A Phase 2 interventional study of Placebo and Bimekizumab in Ankylosing Spondylitis, sponsored by UCB Biopharma S.P.R.L.. Completed at 74 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.
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 efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's enrollment of 303 is above the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing 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.
Subject has moderate to severe active disease as defined by each of the following:
Subjects must have at least 1 of the following:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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 Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Other: Placebo
Subjects will receive for 12 Weeks Bimekizumab Dose 1 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Drug: Bimekizumab
Subjects will receive for 12 Weeks Bimekizumab Dose 2 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Drug: Bimekizumab
Subjects will receive for 48 Weeks Bimekizumab Dose 3.
Drug: Bimekizumab
Subjects will receive for 48 Weeks Bimekizumab Dose 4.
Drug: Bimekizumab
Bimekizumab in different dosages.
Also known as: UCB4940
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Time frame: Week 12
Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L.
Time frame: From Baseline to Week 12
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
The ASAS20 response was defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain \[deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit\]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Time frame: Week 12
Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Time frame: Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
Time frame: From Baseline to Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
Time frame: From Baseline to Week 12
Percentage of Participants With at Least One Adverse Event (AE) During the Study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From Screening until Safety Follow-Up Visit (up to Week 77)
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 hospitalisation or prolongation of existing hospitalisation * 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 jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Screening until Safety Follow-Up Visit (up to Week 77)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms.
Time frame: From Screening until Safety Follow-Up Visit (up to Week 77)
The study started to enroll participants in October 2016 and concluded in August 2018.
| Milestone | Placebo | BKZ 16 mg | BKZ 64 mg | BKZ 160 mg | BKZ 320 mg | Placebo - BKZ 160 mg | Placebo - BKZ 320 mg | BKZ 16 mg - BKZ 160 mg | BKZ 16 mg - BKZ 320 mg | BKZ 64 mg - BKZ 160 mg | BKZ 64 mg - BKZ 320 mg | BKZ 160 mg - BKZ 160 mg | BKZ 320 mg - BKZ 320 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 60 | 61 | 61 | 60 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed double-blind period | 60 | 59 | 59 | 58 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed week 12 - started dose-blind | 60 | 58 | 59 | 58 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 60 | 58 | 59 | 58 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 3 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: No compliance | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event, non fatal after wk12 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | BKZ 16 mg | BKZ 64 mg | BKZ 160 mg | BKZ 320 mg | Placebo - BKZ 160 mg | Placebo - BKZ 320 mg | BKZ 16 mg - BKZ 160 mg | BKZ 16 mg - BKZ 320 mg | BKZ 64 mg - BKZ 160 mg | BKZ 64 mg - BKZ 320 mg | BKZ 160 mg - BKZ 160 mg | BKZ 320 mg - BKZ 320 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 24 | 36 | 31 | 27 | 34 | 25 | 58 | 61 |
| Completed | 0 | 0 | 0 | 0 | 0 | 20 | 31 | 26 | 24 | 30 | 24 | 56 | 54 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 4 | 5 | 5 | 3 | 4 | 1 | 2 | 7 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 2 | 2 | 2 | 1 | 1 | 6 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Sponsor decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Meeting exclusion criteria 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
| percentage of participants | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 | 13.3 | 29.5 | 42.6 | 46.7 | 45.9 |
The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L.
| scores on a scale | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 | -0.3 ± 0.17 | -0.8 ± 0.17 | -1.4 ± 0.17 | -1.3 ± 0.17 | -1.4 ± 0.17 |
The ASAS20 response was defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain \[deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit\]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
| percentage of participants | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12 | 28.3 | 41.0 | 62.3 | 58.3 | 72.1 |
The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
| percentage of participants | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12 | 6.7 | 29.5 | 49.2 | 53.3 | 54.1 |
The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
| scores on a scale | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -1.0 ± 0.38 | -1.6 ± 0.38 | -2.6 ± 0.38 | -2.6 ± 0.38 | -2.9 ± 0.38 |
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
| scores on a scale | Placebo (FAS) | BKZ 16 mg (FAS) | BKZ 64 mg (FAS) | BKZ 160 mg (FAS) | BKZ 320 mg (FAS) |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) | -0.7 ± 0.39 | -1.4 ± 0.38 | -1.8 ± 0.38 | -1.9 ± 0.38 | -2.2 ± 0.38 |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
| percentage of participants | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 64 mg (SS) - up to Wk 12 | BKZ 160 mg (SS) - up to Wk 73 | BKZ 320 mg (SS) - up to Wk 73 |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | 45.0 | 44.3 | 34.5 | 69.8 | 82.0 |
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * 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 jeopardise 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 64 mg (SS) - up to Wk 12 | BKZ 160 mg (SS) - up to Wk 73 | BKZ 320 mg (SS) - up to Wk 73 |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | 3.3 | 0 | 3.4 | 3.4 | 4.0 |
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms.
