Sonelokimab for Psoriatic Arthritis with Anti-TNFα Inadequate Response

This study is testing a drug called sonelokimab for adults with active psoriatic arthritis (a type of arthritis linked to psoriasis) who haven't responded well to previous anti-TNFα (tumor necrosis factor alpha) treatments. Researchers want to see if sonelokimab is effective and safe compared to a placebo (an inactive substance) and another drug called risankizumab. You might be able to join if you are at least 18 years old, have had psoriatic arthritis for at least six months, and have active disease with a certain number of tender and swollen joints. The main goal is to see how many participants achieve at least a 50% improvement in their symptoms after 16 weeks.

Study design
This is a Phase 3, randomized, double-blind study involving about 600 participants. It compares sonelokimab to a placebo and risankizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 16, but the total follow-up duration is not specified.

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NCT06641089

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
MoonLake Immunotherapeutics AG
~600 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:SonelokimabPlaceboRisankizumab

At a glance

Recruiting sites
125 of 142 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Measured over Week 16 compared to placebo
Arthritis, Psoriatic
142 sites across 29 states
Poland27
Spain13
Bulgaria12
Germany10
Georgia9
Hungary9
Arizona7
Texas7

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  • Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)Week 16 compared to placebo

    Proportion of participants achieving ACR50