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    Clinical Trial Results:
    A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

    Summary
    EudraCT number
    2016-000420-26
    Trial protocol
    CZ   ES   PL   BG  
    Global end of trial date
    30 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jun 2019
    First version publication date
    13 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UC0011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    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
    28 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored
    Background therapy
    Background therapy as permitted in the protocol
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Nov 2016
    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
    South Africa: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Georgia: 7
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Moldova, Republic of: 7
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Romania: 1
    Worldwide total number of subjects
    23
    EEA total number of subjects
    5
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in November 2016 and concluded in May 2018.

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

    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
    Carer, Assessor, Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    PBO
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Placebo given as an iv infusion at Visit 2 (Day 1) and placebo given as a sc injection at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Arm title
    BKZ 560/420 mg
    Arm description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).
    Arm type
    Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    BKZ
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    560 mg of bimekizumab (BKZ) given as a loading dose iv infusion at Visit 2 (Day 1) followed by 420 mg BKZ given by sc injection at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Number of subjects in period 1
    Placebo BKZ 560/420 mg
    Started
    8
    15
    Completed
    6
    8
    Not completed
    2
    7
         Lack of efficacy
    -
    2
         Adverse event, non-fatal
    -
    2
         Consent withdrawn by subject
    1
    -
         Early study termination
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Reporting group title
    BKZ 560/420 mg
    Reporting group description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Reporting group values
    Placebo BKZ 560/420 mg Total
    Number of subjects
    8 15 23
    Age categorical
    Units: Subjects
        <=18 years
    0 1 1
        Between 18 and 65 years
    8 14 22
        >=65 years
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.8 ± 12.7 38.9 ± 13.5 -
    Gender categorical
    Units: Subjects
        Male
    3 8 11
        Female
    5 7 12
    Subject analysis sets

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 560/420 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the FAS.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Safety Set (SS).

    Subject analysis set title
    BKZ 560/420 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the SS.

    Subject analysis set title
    BKZ 560/420 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Pharmacokinetic-Per Protocol Set (PK-PPS).

    Subject analysis sets values
    Placebo (FAS) BKZ 560/420 mg (FAS) Placebo (SS) BKZ 560/420 mg (SS) BKZ 560/420 mg (PK-PPS)
    Number of subjects
    8
    15
    8
    15
    15
    Age categorical
    Units: Subjects
        <=18 years
    0
    1
    0
    1
    1
        Between 18 and 65 years
    8
    14
    8
    14
    14
        >=65 years
    0
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.8 ± 12.7
    38.9 ± 13.5
    36.8 ± 12.7
    38.9 ± 13.5
    38.9 ± 13.5
    Gender categorical
    Units: Subjects
        Male
    3
    8
    3
    8
    8
        Female
    5
    7
    5
    7
    7

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Reporting group title
    BKZ 560/420 mg
    Reporting group description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days).

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Full Analysis Set (FAS).

    Subject analysis set title
    BKZ 560/420 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the FAS.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Safety Set (SS).

    Subject analysis set title
    BKZ 560/420 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the SS.

    Subject analysis set title
    BKZ 560/420 mg (PK-PPS)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Pharmacokinetic-Per Protocol Set (PK-PPS).

    Primary: Percentage of Participants with Clinical Response (Per Mayo Score) at Week 8

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    End point title
    Percentage of Participants with Clinical Response (Per Mayo Score) at Week 8 [1]
    End point description
    Clinical Response achieved at Week 8 is defined as a decrease from Baseline in Total Mayo Score of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for Rectal Bleeding of at least 1 point or absolute subscore for Rectal Bleeding of 0 (no blood seen) or 1 (streaks of blood with stool less than half the time). The rectal bleeding score ranges from 0 (no blood seen) to 3 (blood alone passes).
    End point type
    Primary
    End point timeframe
    At Week 8
    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: Given the lack of Week 8 data, expected at the end of the study (and lack of subjects completing the required dosing regimen), a decision has been made that none of the planned Bayesian analyses would be performed, as they would lack validity, given the data that would be available at the end of the study.
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    8
    15
    Units: percentage of participants
        number (confidence interval 95%)
    66.7 (30.0 to 90.3)
    41.7 (19.3 to 68.0)
    No statistical analyses for this end point

