NCT07223138

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,560 (estimated)
• Sponsor: MoonLake Immunotherapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)

Detailed description

M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Sonelokimab	Open-label

Timeline

• Start date: 2025-11-13
• Primary completion: 2028-02-04
• Completion: 2028-02-04
• First posted: 2025-10-31
• Last updated: 2026-03-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study