The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
553
Study participants will receive bimekizumab at pre-specified time points.
Study participants will receive risankizumab at pre-specified time points.
Study participants will receive placebo at pre-specified time points.
American College of Rheumatology 50 (ACR50) at Week 16
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline. * TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms) * Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain). * Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. * High sensitivity C-reactive protein (hs-CRP) in mg/L
Time frame: Week 16
Minimal Disease Activity (MDA) at Week 16
A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: * Tender joint count ≤1 * Swollen joint count ≤1 * PASI ≤1 or BSA ≤3 * PtAAP VAS ≤15 * PGA-PsA VAS ≤20 * HAQ-DI ≤0.5 * Tender enthesial points ≤1
Time frame: Week 16
Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline. The PASI100 response is based on at least 100% improvement in the PASI score. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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 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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Pa0016 50662
Gilbert, Arizona, United States
Pa0016 50062
Glendale, Arizona, United States
Pa0016 50058
Phoenix, Arizona, United States
Pa0016 50131
Sun City, Arizona, United States
Pa0016 50654
Covina, California, United States
Pa0016 50663
San Diego, California, United States
Pa0016 50672
Santa Monica, California, United States
Pa0016 50630
Clearwater, Florida, United States
Pa0016 50679
Cutler Bay, Florida, United States
Pa0016 50685
Fort Lauderdale, Florida, United States
...and 117 more locations
Time frame: Week 16
American College of Rheumatology 50 (ACR50) at Week 4
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline. * TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms) * Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain). * Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. * High sensitivity C-reactive protein (hs-CRP) in mg/L
Time frame: Week 4
Incidence of Participants With Treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Time frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
Incidence of Participants With Treatment-emergent serious AEs
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 * Results in permanent or significant disability/incapacity * 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
Time frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
Time frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)