 ± 9.1 | -1.2 ± 7.3 | 2.8 ± 8.7 | -0.7 ± 7.7 | -0.6 ± 8.2 |
| Diastolic Blood Pressure Week 12 | -2.3 ± 5.8 | 0.5 ± 6.3 | -1.7 ± 6.4 | 3.1 ± 8.4 | -1.1 ± 6.7 | -1.1 ± 7.3 |
| Diastolic Blood Pressure SFU | 1.3 ± 8.5 | -9.0 ± 9.1 | 0.8 ± 8.8 | -4.5 ± 0.7 | -9.0 ± NA | -4.0 ± 6.6 |
Pulse rate was measured in beats per minute (beats/min).
| beats/min | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | 1.7 ± 9.5 | -1.6 ± 9.1 | 3.2 ± 8.0 | -1.8 ± 8.1 | 0.1 ± 6.4 | -0.4 ± 7.7 |
| Week 2 | 1.2 ± 8.4 | -1.3 ± 9.9 | 1.1 ± 7.8 | -1.0 ± 10.4 | -2.2 ± 7.9 | 0.5 ± 9.5 |
| Week 4 | 1.0 ± 10.2 | -3.1 ± 9.9 | 0.6 ± 7.8 | -3.6 ± 9.0 | -1.6 ± 6.5 | 1.6 ± 8.0 |
| Week 6 | 0.9 ± 9.8 | 1.2 ± 10.7 | 1.4 ± 8.3 | -2.6 ± 9.7 | -1.7 ± 9.3 | 2.6 ± 8.0 |
| Week 8 | 1.7 ± 8.9 | -3.2 ± 9.3 | 0.4 ± 9.2 | -1.8 ± 8.5 | 0.5 ± 8.2 | 0.6 ± 6.7 |
| Week 12 | 0.9 ± 8.4 | -1.9 ± 6.8 | 1.8 ± 11.0 | -3.1 ± 8.5 | -1.7 ± 9.1 | 0.0 ± 7.5 |
| SFU | -2.8 ± 2.6 | -2.5 ± 12.0 | 2.3 ± 6.0 | 1.5 ± 4.9 | -7.0 ± NA | 7.3 ± 3.2 |
Temperature was measured in degrees Celsius (°C).
| °C | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Week 1 | -0.07 ± 0.23 | -0.04 ± 0.22 | 0.02 ± 0.30 | -0.11 ± 0.32 | -0.07 ± 0.30 | 0.02 ± 0.35 |
| Week 2 | 0.00 ± 0.26 | 0.02 ± 0.26 | 0.01 ± 0.33 | 0.01 ± 0.35 | -0.04 ± 0.36 | -0.01 ± 0.35 |
| Week 4 | -0.05 ± 0.29 | 0.03 ± 0.24 | 0.00 ± 0.42 | -0.04 ± 0.24 | -0.03 ± 0.26 | -0.01 ± 0.41 |
| Week 6 | -0.03 ± 0.29 | -0.02 ± 0.25 | -0.01 ± 0.22 | -0.06 ± 0.43 | -0.03 ± 0.38 | 0.07 ± 0.24 |
| Week 8 | 0.01 ± 0.24 | -0.02 ± 0.28 | 0.00 ± 0.33 | -0.03 ± 0.41 | 0.00 ± 0.35 | 0.02 ± 0.31 |
| Week 12 | 0.10 ± 0.27 | 0.00 ± 0.27 | 0.06 ± 0.36 | -0.04 ± 0.28 | 0.00 ± 0.33 | 0.00 ± 0.30 |
| SFU | 0.08 ± 0.22 | 0.15 ± 0.33 | -0.03 ± 0.05 | 0.10 ± 0.00 | 0.10 ± NA | 0.43 ± 0.31 |
The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 23.8 | 7.7 | 11.6 | 10.0 | 9.3 | 0 |
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
| percentage of participants | Placebo (SS) | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 160 mg w/ LD Q4W (SS) | Bimekizumab 320 mg Q4W (SS) | Bimekizumab 480 mg Q4W (SS) |
|---|---|---|---|---|---|---|
| Baseline | 0 | 0 | 0 | 2.5 | 0 | 0 |
| Week 2 | 0 | 0 | 0 | 2.6 | 0 | 0 |
| Week 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 12 | 0 | 0 | 0 | 0 | 0 | 0 |
| SFU | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (SS) Treatment Period | 0/42 (0%) | 1/42 (2.4%) | 8/42 (19%) |
| Bimekizumab 64 mg Q4W (SS) Treatment Period | 0/39 (0%) | 0/39 (0%) | 16/39 (41%) |
| Bimekizumab 160 mg Q4W (SS) Treatment Period | 0/43 (0%) | 0/43 (0%) | 12/43 (27.9%) |
| Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period | 0/40 (0%) | 0/40 (0%) | 12/40 (30%) |
| Bimekizumab 320 mg Q4W (SS) Treatment Period | 0/43 (0%) | 0/43 (0%) | 14/43 (32.6%) |
| Bimekizumab 480 mg Q4W (SS) Treatment Period | 0/43 (0%) | 1/43 (2.3%) | 10/43 (23.3%) |
| Placebo (SS) Post-Treatment Period | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Bimekizumab 64 mg Q4W (SS) Post-Treatment Period | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) |
| Bimekizumab 160 mg Q4W (SS) Post-Treatment Period | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Bimekizumab 320 mg Q4W (SS) Post-Treatment Period | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Bimekizumab 480 mg Q4W (SS) Post-Treatment Period | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Event | Placebo (SS) Treatment Period | Bimekizumab 64 mg Q4W (SS) Treatment Period | Bimekizumab 160 mg Q4W (SS) Treatment Period | Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period | Bimekizumab 320 mg Q4W (SS) Treatment Period | Bimekizumab 480 mg Q4W (SS) Treatment Period | Placebo (SS) Post-Treatment Period | Bimekizumab 64 mg Q4W (SS) Post-Treatment Period | Bimekizumab 160 mg Q4W (SS) Post-Treatment