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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03896581
Registration number
NCT03896581
Ethics application status
Date submitted
21/03/2019
Date registered
1/04/2019
Date last updated
4/04/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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Scientific title
A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled 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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2017-002804-29
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Secondary ID [2]
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PA0011
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Universal Trial Number (UTN)
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Trial acronym
BE COMPLETE
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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
Other interventions - Placebo
Experimental: Bimekizumab dosage regimen - Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Placebo Comparator: Placebo - Subjects randomized to this arm will receive placebo.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
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) score 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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American College of Rheumatology (ACR) 20 response at Week 16
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Assessment method [6]
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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 [6]
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Week 16
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Secondary outcome [7]
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American College of Rheumatology (ACR) 70 response at Week 16
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Assessment method [7]
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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 [7]
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Week 16
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Secondary outcome [8]
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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 [8]
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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 [8]
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Baseline, Week 4
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Secondary outcome [9]
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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 [9]
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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 [9]
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Baseline, Week 16
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Secondary outcome [10]
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Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
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Assessment method [10]
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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 [10]
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Baseline, Week 16
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Secondary outcome [11]
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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 [11]
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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 [11]
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Baseline, Week 16
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Secondary outcome [12]
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Incidence of treatment-emergent adverse events (TEAEs) during the study
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Assessment method [12]
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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 [12]
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From Baseline until Safety Follow-Up (up to Week 36)
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Secondary outcome [13]
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Incidence of treatment-emergent serious adverse events (SAEs) during the study
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Assessment method [13]
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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 [13]
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From Baseline until Safety Follow-Up (up to Week 36)
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Secondary outcome [14]
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Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
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Assessment method [14]
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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 [14]
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From Baseline until Safety Follow-Up (up to Week 36)
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Eligibility
Key inclusion criteria
- Subject is male or female at least 18 years of age
- Female subjects 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 has a history of inadequate response (lack of efficacy after at least 3 months
of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis
factor alpha (TNF(a)) inhibitors for either PsA or PSO
- 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 except tumor necrosis factor
(TNF) inhibitors for the treatment of PsA or 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
28/03/2019
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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
14/02/2022
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Pa0011 30005 - Camberwell
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Recruitment hospital [2]
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Pa0011 30007 - Victoria Park
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Recruitment hospital [3]
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Pa0011 30006 - Woodville South
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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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- Victoria Park
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Recruitment postcode(s) [3]
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- Woodville South
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Idaho
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Kentucky
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Louisiana
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Rimouski
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Zlin
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Germany
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Catania
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Italy
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Reggio Emilia
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Wroclaw
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Korolev
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Moscow
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Saratov
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Ulyanovsk
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Vladimir
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Yaroslavl
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United Kingdom
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Bradford
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United Kingdom
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Oxford
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United Kingdom
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Stamford
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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
Ethics application status
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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 tumor necrosis
factor alpha-inadequate responders (TNFa-IR) subjects with active Psoriatic Arthritis (PsA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03896581
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Trial related presentations / publications
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Public notes
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03896581
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