| percentage of participants | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 64 mg (SS) - up to Wk 12 | BKZ 160 mg (SS) - up to Wk 73 | BKZ 320 mg (SS) - up to Wk 73 |
|---|---|---|---|---|---|
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | 1.7 | 3.3 | 1.7 | 4.7 | 6.7 |
Collected over Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (SS) - up to Wk 12 | 0/60 (0%) | 2/60 (3.3%) | 2/60 (3.3%) |
| BKZ 16 mg (SS) - up to Wk 12 | 0/61 (0%) | 0/61 (0%) | 2/61 (3.3%) |
| BKZ 64 mg (SS) - up to Wk 12 | 0/58 (0%) | 2/58 (3.4%) | 4/58 (6.9%) |
| BKZ 160 mg (SS) - up to Wk 73 | 1/149 (0.7%) | 5/149 (3.4%) | 42/149 (28.2%) |
| BKZ 320 mg (SS) - up to Wk 73 | 0/150 (0%) | 6/150 (4%) | 56/150 (37.3%) |
| Event | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 64 mg (SS) - up to Wk 12 | BKZ 160 mg (SS) - up to Wk 73 | BKZ 320 mg (SS) - up to Wk 73 |
|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/60 | 0/61 | 1/58 | 0/149 | 0/150 |
| HaemorrhoidsGastrointestinal disorders | 0/60 | 0/61 | 1/58 | 0/149 | 0/150 |
| Intestinal haemorrhageGastrointestinal disorders | 0/60 | 0/61 | 1/58 | 0/149 | 0/150 |
| Foot fractureInjury, poisoning and procedural complications | 0/60 | 0/61 | 1/58 | 0/149 | 0/150 |
| Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/60 | 0/61 | 1/58 | 0/149 | 0/150 |
| Abdominal painGastrointestinal disorders | 1/60 | 0/61 | 0/58 | 0/149 | 0/150 |
| Postoperative wound infectionInfections and infestations | 1/60 | 0/61 | 0/58 | 0/149 | 0/150 |
| Acute myocardial infarctionCardiac disorders | 0/60 | 0/61 | 0/58 | 1/149 | 0/150 |
| Cardiac arrestCardiac disorders | 0/60 | 0/61 | 0/58 | 1/149 | 0/150 |
| Abscess limbInfections and infestations | 0/60 | 0/61 | 0/58 | 1/149 | 0/150 |
| Event | Placebo (SS) - up to Wk 12 | BKZ 16 mg (SS) - up to Wk 12 | BKZ 64 mg (SS) - up to Wk 12 | BKZ 160 mg (SS) - up to Wk 73 | BKZ 320 mg (SS) - up to Wk 73 |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/60 | 2/61 | 1/58 | 13/149 | 19/150 |
| BronchitisInfections and infestations | 1/60 | 0/61 | 2/58 | 4/149 | 12/150 |
| PharyngitisInfections and infestations | 0/60 | 0/61 | 0/58 | 11/149 | 7/150 |
| Upper respiratory tract infectionInfections and infestations | 1/60 | 0/61 | 1/58 | 5/149 | 11/150 |
| Oral candidiasisInfections and infestations | 0/60 | 0/61 | 0/58 | 8/149 | 8/150 |
| Oral fungal infectionInfections and infestations | 0/60 | 0/61 | 0/58 | 8/149 | 6/150 |
The Baseline Characteristics refer to the Full Analysis Set (FAS), which consisted 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 64 mg | BKZ 160 mg | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 56 | 59 | 56 | 60 | 291 |
| >=65 years | 0 | 5 | 2 | 4 | 1 | 12 |
| Age, Continuous(years) | Placebo | BKZ 16 mg | BKZ 64 mg | BKZ 160 mg | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Mean | 39.65 ± 10.30 | 43.31 ± 12.59 | 40.41 ± 10.93 | 42.38 ± 13.11 | 45.02 ± 11.39 | 42.16 ± 11.80 |
| Sex: Female, Male(Participants) | Placebo | BKZ 16 mg | BKZ 64 mg | BKZ 160 mg | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| Female | 11 | 8 | 9 | 8 | 11 | 47 |
| Male | 49 | 53 | 52 | 52 | 50 | 256 |
| Race/Ethnicity, Customized(Participants) | Placebo | BKZ 16 mg | BKZ 64 mg | BKZ 160 mg | BKZ 320 mg | Total Title |
|---|---|---|---|---|---|---|
| American Indian/Alaskan Native | 0 | 0 | 1 | 0 | 0 | 1 |
| White | 60 | 58 | 60 | 59 | 61 | 298 |
| Other/Mixed | 0 | 3 | 0 | 1 | 0 | 4 |
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Studies of the drug tested here: Bimekizumab