Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Recruiting now Phase 3 NCT06641089
Run by MoonLake Immunotherapeutics AG · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
- Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.
🚫 You may not be able to join if…
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- 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 biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
Where this trial is running
- Clinical Site, Avondale, Arizona, United States
- Clinical Site, Chandler, Arizona, United States
- Clinical Site, Flagstaff, Arizona, United States
- Clinical Site, Mesa, Arizona, United States
- Clinical Site, Phoenix, Arizona, United States
- Clinical Site, Scottsdale, Arizona, United States
- Clinical Site, Tucson, Arizona, United States
- Clinical Site, Jonesboro, Arkansas, United States
- Clinical Site, La Jolla, California, United States
- Clinical Site, Pomona, California, United States
- Clinical Site, San Diego, California, United States
- Clinical Site, Santa Monica, California, United States
+ 126 more sites.
Who to contact
Moonlake Clinical Trial Helpdesk · +41 41 510 8022 · ClinicalTrials@moonlaketx.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06641089.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
Beacon is an information tool, not medical advice. Whether a trial is right for you is a decision for you, your doctor, and the study team. Trial details come from the official registry, ClinicalTrials.gov, and may change — always confirm with the study team. Beacon collects no data about you: this page has no cookies, no accounts, and no tracking.