Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Primary Outcome Measures

1. Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
   Proportion of participants achieving ACR50

Secondary Outcome Measures

1. Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
   Proportion of participants achieving ACR20
2. Response rate of participants achieving Minimal Disease Activity (MDA)
   Proportion of participants achieving MDA
3. Health Assessment Questionnaire- Disability Index (HAQ-DI)
   Change in HAQ-DI from baseline
4. 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
5. Short- form-36 (SF-36) Physical Component Summary (PCS)
   Change from Baseline in SF-36 PCS at Week 16
6. van der Heijde modified Total Sharp Score (vdHmTSS)
   Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS)