NCT06641076

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

A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: MoonLake Immunotherapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Sonelokimab	Randomized treatment, parallel-group
DRUG	Placebo	Randomized treatment, parallel-group

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-02-04
• Completion: 2027-02-04
• First posted: 2024-10-15
• Last updated: 2026-03-30

Locations

168 sites across 20 countries: United States, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Spain

Regulatory

• FDA-regulated drug study