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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03895203
Registration number
NCT03895203
Ethics application status
Date submitted
27/03/2019
Date registered
29/03/2019
Titles & IDs
Public title
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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2017-002322-20
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Secondary ID [2]
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PA0010
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Universal Trial Number (UTN)
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Trial acronym
BE OPTIMAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Adalimumab
Other interventions - Placebo
Experimental: Bimekzumab dosage regimen - Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Active comparator: Adalimumab dosage regimen - Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Placebo comparator: Placebo - Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Treatment: Drugs: Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Other interventions: Placebo
Subjects will receive placebo at pre-specified time-points.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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American College of Rheumatology (ACR) 50 response at Week 16
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Assessment method [1]
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The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
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Assessment method [1]
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HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
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Timepoint [1]
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Baseline, Week 16
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Secondary outcome [2]
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Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
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Assessment method [2]
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The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
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Timepoint [2]
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Baseline, Week 4
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Secondary outcome [3]
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Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
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Assessment method [3]
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The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
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Timepoint [3]
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Baseline, Week 16
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Secondary outcome [4]
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Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
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Assessment method [4]
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There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [5]
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Minimal Disease Activity (MDA) at Week 16
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Assessment method [5]
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Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).
A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count \<=1, 2) Swollen joint count \<=1, 3) PASI \<=1 or BSA \<=3; 4) Patient pain Visual Analog Scale (VAS) \<=15, 5) Patient global activity VAS \<=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) \<=0.5 and 7) Tender enthesial points \<=1
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in subjects with elevated hs-CRP and/or at least 1 bone erosion at Baseline at Week 16
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Assessment method [6]
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The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
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Timepoint [6]
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Baseline, Week 16
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Secondary outcome [7]
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Enthesitis-free state in the Leeds Enthesitis Index (LEI) at Week 16 in the subgroup of subjects with enthesitis at Baseline in the pooled population of PA0010 and PA0011
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Assessment method [7]
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Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline.
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Timepoint [7]
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Baseline, Week 16
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Secondary outcome [8]
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Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 16 in the subgroup of subjects with dactylitis at Baseline in the pooled population of PA0010 and PA0011
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Assessment method [8]
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Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a \>=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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American College of Rheumatology (ACR) 20 response at Week 16
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Assessment method [9]
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The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in the overall population at Week 16
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Assessment method [10]
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The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
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Timepoint [10]
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Baseline, Week 16
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Secondary outcome [11]
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American College of Rheumatology (ACR) 70 response at Week 16
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Assessment method [11]
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The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
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Assessment method [12]
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Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
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Timepoint [12]
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Baseline, Week 4
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Secondary outcome [13]
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Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
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Assessment method [13]
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Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
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Timepoint [13]
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Baseline, Week 16
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Secondary outcome [14]
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Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16: PtAAP Visual Analog Scale (VAS)
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Assessment method [14]
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The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
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Timepoint [14]
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Baseline, Week 16
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Secondary outcome [15]
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Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 16 in the subgroup of subjects with enthesitis at Baseline
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Assessment method [15]
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Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline. The SPARCC is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
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Timepoint [15]
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Baseline, Week 16
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Secondary outcome [16]
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Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
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Assessment method [16]
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The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
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Timepoint [16]
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Baseline, Week 16
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Secondary outcome [17]
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Incidence of treatment-emergent adverse events (TEAEs) during the study
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Assessment method [17]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
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Timepoint [17]
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From Baseline until Safety Follow-Up (up to Week 72)
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Secondary outcome [18]
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Incidence of treatment-emergent serious adverse events (SAEs) during the study
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Assessment method [18]
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A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization
* Is a congenital anomaly or birth defect
* Is an infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
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Timepoint [18]
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From Baseline until Safety Follow-Up (up to Week 72)
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Secondary outcome [19]
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Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
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Assessment method [19]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
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Timepoint [19]
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From Baseline until Safety Follow-Up (up to Week 72)
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Eligibility
Key inclusion criteria
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
* Subject is male or female at least 18 years of age
* Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
* Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
* Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
* Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
* Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
* Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
* Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
* Subject has an active infection or a history of recent serious infections
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
* Subject had acute anterior uveitis within 6 weeks of Baseline
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
* Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
* Presence of active suicidal ideation, or moderately severe major depression or severe major depression
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/07/2022
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Sample size
Target
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Accrual to date
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Final
852
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Pa0010 30005 - Camberwell
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Recruitment hospital [2]
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Pa0010 30002 - Clayton
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Recruitment hospital [3]
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Pa0010 30008 - Hobart
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Recruitment hospital [4]
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Pa0010 30003 - Maroochydore
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Recruitment hospital [5]
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Pa0010 30007 - Victoria Park
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Recruitment hospital [6]
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Pa0010 30006 - Woodville
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Recruitment postcode(s) [1]
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- Camberwell
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Hobart
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Recruitment postcode(s) [4]
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- Maroochydore
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Recruitment postcode(s) [5]
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- Victoria Park
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Recruitment postcode(s) [6]
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- Woodville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Missouri
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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West Virginia
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Belgium
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Genk
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Belgium
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Leuven
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Belgium
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Mons
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Canada
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Québec City
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Canada
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Rimouski
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Canada
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Sidney
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Canada
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Trois-Rivières
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Czechia
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Brno
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Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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State/province [28]
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Praha 11
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Czechia
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Praha 2
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Czechia
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Praha 4
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Czechia
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Praha 5
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Czechia
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State/province [32]
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Praha
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Czechia
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State/province [33]
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Uherské Hradište
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Czechia
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Zlín
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France
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Paris
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France
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Tours
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Germany
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Bad Doberan
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Germany
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Berlin
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Germany
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Cottbus
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Leipzig
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Germany
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Magdeburg
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Germany
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Ratingen
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Hungary
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0
Budapest
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0
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Hungary
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State/province [48]
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Hungary
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Eger
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Kistarcsa
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Szentes
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Catania
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Italy
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Italy
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Italy
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Itabashi
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Osaka
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Saitama
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Sasebo
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Suita
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Tokyo
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Poland
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Bialystok
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Gdynia
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Kraków
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Lublin
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Nowa Sól
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Poznan
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Torun
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan'
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Ulyanovsk
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Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
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Coruña
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Córdoba
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Málaga
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Spain
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Sabadell
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Spain
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Vigo
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United Kingdom
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Leeds
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Address
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Ethics approval
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Summary
Brief summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
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Trial website
https://clinicaltrials.gov/study/NCT03895203
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Trial related presentations / publications
Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Merola JF, Tanaka Y, Asahina A, Gossec L, Gottlieb AB, Warren RB, Ink B, Bajracharya R, Shende V, Coarse J, Landewe RB. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023 Nov;82(11):1404-1414. doi: 10.1136/ard-2023-224431. Epub 2023 Sep 11. Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
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Public notes
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Contacts
Principal investigator
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UCB Cares
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Address
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001 844 599 2273
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
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Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.Vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Mero...
[
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Journal
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, W...
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More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT03895203