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    Clinical Trial Results:
    A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN ACTIVE PSORIATIC ARTHRITIS

    Summary
    EudraCT number
    2016-001103-23
    Trial protocol
    HU   CZ   DE   GB  
    Global end of trial date
    16 Jul 2018

    Results information
    Results version number
    v1
    This version publication date
    08 Sep 2019
    First version publication date
    08 Sep 2019
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    PA0008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02969525
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the dose-response based on the efficacy of bimekizumab.
    Protection of trial subjects
    During this study all study participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol. No medication increases or decreases were permitted for medications taken for psoriatic arthritis (PsA) until after the Week 16 protocol assessments. However, a decrease in dosing or dosing frequency of any agent was permitted for reasons of intolerance/Adverse Events (AEs)/side effects at any time.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    27 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 26
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Poland: 108
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    United States: 40
    Worldwide total number of subjects
    206
    EEA total number of subjects
    153
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    185
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in October 2016 and concluded in July 2018.

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Double-Blind Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received Placebo during the 12 Weeks Double-Blind Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered Placebo, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 16 mg
    Arm description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 160 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 160 mg LD
    Arm description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 320 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Number of subjects in period 1
    Placebo BKZ 16 mg BKZ 160 mg BKZ 160 mg LD BKZ 320 mg
    Started
    42
    41
    41
    41
    41
    Completed Double-Blind Period
    42
    41
    40
    39
    41
    Completed Wk12 and started Dose-Blind
    40
    41
    40
    37
    41
    Completed
    40
    41
    40
    37
    41
    Not completed
    2
    0
    1
    4
    0
         Study medication discontinued before Wk12
    2
    -
    -
    2
    -
         Adverse event, non-fatal
    -
    -
    1
    1
    -
         LOW EGFR
    -
    -
    -
    1
    -
    Period 2
    Period 2 title
    Dose-Blind Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Carer, Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo - BKZ 160 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    Placebo - BZK 320 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 16 mg - BKZ 160 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BZK 16 mg - BZK 320 mg
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BZK 160 mg LD - BZK 160 mg
    Arm description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BZK 160 mg - BKZ dose 160 mg
    Arm description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Arm title
    BKZ 320 mg - BKZ 320 mg
    Arm description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered different BKZ doses, as 2 subcutaneous injections, in the lateral abdominal wall, or upper outer thigh.

    Number of subjects in period 2
    Placebo - BKZ 160 mg Placebo - BZK 320 mg BKZ 16 mg - BKZ 160 mg BZK 16 mg - BZK 320 mg BZK 160 mg LD - BZK 160 mg BZK 160 mg - BKZ dose 160 mg BKZ 320 mg - BKZ 320 mg
    Started
    20
    20
    22
    19
    37
    40
    41
    Completed
    20
    18
    22
    18
    34
    38
    39
    Not completed
    0
    2
    0
    1
    3
    2
    2
         Non-cooperating patient
    -
    -
    -
    -
    -
    -
    1
         Withdrew before Safety Follow-up visit
    -
    -
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    1
    1
    1
         Consent withdrawn by subject
    -
    2
    -
    1
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received Placebo during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 16 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 160 mg
    Reporting group description
    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.

    Reporting group title
    BKZ 160 mg LD
    Reporting group description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    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.

    Reporting group values
    Placebo BKZ 16 mg BKZ 160 mg BKZ 160 mg LD BKZ 320 mg Total
    Number of subjects
    42 41 41 41 41 206
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0 0
        Between 18 and 65 years
    38 35 40 36 36 185
        >=65 years
    4 6 1 5 5 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.02 ± 12.07 49.98 ± 13.56 48.00 ± 11.65 49.05 ± 12.99 50.39 ± 12.08 -
    Gender categorical
    Units: Subjects
        Male
    24 24 20 14 23 105
        Female
    18 17 21 27 18 101
    Subject analysis sets

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 16 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    BKZ 160 mg LD (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    BKZ 160 mg + BKZ 160 mg LD (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg Q4W during the 12 Weeks Double-Blind Period followed by Bimekizumab (BKZ) 160 mg Q4W during the 36 Weeks Dose-Blind Period, forming the Safety Set (SS).

    Subject analysis set title
    BKZ 320 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    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 Safety Set (SS).

