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.

Inclusion criteria

• Participants must be ≥18 years of age .
• Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
• Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
• Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
• Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Exclusion criteria

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
• Participants with a diagnosis of inflammatory bowel disease.
• Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
• Participants who have an established diagnosis of arthritis mutilans.
• Previous exposure to sonelokimab.
• Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.