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    Clinical Trial Results:
    A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing Spondylitis

    Summary
    EudraCT number
    2017-000957-37
    Trial protocol
    CZ   DE   GR   NL  
    Global end of trial date
    25 May 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Jun 2021
    First version publication date
    10 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AS0013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03215277
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    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
    23 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of bimekizumab compared to certolizumab pegol (CZP) in the treatment of subjects with active Ankylosing Spondylitis (AS)
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol
    Evidence for comparator
    Proof of concept study to compare the efficacy and safety of the already market-authorized tumor necrosis factor-α (TNF-alpha) Inhibitor CZP vs the investigational IL17 A/F inhibitor BKZ in the AS-indication.
    Actual start date of recruitment
    04 Oct 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 11
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Moldova, Republic of: 7
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 31
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    76
    EEA total number of subjects
    59
    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)
    72
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll study participants in October 2017 and concluded in May 2020.

    Pre-assignment
    Screening details
    The Participant Flow refers to the Randomized Set (RS).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor, Carer
    Blinding implementation details
    This is an investigator-blind and subject-blind study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Certolizumab pegol
    Arm description
    Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44.
    Arm type
    Active comparator

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CDP870
    Other name
    CZP, Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CZP 400 mg Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44.

    Arm title
    Bimekizumab
    Arm description
    Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4.

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received BKZ 160 mg Q2W from Week 0 through Week 10 and 320 mg Q4W from Week 12 to Week 44.

    Number of subjects in period 1
    Certolizumab pegol Bimekizumab
    Started
    25
    51
    Completed
    22
    46
    Not completed
    3
    5
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    2
    3
         Participant was unable to attend clinic visit
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Certolizumab pegol
    Reporting group description
    Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4.

    Reporting group values
    Certolizumab pegol Bimekizumab Total
    Number of subjects
    25 51 76
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0
        Between 18 and 65 years
    25 47 72
        >=65 years
    0 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.7 ± 8.2 40.3 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    4 7 11
        Male
    21 44 65

    End points

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    End points reporting groups
    Reporting group title
    Certolizumab pegol
    Reporting group description
    Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44.

    Reporting group title
    Bimekizumab
    Reporting group description
    Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4.

    Subject analysis set title
    Certolizumab pegol (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS).

    Subject analysis set title
    Bimekizumab (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.

    Subject analysis set title
    Certolizumab pegol (PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Per Protocol Set (PPS).

    Subject analysis set title
    Bimekizumab (PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the PPS.

    Primary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

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    End point title
    Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
    End point description
    ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1). Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented. PPS consisted of all study participants in the FAS who had no important protocol deviation affecting the primary efficacy variable. N signifies participants evaluable.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (PPS) Bimekizumab (PPS)
    Number of subjects analysed
    24
    46
    Units: scores on a scale
        arithmetic mean (confidence interval 95%)
    -1.83 (-2.11 to -1.55)
    -2.06 (-2.30 to -1.81)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.
    Comparison groups
    Certolizumab pegol (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Linear
    Parameter type
    Mean Posterior Difference
    Point estimate
    0.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    0.6
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr[Diff>0%](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group. 0% Confidence Interval (CI) [0,999] was used a placeholder.
    Comparison groups
    Certolizumab pegol (PPS) v Bimekizumab (PPS)
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Linear
    Parameter type
    PR[Diff > 0%](%)
    Point estimate
    88.4
    Confidence interval
         level
    0%
         sides
    2-sided
         lower limit
    0
         upper limit
    999

    Primary: Percentage of participants with adverse events (AE) during the study conduct

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    End point title
    Percentage of participants with adverse events (AE) during the study conduct [1]
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
    End point type
    Primary
    End point timeframe
    From Baseline until Safety Follow-Up Visit (up to Week 64)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Certolizumab pegol (SS) Bimekizumab (SS)
    Number of subjects analysed
    25
    51
    Units: percentage of participants
        number (not applicable)
    76.0
    82.4
    No statistical analyses for this end point

    Primary: Percentage of participants with serious adverse events (SAEs) during the study conduct

