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    Clinical Trial Results:
    A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic Arthritis

    Summary
    EudraCT number
    2017-001003-74
    Trial protocol
    HU   CZ   DE  
    Global end of trial date
    29 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PA0009
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03347110
    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 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To Assess the long-term safety and tolerability of bimekizumab administered over a period of up to 2 years.
    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
    Not applicable
    Actual start date of recruitment
    21 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Poland: 94
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    United States: 35
    Worldwide total number of subjects
    183
    EEA total number of subjects
    135
    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)
    165
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set. Participants who completed the study PA0008 (NCT02969525) were eligible to enroll in study PA0009. A total of 184 participants from PA0008 signed the Informed Consent Form and were enrolled in PA0009 study. Among 184 participants, 1 participant did not receive treatment and was not included in analysis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Bimekizumab 160 mg
    Arm description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.
    Arm type
    Experimental

    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 Q4W at prespecified time points.

    Number of subjects in period 1
    Bimekizumab 160 mg
    Started
    183
    Completed
    161
    Not completed
    22
         Other (Participant is incarcerated)
    1
         Lack of efficacy
    2
         Adverse Event, non-fatal
    9
         Consent withdrawn by subject
    9
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bimekizumab 160 mg
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.

    Reporting group values
    Bimekizumab 160 mg Total
    Number of subjects
    183 183
    Age Categorical
    Units: participants
        <=18 years
    0 0
        Between 18 and 65 years
    165 165
        >=65 years
    18 18
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    49.0 ± 12.2 -
    Sex: Female, Male
    Units: participants
        Female
    87 87
        Male
    96 96

    End points

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    End points reporting groups
    Reporting group title
    Bimekizumab 160 mg
    Reporting group description
    Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.

    Subject analysis set title
    Bimekizumab 160 mg (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the Safety Set (SS) which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.

    Subject analysis set title
    Bimekizumab 160 mg (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the Full Analysis Set (FAS) which consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.

    Primary: Percentage of Participants With treatment-emergent adverse events (TEAEs) during the study

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    End point title
    Percentage of Participants With treatment-emergent adverse events (TEAEs) during the study [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant 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. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009. The Safety Set (SS) consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
    End point type
    Primary
    End point timeframe
    From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
    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 endpoint. Results were summarized in tables as descriptive statistics only.
    End point values
    Bimekizumab 160 mg (SS)
    Number of subjects analysed
    183
    Units: percentage of participants
        number (not applicable)
    80.9
    No statistical analyses for this end point

    Primary: Percentage of Participants With treatment-emergent serious adverse events (SAEs) during the study

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    End point title
    Percentage of Participants With treatment-emergent serious adverse events (SAEs) during the study [2]
    End point description
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization. The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
    End point type
    Primary
    End point timeframe
    From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
    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 endpoint. Results were summarized in tables as descriptive statistics only.
    End point values
    Bimekizumab 160 mg (SS)
    Number of subjects analysed
    183
    Units: percentage of participants
        number (not applicable)
    7.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants who withdrew due to treatment-emergent adverse event (TEAE) during the study

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    End point title
    Percentage of Participants who withdrew due to treatment-emergent adverse event (TEAE) during the study
    End point description
    An adverse event (AE) is 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. The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
    End point type
    Secondary
    End point timeframe
    From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
    End point values
    Bimekizumab 160 mg (SS)
    Number of subjects analysed
    183
    Units: percentage of participants
        number (not applicable)
    4.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 calculated relative to Baseline of PA0008
    End point description
    The ACR20 response rate was based on 20% or greater improvement relative to Baseline of PA0008 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). Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis. FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    181
    Units: percentage of participants
        number (not applicable)
    79.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 calculated relative to Baseline of PA0008
    End point description
    The ACR50 response rate was based on 50% or greater improvement relative to Baseline of PA0008 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. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis. FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    181
    Units: percentage of participants
        number (not applicable)
    64.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 calculated relative to Baseline of PA0008
    End point description
    The ACR70 response rate was based on 70% or greater improvement relative to Baseline of PA0008 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. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis. FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    181
    Units: percentage of participants
        number (not applicable)
    47.5
    No statistical analyses for this end point