    Subject analysis set title
    Placebo (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 16 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 160 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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 Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 160 mg LD (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 320 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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 Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    Placebo - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    Placebo - BZK 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BKZ 16 mg - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 16 mg - BZK 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 160 mg LD - BZK 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 160 mg - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BKZ 320 mg - BKZ 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis sets values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS) BKZ 160 mg + BKZ 160 mg LD (SS) BKZ 320 mg (SS) Placebo (PK-PPS) BKZ 16 mg (PK-PPS) BKZ 160 mg (PK-PPS) BKZ 160 mg LD (PK-PPS) BKZ 320 mg (PK-PPS) Placebo - BKZ 160 mg (DBS) Placebo - BZK 320 mg (DBS) BKZ 16 mg - BKZ 160 mg (DBS) BZK 16 mg - BZK 320 mg (DBS) BZK 160 mg LD - BZK 160 mg (DBS) BZK 160 mg - BKZ 160 mg (DBS) BKZ 320 mg - BKZ 320 mg (DBS)
    Number of subjects
    42
    41
    41
    41
    41
    126
    80
    42
    41
    41
    41
    41
    20
    20
    22
    19
    37
    40
    41
    Age categorical
    Units: Subjects
        <=18 years
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Between 18 and 65 years
    38
    35
    40
    36
    36
    38
    35
    40
    36
    36
        >=65 years
    4
    6
    1
    5
    5
    4
    6
    1
    5
    5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.02 ± 12.07
    49.98 ± 13.56
    48.00 ± 11.65
    49.05 ± 12.99
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    49.02 ± 12.07
    49.98 ± 13.56
    48.00 ± 11.65
    49.05 ± 12.99
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    50.39 ± 12.08
    Gender categorical
    Units: Subjects
        Male
    24
    24
    20
    14
    23
    24
    24
    20
    14
    23
        Female
    18
    17
    21
    27
    18
    18
    17
    21
    27
    18

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received Placebo during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 16 mg
    Reporting group description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 160 mg
    Reporting group description
    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.

    Reporting group title
    BKZ 160 mg LD
    Reporting group description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period.

    Reporting group title
    BKZ 320 mg
    Reporting group description
    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.
    Reporting group title
    Placebo - BKZ 160 mg
    Reporting group description
    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.

    Reporting group title
    Placebo - BZK 320 mg
    Reporting group description
    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.

    Reporting group title
    BKZ 16 mg - BKZ 160 mg
    Reporting group description
    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.

    Reporting group title
    BZK 16 mg - BZK 320 mg
    Reporting group description
    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.

    Reporting group title
    BZK 160 mg LD - BZK 160 mg
    Reporting group description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BZK 160 mg - BKZ dose 160 mg
    Reporting group description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.

    Reporting group title
    BKZ 320 mg - BKZ 320 mg
    Reporting group description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 16 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    BKZ 160 mg LD (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 320 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    BKZ 160 mg + BKZ 160 mg LD (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg Q4W during the 12 Weeks Double-Blind Period followed by Bimekizumab (BKZ) 160 mg Q4W during the 36 Weeks Dose-Blind Period, forming the Safety Set (SS).

    Subject analysis set title
    BKZ 320 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    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 Safety Set (SS).

    Subject analysis set title
    Placebo (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 16 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 160 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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 Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 160 mg LD (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    BKZ 320 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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 Pharmacokinetic Per-Protocol Set (PK-PPS).

    Subject analysis set title
    Placebo - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    Placebo - BZK 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BKZ 16 mg - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 16 mg - BZK 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    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. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 160 mg LD - BZK 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BZK 160 mg - BKZ 160 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Subject analysis set title
    BKZ 320 mg - BKZ 320 mg (DBS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    After the 12 Weeks Double-Blind Period participants randomized to Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. Participants are a subgroup from the Dose-Blind Set (DBS). The subgroup contained participants who were part of the PK-PPS and DBS.

    Primary: ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12

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    End point title
    ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
    End point description
    The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: •Tender Joint Count (TJC) based on 78 joints •Swollen Joint Count (SJC) based on 76 joints •3 of the 5 remaining core set measures: -Disease activity as assessed by Patient’s Global Assessment of Disease Activity (PGADA) -Disease activity as assessed by Physician’s Global Assessment of Disease Activity (PhGADA) -Pain as assessed by Patient’s Assessment of Arthritis Pain (PtAAP) -Physical function as assessed by Health Assessment Questionnaire – Disability Index (HAQ-DI) -Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    42
    41
    41
    41
    41
    Units: percentage of subjects
        number (not applicable)
    7.1
    26.8
    41.5
    46.3
    24.4
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    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. The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS) v BKZ 160 mg (FAS) v BKZ 160 mg LD (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.031
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Correlation statistic
    Point estimate
    999
    Confidence interval
         level
    0%
         sides
    2-sided
         lower limit
    999
         upper limit
    999
    Notes
    [1] - 999 and 0% CI are used as placeholders. Using this methodology no point estimator was calculated. The respective correlation statistic was 4.6.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    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 Factor Necrosis (TNF) inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    P-value
    = 0.032 [3]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.13
         upper limit
    15.23
    Notes
    [2] - 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.
    [3] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    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 Factor Necrosis (TNF) inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.001 [5]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    8.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.28
         upper limit
    28.74
    Notes
    [4] - 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.
    [5] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    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 Factor Necrosis (TNF) inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg LD (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    P-value
    < 0.001 [7]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    9.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.73
         upper limit
    34.26
    Notes
    [6] - 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.
    [7] - The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    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 Factor Necrosis (TNF) inhibitor exposure.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other [8]
    P-value
    = 0.051 [9]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1
         upper limit
    13.68
    Notes
    [8] - 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.
    [9] - The p-values were displayed as nominal p-values.