Period | Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period | Bimekizumab 320 mg Q4W (SS) Post-Treatment Period | Bimekizumab 480 mg Q4W (SS) Post-Treatment Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 | 0/42 | 1/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Meningitis viralInfections and infestations | 1/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Large intestine polypGastrointestinal disorders | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 1/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 1/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Event | Placebo (SS) Treatment Period | Bimekizumab 64 mg Q4W (SS) Treatment Period | Bimekizumab 160 mg Q4W (SS) Treatment Period | Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period | Bimekizumab 320 mg Q4W (SS) Treatment Period | Bimekizumab 480 mg Q4W (SS) Treatment Period | Placebo (SS) Post-Treatment Period | Bimekizumab 64 mg Q4W (SS) Post-Treatment Period | Bimekizumab 160 mg Q4W (SS) Post-Treatment Period | Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period | Bimekizumab 320 mg Q4W (SS) Post-Treatment Period | Bimekizumab 480 mg Q4W (SS) Post-Treatment Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 2/42 | 5/39 | 3/43 | 3/40 | 6/43 | 4/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Upper respiratory tract infectionInfections and infestations | 1/42 | 5/39 | 2/43 | 3/40 | 2/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| HypertensionVascular disorders | 3/42 | 1/39 | 1/43 | 1/40 | 0/43 | 1/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Oral candidiasisInfections and infestations | 0/42 | 0/39 | 0/43 | 1/40 | 3/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Gamma-glutamyltransferase increasedInvestigations | 1/42 | 0/39 | 3/43 | 2/40 | 1/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/42 | 2/39 | 0/43 | 1/40 | 1/43 | 3/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| NeutropeniaBlood and lymphatic system disorders | 0/42 | 2/39 | 0/43 | 1/40 | 2/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| LeukopeniaBlood and lymphatic system disorders | 0/42 | 2/39 | 0/43 | 0/40 | 0/43 | 1/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| VomitingGastrointestinal disorders | 0/42 | 2/39 | 0/43 | 0/40 | 0/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
| Respiratory tract infectionInfections and infestations | 1/42 | 2/39 | 1/43 | 1/40 | 1/43 | 0/43 | 0/42 | 0/39 | 0/43 | 0/40 | 0/43 | 0/43 |
Baseline Characteristics refer to the Safety Set, which consisted of all participants who received at least 1 dose of the study medication.
| Age, Categorical(Participants) | Placebo | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W | Total Title |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 1 | 0 | 0 | 0 | 2 | 3 |
| Between 18 and 65 years | 39 | 36 | 40 | 35 | 39 | 36 | 225 |
| >=65 years | 3 | 2 | 3 | 5 | 4 | 5 | 22 |
| Age, Continuous(years) | Placebo | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W | Total Title |
|---|---|---|---|---|---|---|---|
| Mean | 46.7 ± 12.3 | 44.2 ± 13.8 | 43.4 ± 12.4 | 46.5 ± 15.2 | 42.6 ± 13.6 | 42.9 ± 15.2 | 44.3 ± 13.7 |
| Sex: Female, Male(Participants) | Placebo | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W | Total Title |
|---|---|---|---|---|---|---|---|
| Female | 17 | 19 | 11 | 11 | 15 | 14 | 87 |
| Male | 25 | 20 | 32 | 29 | 28 | 29 | 163 |
| Race/Ethnicity, Customized(Participants) | Placebo | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W | Total Title |
|---|---|---|---|---|---|---|---|
| American Indian/Alaskan native | 0 | 1 | 0 | 0 | 0 | 1 | 2 |
| Asian | 3 | 2 | 4 | 6 | 3 | 4 | 22 |
| Black | 0 | 1 | 0 | 1 | 1 | 0 | 3 |
| White | 39 | 35 | 39 | 33 | 39 | 38 | 223 |
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