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Trial record 1 of 1 for:    NCT02963506
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A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis (BE AGILE)

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ClinicalTrials.gov Identifier: NCT02963506
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : November 16, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Other: Placebo
Drug: Bimekizumab
Enrollment 303
Recruitment Details The study started to enroll participants in October 2016 and concluded in August 2018.
Pre-assignment Details

The study included a 28-Day Screening Period, followed by a Double-Blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post Week 48.

The Participant Flow refers to the Randomized Set and Dose-Blind Set.

Arm/Group Title 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
Hide Arm/Group Description Participants received placebo during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period. After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. Participants randomized to bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period. Participants randomized to bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.
Period Title: Double-Blind Period
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
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0             0             0             0             0             0
Death             0             0             0             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             1             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             1             1             0             0             0             0             0             0             0             0             0
No compliance             0             1             0             0             0             0             0             0             0             0             0             0             0
Adverse event, non fatal after Wk12             0             1             0             0             0             0             0             0             0             0             0             0             0
Period Title: Dose-Blind Period
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
Reason Not Completed
Adverse Event             0             0             0             0             0             1             3             2             2             2             1             1             6
Lack of Efficacy             0             0             0             0             0             0             0             1             0             1             0             0             0
Lost to Follow-up             0             0             0             0             0             1             0             0             1             0             0             1             0
Withdrawal by Subject             0             0             0             0             0             1             2             2             0             1             0             0             0
Sponsor decision             0             0             0             0             0             1             0             0             0             0             0             0             0
Meeting exclusion criteria 9             0             0             0             0             0             0             0             0             0             0             0             0             1
Arm/Group Title Placebo BKZ 16 mg BKZ 64 mg BKZ 160 mg BKZ 320 mg Total Title
Hide Arm/Group Description Participants received placebo during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. [Not Specified]
Overall Number of Baseline Participants 60 61 61 60 61 303
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 61 participants 60 participants 61 participants 303 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
56
  91.8%
59
  96.7%
56
  93.3%
60
  98.4%
291
  96.0%
>=65 years
0
   0.0%
5
   8.2%
2
   3.3%
4
   6.7%
1
   1.6%
12
   4.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 61 participants 61 participants 60 participants 61 participants 303 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 61 participants 60 participants 61 participants 303 participants
Female
11
  18.3%
8
  13.1%
9
  14.8%
8
  13.3%
11
  18.0%
47
  15.5%
Male
49
  81.7%
53
  86.9%
52
  85.2%
52
  86.7%
50
  82.0%
256
  84.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 61 participants 60 participants 61 participants 303 participants
American Indian/Alaskan Native
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
0
   0.0%
1
   0.3%
White
60
 100.0%
58
  95.1%
60
  98.4%
59
  98.3%
61
 100.0%
298
  98.3%
Other/Mixed
0
   0.0%
3
   4.9%
0
   0.0%
1
   1.7%
0
   0.0%
4
   1.3%
1.Primary Outcome
Title Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Measure Type: Number
Unit of Measure: percentage of participants
13.3 29.5 42.6 46.7 45.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS), BKZ 64 mg (FAS), BKZ 160 mg (FAS), BKZ 320 mg (FAS)
Comments Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Correlation statistic
Estimated Value 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value =0.040
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.04 to 6.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value =0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
1.83 to 10.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
2.27 to 13.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
2.19 to 12.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-0.3  (0.17) -0.8  (0.17) -1.4  (0.17) -1.3  (0.17) -1.4  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.86 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.47 to -0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.35 to -0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.45 to -0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Measure Type: Number
Unit of Measure: percentage of participants
28.3 41.0 62.3 58.3 72.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.163
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
0.80 to 3.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
1.84 to 8.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.66 to 7.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
2.92 to 14.28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Measure Type: Number
Unit of Measure: percentage of participants
6.7 29.5 49.2 53.3 54.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
1.74 to 15.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
4.03 to 35.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
4.81 to 42.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-values were displayed as nominal p-values.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
5.02 to 44.27
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.0  (0.38) -1.6  (0.38) -2.6  (0.38) -2.6  (0.38) -2.9  (0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.094
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.31 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.34 to -0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.35 to -0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.60 to -1.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
Arm/Group Title Placebo (FAS) BKZ 16 mg (FAS) BKZ 64 mg (FAS) BKZ 160 mg (FAS) BKZ 320 mg (FAS)
Hide Arm/Group Description:
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 60 61 61 60 61
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-0.7  (0.39) -1.4  (0.38) -1.8  (0.38) -1.9  (0.38) -2.2  (0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 16 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.075
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.35 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 64 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.79 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 160 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.84 to -0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), BKZ 320 mg (FAS)
Comments LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs placebo
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.22 to -0.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During the Study
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized participants who received at least 1 dose of IMP.
Arm/Group Title 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
Hide Arm/Group Description:
This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
Overall Number of Participants Analyzed 60 61 58 149 150
Measure Type: Number
Unit of Measure: percentage of participants
45.0 44.3 34.5 69.8 82.0
8.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized participants who received at least 1 dose of IMP.
Arm/Group Title 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
Hide Arm/Group Description:
This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
Overall Number of Participants Analyzed 60 61 58 149 150
Measure Type: Number
Unit of Measure: percentage of participants
3.3 0 3.4 3.4 4.0
9.Secondary Outcome
Title Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all randomized participants who received at least 1 dose of IMP.
Arm/Group Title 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
Hide Arm/Group Description:
This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
Overall Number of Participants Analyzed 60 61 58 149 150
Measure Type: Number
Unit of Measure: percentage of participants
1.7 3.3 1.7 4.7 6.7
Time Frame Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
Adverse Event Reporting Description At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
 