    Primary: Percentage of participants with Adverse Events throughout the study conduct up to Week 20

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    End point title
    Percentage of participants with Adverse Events throughout the study conduct up to Week 20 [2]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    End point type
    Primary
    End point timeframe
    Up to Week 20
    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: Given the lack of Week 8 data, expected at the end of the study (and lack of subjects completing the required dosing regimen), a decision has been made that none of the planned Bayesian analyses would be performed, as they would lack validity, given the data that would be available at the end of the study.
    End point values
    Placebo (SS) BKZ 560/420 mg (SS)
    Number of subjects analysed
    8
    15
    Units: percentage of participants
        number (not applicable)
    25.0
    80.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Clinical Remission at Week 8

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    End point title
    Percentage of Participants in Clinical Remission at Week 8
    End point description
    Clinical Remission achieved at Week 8 is defined as a Total Mayo Score of lower than or equal to (<=) 2 points, with no individual subscore higher than (>) 1 point. The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    6
    12
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 39.0)
    16.7 (4.7 to 44.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Mucosal Healing at Week 8

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    End point title
    Percentage of Participants with Mucosal Healing at Week 8
    End point description
    Mucosal Healing achieved at Week 8 is defined as an Endoscopic subscore of <=1 point. The endoscopic scores ranges from 0 (normal or inactive disease) to 3 (severe disease).
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    6
    12
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 39.0)
    16.7 (4.7 to 44.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8

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    End point title
    Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    End point description
    A score of 0 on the Stool Frequency Subscore indicates normal numbers of stools for the patient per day, while a score of 1 on the Stool Frequency Subscore indicates 1 or 2 stools more than usual.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    8
    15
    Units: percentage of participants
        number (confidence interval 95%)
    83.3 (43.6 to 97.0)
    33.3 (13.8 to 60.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8

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    End point title
    Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    End point description
    A score of 0 on the PGA Subscore indicates normal disease, while a score of 1 on the PGA Subscore indicates mild disease.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    8
    15
    Units: percentage of participants
        number (confidence interval 95%)
    50.0 (18.8 to 81.2)
    33.3 (13.8 to 60.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8

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    End point title
    Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    End point description
    A score of 0 on the Rectal Bleeding Subscore indicates no blood seen, while a score of 1 on the Rectal Bleeding Subscore indicates streaks of blood with stool less than half the time.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    8
    15
    Units: percentage of participants
        number (confidence interval 95%)
    100 (61.0 to 100)
    83.3 (55.2 to 95.3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-reactive protein (CRP) plasma level at Week 8

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    End point title
    Change from Baseline in C-reactive protein (CRP) plasma level at Week 8
    End point description
    Baseline for CRP was considered Day 1, predose, or if Day 1 measurement was missing, the Screening value was considered Baseline. CRP, measurements that are below the limit of quantification (BLQ) were imputed with half of the lower limit of quantification (LLOQ) for the purpose of calculating changes from Baseline. Measurements above the upper limit of quantification (ALQ), were imputed to the upper quantification limit.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    Placebo (FAS) BKZ 560/420 mg (FAS)
    Number of subjects analysed
    6
    12
    Units: mg/L
        arithmetic mean (standard deviation)
    -5.777 ± 7.725
    20.692 ± 33.249
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, prior to dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, prior to dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Note 3: At Day 1, Pre-dose, the BKZ concentrations were not available.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    15
    Units: ng/mL
        geometric mean (confidence interval 95%)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, 1 hour after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, 1 hour after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    14
    Units: ng/mL
        geometric mean (confidence interval 95%)
    199600 (180100 to 221200)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, 5 hours after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 1, 5 hours after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    12
    Units: ng/mL
        geometric mean (confidence interval 95%)
    206300 (185700 to 229200)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, Pre-dose