    Secondary: ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12

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    End point title
    ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
    End point description
    The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: •TJC based on 78 joints •SJC based on 76 joints •3 of the 5 remaining core set measures: -Disease activity as assessed by PGADA -Disease activity as assessed by PhGADA -Pain as assessed by PtAAP -Physical function as assessed by HAQ-DI -Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    42
    41
    41
    41
    41
    Units: percentage of subjects
        number (not applicable)
    19.0
    53.7
    73.2
    61.0
    51.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.002 [10]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.73
         upper limit
    12.39
    Notes
    [10] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [11]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.91
         upper limit
    30.95
    Notes
    [11] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg LD (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [12]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.31
         upper limit
    16.84
    Notes
    [12] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.004 [13]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.59
         upper limit
    11.35
    Notes
    [13] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.

    Secondary: ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12

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    End point title
    ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
    End point description
    The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: •TJC based on 78 joints •SJC based on 76 joints •3 of the 5 remaining core set measures: -Disease activity as assessed by PGADA -Disease activity as assessed by PhGADA -Pain as assessed by PtAAP -Physical function as assessed by HAQ-DI -Acute phase response as assessed by hs CRP Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    42
    41
    41
    41
    41
    Units: percentage of subjects
        number (not applicable)
    4.8
    12.2
    19.5
    31.7
    14.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 16 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.279 [14]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    11.31
    Notes
    [14] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.065 [15]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.92
         upper limit
    17.88
    Notes
    [15] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 160 mg LD (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.006 [16]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.77
         upper limit
    31.28
    Notes
    [16] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    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.
    Comparison groups
    Placebo (FAS) v BKZ 320 mg (FAS)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.172 [17]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    13.39
    Notes
    [17] - No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.

    Secondary: PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1

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    End point title
    PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    20
    14
    16
    17
    11
    Units: percentage of subjects
        number (not applicable)
    10.0
    35.7
    62.5
    52.9
    45.5
    No statistical analyses for this end point

    Secondary: PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1

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    End point title
    PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
    End point description
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo (FAS) BKZ 16 mg (FAS) BKZ 160 mg (FAS) BKZ 160 mg LD (FAS) BKZ 320 mg (FAS)
    Number of subjects analysed
    20
    14
    16
    17
    11
    Units: percentage of subjects
        number (not applicable)
    10.0
    57.1
    68.8
    70.6
    72.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 1 and up to the end of safety follow-up visit, 20 weeks after the final dose
    Adverse event reporting additional description
    At Week 12, Placebo and BKZ 16 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg with 160 mg loading dose at Baseline remained on BKZ 160 mg treatment. Subjects randomized to BKZ 160 mg and BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BKZ 320 mg (SS)
    Reporting group description
    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 Safety Set (SS).

    Reporting group title
    BKZ 160 mg + BKZ 160 mg LD (SS)
    Reporting group description
    Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) and Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg Q4W during the 12 Weeks Double-Blind Period followed by Bimekizumab (BKZ) 160 mg Q4W during the 36 Weeks Dose-Blind Period, forming the Safety Set (SS).

    Serious adverse events
    BKZ 320 mg (SS) BKZ 160 mg + BKZ 160 mg LD (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 80 (0.00%)
    8 / 126 (6.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BKZ 320 mg (SS) BKZ 160 mg + BKZ 160 mg LD (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 80 (31.25%)
    39 / 126 (30.95%)
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 80 (2.50%)
    8 / 126 (6.35%)
         occurrences all number
    3
    8
    Bronchitis
         subjects affected / exposed
    3 / 80 (3.75%)
    7 / 126 (5.56%)
         occurrences all number
    3
    8
    Nasopharyngitis
         subjects affected / exposed
    11 / 80 (13.75%)
    12 / 126 (9.52%)
         occurrences all number
    11
    15
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 80 (10.00%)
    12 / 126 (9.52%)
         occurrences all number
    10
    12
    Pharyngitis
         subjects affected / exposed
    7 / 80 (8.75%)
    4 / 126 (3.17%)
         occurrences all number
    7
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2018
    Protocol Amendment 2 was a substantial amendment dated 09 Mar 2018. The purpose of this protocol amendment was the following: •To update the study contact details for the sponsor study physician and clinical trial biostatistician. •To revise the withdrawal criteria Section to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during the study. •To amend the time window between doses during the Double-blind Period of the study. •To add new details for the IMP packaging. •To revise and clarify the SAE criteria for pregnancy for consistency. •To amend the table for identification/exclusion of alternative etiology to include aspartate aminotransferase (AST) and alanine aminotransferase (ALT). A total of 308 study participants were screened and 206 study participants were randomized at the time of this amendment.

    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
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