Clinical Trial Results:
A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects with Moderate to Severe Hidradenitis Suppurativa
Summary
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EudraCT number |
2017-000892-10 |
Trial protocol |
DE BE DK GR |
Global end of trial date |
21 Feb 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Mar 2020
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First version publication date |
07 Mar 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HS0001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03248531 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UCB Biopharma SRL
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Sponsor organisation address |
Allée de la Recherche 60, Brussels, Belgium, 1070
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Public contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Scientific contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Mar 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Feb 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe Hidradenitis Suppurativa (HS).
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Protection of trial subjects |
During the conduct of the study all participants were closely monitored.
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Background therapy |
Subject agreed to daily use (and throughout the entirety of the study) of 1 of the following over-the-counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater. Concomitant use of oral antibiotic therapy for treatment of HS was allowed provided the dosing regimen (dose and frequency) had been stable for at least 4 consecutive weeks (28 days) prior to Baseline. | ||
Evidence for comparator |
Adalimumab is the only approved medicinal product for the treatment of moderate to severe HS with an inadequate response to conventional systemic HS therapy (approved in Sep 2015). | ||
Actual start date of recruitment |
22 Sep 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 46
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Country: Number of subjects enrolled |
Australia: 19
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Country: Number of subjects enrolled |
Belgium: 1
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Country: Number of subjects enrolled |
Denmark: 3
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Country: Number of subjects enrolled |
Germany: 8
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Country: Number of subjects enrolled |
Norway: 2
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Country: Number of subjects enrolled |
Russian Federation: 11
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Worldwide total number of subjects |
90
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
89
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
The study started to enroll patients in September 2017 and concluded in February 2019. | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Assessor, Carer, Investigator, Subject | ||||||||||||||||||||||||||||||||||||
Blinding implementation details |
For reporting of this study, due to limitations of the drop-down list for blinding, the wording Double Blind was utilized instead of Investigator- and Subject-Blind.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
Participants received several placebo applications to keep the blinding and as a control group. | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
PBO
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Placebo will be provided for blinding and as a control group.
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Arm title
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Adalimumab | ||||||||||||||||||||||||||||||||||||
Arm description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications. | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Adalimumab
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Investigational medicinal product code |
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Other name |
Humira®
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Adalimumab in different dosages (dose 1, 2 and 3).
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Arm title
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Bimekizumab | ||||||||||||||||||||||||||||||||||||
Arm description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Bimekizumab
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Investigational medicinal product code |
UCB4940
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Bimekizumab in different dosages (dose 1 and 2).
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Participants received several placebo applications to keep the blinding and as a control group. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Adalimumab
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Reporting group description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bimekizumab
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Reporting group description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Participants received several placebo applications to keep the blinding and as a control group. | ||
Reporting group title |
Adalimumab
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Reporting group description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications. | ||
Reporting group title |
Bimekizumab
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Reporting group description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. | ||
Subject analysis set title |
Placebo (PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants received several placebo applications to keep the blinding and as a control group, forming the Per-Protocol Set (PPS).
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Subject analysis set title |
Adalimumab (PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the PPS.
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Subject analysis set title |
Bimekizumab (PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the PPS.
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Subject analysis set title |
Bimekizumab (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).
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Subject analysis set title |
Placebo (SS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received several placebo applications to keep the blinding and as a control group, forming the Safety Set (SS).
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Subject analysis set title |
Adalimumab (SS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the SS.
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Subject analysis set title |
Bimekizumab (SS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the SS.
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End point title |
Percentage of subjects achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | ||||||||||||||||
End point description |
HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count.
Missing data were handled using non-response imputation (NRI) methods.
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End point type |
Primary
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End point timeframe |
Week 12
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||
Statistical analysis description |
Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
95% credible intervals were presented for the BKZ vs PBO comparison.
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Comparison groups |
Placebo (PPS) v Bimekizumab (PPS)
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||
Parameter type |
Mean posterior difference | ||||||||||||||||
Point estimate |
31.2
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
11 | ||||||||||||||||
upper limit |
50.4 | ||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
10.1
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Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||
Statistical analysis description |
Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
60% credible intervals were presented for the BKZ vs ADA comparison.
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Comparison groups |
Adalimumab (PPS) v Bimekizumab (PPS)
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||
Parameter type |
Mean posterior difference | ||||||||||||||||
Point estimate |
-2.2
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Confidence interval |
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level |
60% | ||||||||||||||||
sides |
2-sided
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lower limit |
-11.2 | ||||||||||||||||
upper limit |
6.6 | ||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
10.6
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Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||
Statistical analysis description |
Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
Pr[Diff > 0%](%) refers to the probability that the BKZ response rate was greater than the PBO response rate.