    Secondary: Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008
    End point description
    The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process). Each item was scored as 0 = not tender or 1 = tender and then were summed for a possible score of 0 to 13, with higher scores indicating worse enthesitis. If 7 or more items were available, MASES was calculated by dividing the summed score with the number of assessments and multiplying the result by 13. If less than 7 items were available, MASES was treated as missing. Subset of study participants in the FAS with Enthesitis at PA0008 Baseline (MASES>0).
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    95
    Units: score on a scale
        arithmetic mean (standard error)
    -2.99 ± 0.33
    No statistical analyses for this end point

    Secondary: Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008
    End point description
    Presence of dactylitis was assessed using the LDI basic which evaluated for a greater than or equal to (>=) 10% difference in the circumference of the digit compared to the opposite digit and was then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). The results from each digit with dactylitis were summed to produce a final score. For the final score, the minimum value for LDI is zero and there is no maximum value. A low score indicates less dactylitis symptoms. A score of zero is considered dactylitis free. Observed values have been reported in this outcome measure. Subset of study participants in the FAS with Dactylitis at PA0008 Baseline (LDI>0).
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    45
    Units: score on a scale
        arithmetic mean (standard deviation)
    -54.31 ± 67.09
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 calculated relative to Baseline of PA0008
    End point description
    PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining % of skin covered with psoriasis (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 PSO area score of the respective section, and weighted by the % of the person’s affected skin for the respective section. Final score between 0=no disease and 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding body surface area (BSA) has not increased compared to the preceding visit. Subset of study participants in FAS with BSA affected by PSO of >=3% at PA0008 Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    120
    Units: percentage of participants
        number (not applicable)
    90.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 calculated relative to Baseline of PA0008

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    End point title
    Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 calculated relative to Baseline of PA0008
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline of PA0008. 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 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. Final score between 0=no disease and 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding BSA has not increased compared to the preceding visit. Subset of study participants in FAS with BSA affected by PSO of >=3% at PA0008 Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline of PA0008, Week 48
    End point values
    Bimekizumab 160 mg (FAS)
    Number of subjects analysed
    120
    Units: percentage of participants
        number (not applicable)
    80.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
    Adverse event reporting additional description
    A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bimekizumab 160 mg (SS)
    Reporting group description
    Participants received BKZ 160 mg as a sc injection Q4W for up to a maximum of 100 weeks. Participants formed the SS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.

    Serious adverse events
    Bimekizumab 160 mg (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 183 (7.65%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal turbinate hypertrophy
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy on contraceptive
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Foot deformity
         subjects affected / exposed
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Chronic sinusitis
         subjects affected / exposed
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Bimekizumab 160 mg (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 183 (44.81%)
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    14 / 183 (7.65%)
         occurrences all number
    15
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    12 / 183 (6.56%)
         occurrences all number
    13
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    13 / 183 (7.10%)
         occurrences all number
    23
    Bronchitis
         subjects affected / exposed
    11 / 183 (6.01%)
         occurrences all number
    15
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 183 (10.93%)
         occurrences all number
    29
    Nasopharyngitis
         subjects affected / exposed
    19 / 183 (10.38%)
         occurrences all number
    24
    Pharyngitis
         subjects affected / exposed
    10 / 183 (5.46%)
         occurrences all number
    11
    Sinusitis
         subjects affected / exposed
    10 / 183 (5.46%)
         occurrences all number
    10

    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
    The purpose of this substantial amendment was the following: • To update the study contact details for the sponsor study physician and clinical trial biostatistician. • Amend the open-label treatment period for clarification, as per request from the regulatory agency. • Amend the study procedures and assessments to be performed at the SFU visit. Efficacy assessments were removed since they were not required at the SFU visit. • Include additional wording to the inclusion criteria (criterion#5) listing acceptable methods of contraception for female study participants. • Amend the exclusion criteria (criterion #2) to include further clarification on when to consult the medical monitor. • 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 revise and clarify the serious adverse event (SAE) criteria for pregnancy for consistency. • Amend the table for identification/exclusion of alternative etiology to include alanine aminotransferase (ALT) and aspartate aminotransferase (AST). • Amend and remove wording from the criteria determined for handling of dropouts or missing data.

    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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