This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Time frame: Week 16 compared to placebo
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Proportion of participants achieving ACR20
Time frame: Week 16 compared to placebo
Response rate of participants achieving Minimal Disease Activity (MDA)
Proportion of participants achieving MDA
Time frame: Week 16 compared to placebo
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Change in HAQ-DI from baseline
Time frame: Week 16 compared to placebo
Psoriasis Area and Severity Index (PASI90)
Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
Time frame: Week 16 compared to placebo
Short- form-36 (SF-36) Physical Component Summary (PCS)
Change from Baseline in SF-36 PCS at Week 16
Time frame: Week 16 compared to placebo
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Time frame: Week 16 compared to risankzumab
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Clinical Site
Avondale, Arizona, United States
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