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, Pre-dose
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    14
    Units: ng/mL
        geometric mean (confidence interval 95%)
    36620 (30090 to 44580)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, 1.5 hours after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, 1.5 hours after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    14
    Units: ng/mL
        geometric mean (confidence interval 95%)
    35940 (28650 to 45090)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, 5 hours after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 22, 5 hours after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    12
    Units: ng/mL
        geometric mean (confidence interval 95%)
    36540 (29140 to 45810)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, Pre-dose

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, Pre-dose
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    14
    Units: ng/mL
        geometric mean (confidence interval 95%)
    34310 (26380 to 44630)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, 1.5 hours after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, 1.5 hours after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    12
    Units: ng/mL
        geometric mean (confidence interval 95%)
    32740 (24140 to 44400)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, 5 hours after dosing

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 43, 5 hours after dosing
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    12
    Units: ng/mL
        geometric mean (confidence interval 95%)
    36410 (27870 to 47580)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 57

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 57
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    12
    Units: ng/mL
        geometric mean (confidence interval 95%)
    48460 (37230 to 63060)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 85

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 85
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Note 3: Due to low number of subjects (N = 1), Geometric Mean could not be calculated and a placeholder value '999' was used instead, for technical reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    1
    Units: ng/mL
        geometric mean (confidence interval 95%)
    999 (999 to 999)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 99

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 99
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    10
    Units: ng/mL
        geometric mean (confidence interval 95%)
    5586 (2481 to 12570)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 141

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 141
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Note 3: Due to low number of subjects (N = 1), Geometric Mean could not be calculated and a placeholder value '999' was used instead, for technical reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    1
    Units: ng/mL
        geometric mean (confidence interval 95%)
    999 (999 to 999)
    No statistical analyses for this end point

    Secondary: Plasma concentration of Bimekizumab (BKZ) over time - at Day 183

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    End point title
    Plasma concentration of Bimekizumab (BKZ) over time - at Day 183
    End point description
    BKZ plasma concentration was expressed as geometric mean concentration and measure in nanograms per milillitre (ng/mL). Note 1: Values Bellow Limit of Quantification (BLQ) are replaced by value of Lower Limit Of Quantification (LLOQ)/2 (=75ng/mL) in calculations of descriptive statistics. Note 2: Descriptive statistics were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Note 3: As more than 1/3 of data was BLQ, or missing, Geometric Mean could not be calculated and a placeholder value '999' was used instead, for technical reasons.
    End point type
    Secondary
    End point timeframe
    Day 1 sampling for PK evaluation was done: predose (1h prior dosing), 1h (post infusion), and 5h (±1h). At Day 22, 43 blood sampling was done prior dosing, at 1.5 and 5 hours after dosing. From Day 57 to Day 183, a single sample was collected.
    End point values
    BKZ 560/420 mg (PK-PPS)
    Number of subjects analysed
    11
    Units: ng/mL
        geometric mean (confidence interval 95%)
    999 (999 to 999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline, at Day 1 and up to Early Withdrawal Visit, post Week 26
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BKZ 560/420 mg (SS)
    Reporting group description
    Subjects were administered 560 mg of bimekizumab (BKZ) iv infusion at Visit 2 (Day 1) and 2 doses of 420 mg sc BKZ injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the SS.

    Reporting group title
    Placebo (SS)
    Reporting group description
    Subjects were administered one dose of intravenous (iv) placebo infusion at Visit 2 (Day 1) and 2 doses of subcutaneous placebo (sc) injections at Visit 3 (Day 22 ± 2 days) and Visit 4 (Day 43 ± 2 days), forming the Safety Set (SS).

    Serious adverse events
    BKZ 560/420 mg (SS) Placebo (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BKZ 560/420 mg (SS) Placebo (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    2 / 8 (25.00%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    Lymphopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    5
    0
    Abdominal pain
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Anorectal discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Ileus paralytic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Oropharyngitis fungal
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2017
    Adjusted the timing for the Screening Visits, revised the washout duration for concomitant medications, and introduced wording for a potential interim analysis and a new stopping rule should the interim analysis be carried out.

    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.
    Early study termination, due to an imbalance of adverse events with no clear evidence of benefits, resulted in a number of subjects that was too small to enable any definitive conclusions.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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