Arm/Group Title 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
Hide Arm/Group Description This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/61 (0.00%)      0/58 (0.00%)      1/149 (0.67%)      0/150 (0.00%)    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/60 (3.33%)      0/61 (0.00%)      2/58 (3.45%)      5/149 (3.36%)      6/150 (4.00%)    
Blood and lymphatic system disorders           
Anaemia * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/58 (1.72%)  1 0/149 (0.00%)  0 0/150 (0.00%)  0
Cardiac disorders           
Acute myocardial infarction * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
Cardiac arrest * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
Ear and labyrinth disorders           
Inner ear disorder * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Gastrointestinal disorders           
Pancreatitis acute * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Crohn's disease * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Haemorrhoids * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/58 (1.72%)  1 0/149 (0.00%)  0 0/150 (0.00%)  0
Intestinal haemorrhage * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/58 (1.72%)  1 0/149 (0.00%)  0 0/150 (0.00%)  0
Abdominal pain * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 0/150 (0.00%)  0
Infections and infestations           
Bursitis infective * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Abscess limb * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
Pilonidal cyst * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
Erysipelas * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  2 0/150 (0.00%)  0
Urinary tract infection * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
Postoperative wound infection * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 0/150 (0.00%)  0
Injury, poisoning and procedural complications           
Foot fracture * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/58 (1.72%)  1 0/149 (0.00%)  0 0/150 (0.00%)  0
Laceration * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Musculoskeletal and connective tissue disorders           
Osteoarthritis * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Colon adenoma * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/58 (1.72%)  1 0/149 (0.00%)  0 0/150 (0.00%)  0
Nervous system disorders           
Dizziness * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 0/149 (0.00%)  0 1/150 (0.67%)  1
Respiratory, thoracic and mediastinal disorders           
Pneumonia aspiration * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 1/149 (0.67%)  1 0/150 (0.00%)  0
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/60 (3.33%)      2/61 (3.28%)      4/58 (6.90%)      42/149 (28.19%)      56/150 (37.33%)    
Infections and infestations           
Oral candidiasis * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 8/149 (5.37%)  10 8/150 (5.33%)  11
Oral fungal infection * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 8/149 (5.37%)  8 6/150 (4.00%)  8
Bronchitis * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 2/58 (3.45%)  2 4/149 (2.68%)  4 12/150 (8.00%)  12
Nasopharyngitis * 1  0/60 (0.00%)  0 2/61 (3.28%)  2 1/58 (1.72%)  1 13/149 (8.72%)  19 19/150 (12.67%)  22
Pharyngitis * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/58 (0.00%)  0 11/149 (7.38%)  11 7/150 (4.67%)  7
Upper respiratory tract infection * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 1/58 (1.72%)  1 5/149 (3.36%)  7 11/150 (7.33%)  11
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02963506    
Other Study ID Numbers: AS0008
2016-001102-42 ( EudraCT Number )
First Submitted: November 10, 2016
First Posted: November 15, 2016
Results First Submitted: October 21, 2020
Results First Posted: November 16, 2020
Last Update Posted: December 17, 2020