NCT06641089

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: MoonLake Immunotherapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Detailed description

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Sonelokimab	Sonelokimab
DRUG	Placebo	Placebo
DRUG	Risankizumab	Active comparator

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-01-15
• Completion: 2027-01-15
• First posted: 2024-10-15
• Last updated: 2026-03-30

Locations

128 sites across 11 countries: United States, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hungary, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study