0% Confidence Interval (CI) [0,999] was used a placeholder.
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Comparison groups |
Placebo (PPS) v Bimekizumab (PPS)
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||
Parameter type |
Pr [Diff>0%] (%) | ||||||||||||||||
Point estimate |
99.8
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Confidence interval |
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level |
0% | ||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||
upper limit |
999 | ||||||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||||||
Statistical analysis description |
Results were based on a Bayesian logistic regression model where the number of responders was assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
Pr[Diff > 0%](%) refers to the probability that the BKZ response rate was greater than the ADA response rate.
0% Confidence Interval (CI) [0,999] was used a placeholder.
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Comparison groups |
Adalimumab (PPS) v Bimekizumab (PPS)
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||
Parameter type |
Pr[Diff > 0%](%) | ||||||||||||||||
Point estimate |
42.1
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Confidence interval |
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level |
0% | ||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||
upper limit |
999 |
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End point title |
Bimekizumab plasma concentration at Day 1 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL).
Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
Note: 999 is being used as a placeholder for values not reportable as per BLQ rules.
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End point type |
Secondary
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End point timeframe |
Day 1
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No statistical analyses for this end point |
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End point title |
Bimekizumab plasma concentration at Week 2 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in ng/mL.
Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
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End point type |
Secondary
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End point timeframe |
Week 2
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No statistical analyses for this end point |
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End point title |
Bimekizumab plasma concentration at Week 4 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in ng/mL.
Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
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End point type |
Secondary
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End point timeframe |
Week 4
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No statistical analyses for this end point |
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End point title |
Bimekizumab plasma concentration at Week 8 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in ng/mL.
Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
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End point type |
Secondary
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End point timeframe |
Week 8
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No statistical analyses for this end point |
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End point title |
Bimekizumab plasma concentration at Week 12 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in ng/mL.
Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
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End point type |
Secondary
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End point timeframe |
Week 12
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No statistical analyses for this end point |
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End point title |
Bimekizumab plasma concentration at Week 30 | ||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in ng/mL.
Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective visit.
Note: 999 is being used as a placeholder for values not reportable as per BLQ rules.
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End point type |
Secondary
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End point timeframe |
Week 30
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No statistical analyses for this end point |
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End point title |
Percentage of participants with at least one adverse event during the study | ||||||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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End point type |
Secondary
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End point timeframe |
From Screening to Safety Follow-Up (Week 30)
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No statistical analyses for this end point |
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End point title |
Percentage of participants with at least one adverse event categorized by maximum severity during the study | ||||||||||||||||||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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End point type |
Secondary
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End point timeframe |
From Screening to Safety Follow-Up (Week 30)
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No statistical analyses for this end point |
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End point title |
Percentage of participants with at least one serious adverse event during the study | ||||||||||||||||
End point description |
A serious adverse event (SAE) was any untoward medical occurrence that at any dose:
- Resulted in death
- Was life-threatening
- Required in patient hospitalization or prolongation of existing hospitalisation
- Was a congenital anomaly or birth defect
- Was an infection that required treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
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End point type |
Secondary
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End point timeframe |
From Screening to Safety Follow-Up (Week 30)
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No statistical analyses for this end point |
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End point title |
Percentage of participants with at least one serious adverse event categorized by severity during the study | ||||||||||||||||||||||||||||
End point description |
A serious adverse event (SAE) was any untoward medical occurrence that at any dose:
- Resulted in death
- Was life-threatening
- Required in patient hospitalization or prolongation of existing hospitalisation
- Was a congenital anomaly or birth defect
- Was an infection that required treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
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End point type |
Secondary
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End point timeframe |
From Screening to Safety Follow-Up (Week 30)
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No statistical analyses for this end point |
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End point title |
Percentage of participants that withdrew due to adverse events during the study | ||||||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in vital signs (blood pressure) | ||||||||||||||||||||||||
End point description |
Blood pressure was measured in millimeters of mercury (mmHg).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in vital signs (pulse rate) | ||||||||||||||||
End point description |
Pulse rate was measured in beats per minute (beats/min).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in body weight | ||||||||||||||||
End point description |
Body weight was measured in kilograms (kg).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in ECG parameters (ECG Mean Heart Rate) | ||||||||||||||||
End point description |
Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in ECG parameters (PR Interval, QRS duration, QT interval, QTcF Interval) | ||||||||||||||||||||||||||||||||
End point description |
PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia’s correction (QTcF) Interval were measured in milliseconds (msec).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes) | ||||||||||||||||
End point description |
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (hematocrit) | ||||||||||||||||
End point description |
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration) | ||||||||||||||||||||||||
End point description |
Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular hemoglobin (HGB)) | ||||||||||||||||
End point description |
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (erythrocytes mean corpuscular volume) | ||||||||||||||||
End point description |
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (platelets) | ||||||||||||||||
End point description |
Platelets was measured in number of platelets per liter (10^9/L).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (leukocytes, basophils, eosinophils, lymphocytes, monocytes, neutrophils) | ||||||||||||||||||||||||||||||||||||||||
End point description |
Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in hematology parameters (basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes) | ||||||||||||||||||||||||||||||||||||
End point description |
Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in biochemistry parameters (bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol, glucose) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in biochemistry parameters (creatinine, bilirubin, direct bilirubin, urate) | ||||||||||||||||||||||||||||||||
End point description |
Creatinine, bilirubin, direct bilirubin, urate were measured in micromols per liter (μmol/L).