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    End point title
    Percentage of participants with serious adverse events (SAEs) during the study conduct [2]
    End point description
    An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
    End point type
    Primary
    End point timeframe
    From Baseline until Safety Follow-Up Visit (up to Week 64)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Certolizumab pegol (SS) Bimekizumab (SS)
    Number of subjects analysed
    25
    51
    Units: percentage of participants
        number (not applicable)
    12.0
    9.8
    No statistical analyses for this end point

    Primary: Percentage of participants who withdrew due to an adverse event (AE) during the study conduct

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    End point title
    Percentage of participants who withdrew due to an adverse event (AE) during the study conduct [3]
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
    End point type
    Primary
    End point timeframe
    From Baseline until Safety Follow-Up Visit (up to Week 64)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Certolizumab pegol (SS) Bimekizumab (SS)
    Number of subjects analysed
    25
    51
    Units: percentage of participants
        number (not applicable)
    12.0
    5.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12

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    End point title
    Percentage of participants with Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
    End point description
    ASDAS-ID was defined by ASDAS < 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1). Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. Per-Protocol Set (PPS) consisted of all study participants in the Full Analysis Set (FAS) who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (PPS) Bimekizumab (PPS)
    Number of subjects analysed
    24
    46
    Units: percentage of participants
        number (confidence interval 95%)
    20.8 (9.2 to 40.5)
    23.9 (13.9 to 37.9)
    No statistical analyses for this end point

    Secondary: Percentage of participants with Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12

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    End point title
    Percentage of participants with Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
    End point description
    ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS >=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1). Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. PPS consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Certolizumab pegol (PPS) Bimekizumab (PPS)
    Number of subjects analysed
    24
    46
    Units: percentage of participants
        number (confidence interval 95%)
    45.8 (27.9 to 64.9)
    60.9 (46.5 to 73.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline until Safety Follow-Up Visit (up to Week 64)
    Adverse event reporting additional description
    A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Certolizumab pegol (SS)
    Reporting group description
    Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS).

    Reporting group title
    Bimekizumab (SS)
    Reporting group description
    Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.

    Serious adverse events
    Certolizumab pegol (SS) Bimekizumab (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 51 (9.80%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic arthritis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Certolizumab pegol (SS) Bimekizumab (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 25 (64.00%)
    27 / 51 (52.94%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 51 (5.88%)
         occurrences all number
    1
    5
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 51 (1.96%)
         occurrences all number
    3
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 51 (1.96%)
         occurrences all number
    5
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 51 (3.92%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Periarthritis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Ankylosing spondylitis
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 51 (7.84%)
         occurrences all number
    2
    4
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 25 (0.00%)
    6 / 51 (11.76%)
         occurrences all number
    0
    8
    Oral herpes
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 25 (24.00%)
    10 / 51 (19.61%)
         occurrences all number
    8
    12
    Influenza
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    4
    Pharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    5 / 51 (9.80%)
         occurrences all number
    0
    5
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Tonsillitis
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2018
    The substantial Protocol Amendment 2 included the following key updates: • Withdrawal criteria section to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease or with inflammatory bowel disease flares during the study. • Statistical analysis section of the protocol, text describing the planned analysis of the primary efficacy variable, and text describing the planned interim analyses and sample size re-estimation. The rationale for this was that the observed pattern of study participant recruitment was not as expected at the time of study planning.
    27 Feb 2019
    The substantial Protocol Amendment 3 included the following key updates: • Secondary and other study objectives and variables were updated to evaluate the effect of bimekizumab or certolizumab pegol on changes in bone formation as exploratory. • Objectives related to pharmacokinetic and immunogenicity were updated to other objectives for consistency with the classification of the corresponding variables. • Nonhereditary pharmacogenomic variables and pharmacogenetic variables were updated as exploratory. • A Prefilled syringe (PFS) was available for administration in addition to the vial and corresponding text was added. • An informal unblinded interim analysis when the last randomized study participant had completed the Week 12 Visit was added to facilitate clinical planning.

    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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