This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
960
Randomized treatment, parallel-group
Randomized treatment, parallel-group
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
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
Response rate of participants achieving Minimal Disease Activity (MDA)
Proportion of participants achieving MDA
Time frame: Week 16
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Change in HAQ-DI from baseline
Time frame: Week 16
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
Short- form-36 (SF-36) Physical Component Summary (PCS)
Change from Baseline in SF-36 PCS at Week 16
Time frame: Week 16
van der Heijde modified Total Sharp Score (vdHmTSS)
Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS)
Time frame: Week 16
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Clinical Site
Avondale, Arizona, United States
Clinical Site
Chandler, Arizona, United States
Clinical Site
Flagstaff, Arizona, United States
Clinical Site
Mesa, Arizona, United States
Clinical Site
Phoenix, Arizona, United States
Clinical Site
Scottsdale, Arizona, United States
Clinical Site
Tucson, Arizona, United States
Clinical Site
San Diego, California, United States
Clinical Site
Upland, California, United States
Clinical Site
Avon Park, Florida, United States
...and 172 more locations