Note 1: 999 was used as a placeholder for the values that were not calculated.
Note 2: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in biochemistry parameters (C reactive protein high sensitivity) | ||||||||||||||||
End point description |
C reactive protein high sensitivity was measure in milligrams per liters (mg/L).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in biochemistry parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase) | ||||||||||||||||||||||||||||||||||||
End point description |
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine urobilinogen) | ||||||||||||||||
End point description |
Urine urobilinogen was measured in Ehrlich units per deciliter (EU/dL).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine pH) | ||||||||||||||||
End point description |
Urine pH was measured on a pH scale.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin) | ||||||||||||||||
End point description |
Urine albumin was measured in milligrams per liter (mg/L).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine albumin/creatinine) | ||||||||||||||||
End point description |
Urine albumin/creatinine was measured in milligrams per millimol (mg/mmol).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Change from Baseline until Safety Follow-up Visit in urinalysis parameters (urine creatinine) | ||||||||||||||||
End point description |
Urine creatinine was measured in millimoles per liter (mmol/L).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bilirubin) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine glucose) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine hemoglobin) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine ketones) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine leukocyte esterase) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine nitrite) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine protein) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine bacteria) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine erythrocytes) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine mucus) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in urinalysis parameters (urine squamous epithelial cells) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 30.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from Baseline until Safety Follow-up Visit in physical examination | ||||||||||||||||||||||||||||||||
End point description |
Percentages were based on the number of participants with non-missing physical exam results at Baseline and at Week 30 and on the number of participants with a normal/at least one abnormal physical examination assessment.
Note: The number of participants analyzed in Week 30 (Safety Follow-Up) for each parameter is presented in parentheses following this model (n= n1, n2, n3) where:
n1 = number of participants analyzed in the Placebo (SS) group;
n2 = number of participants analyzed in the Adalimumab (SS) group;
n3 = number of participants analyzed in the Bimekizumab (SS) group.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
From Screening to Safety Follow-Up (Week 30)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Day 1 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 2 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 2
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 4 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 4
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 8 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 8
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 12 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 12
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of participants with positive Bimekizumab anti-drug antibody (ADA) concentration at Week 30 | ||||||||
End point description |
The overall status of a study participant was ‘Positive’ if at any post-Baseline visit the result was positive.
Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 30
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Adverse events were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo (SS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received several placebo applications to keep the blinding and as a control group, forming the Safety Set (SS). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Adalimumab (SS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received one Adalimumab loading dose 1, one Adalimumab dose 2 application and several Adalimumab dose 3 applications, forming the SS. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bimekizumab (SS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications, forming the SS. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
08 Mar 2018 |
Protocol Amendment 1 was dated 08 Mar 2018. The purpose of this substantial amendment was to revise the withdrawal criteria to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during the study. Other key changes included the following:
The statistical analysis section of the protocol was also updated to include text describing the planned analysis of the primary efficacy variable, and text describing the planned interim analyses and sample size re-estimation was revised. The rationale for this was that the observed pattern of study participant recruitment was not as expected at the time of study planning. Consequently, an insufficient number of study participants would have completed the Week 12 visit and would be evaluable for response at the time of the first interim analysis. The risk of performing an analysis with a very small amount of data was that the estimates obtained from the analysis would be unstable and the risk of committing a Type II error would be inflated. To mitigate these risks it was decided to remove the formal futility and sample size re-estimation aspects from the first interim analysis.
Additional changes included updates to study contact information; minor formatting corrections were also made. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |