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Evaluating sonelokimab for treating active psoriatic arthritis

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

Phase 3 Interventional MoonLake Immunotherapeutics AG · NCT06641076

This study is testing if a new medication called sonelokimab can help adults with active psoriatic arthritis who haven't tried other similar treatments feel better and improve their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment960 (estimated)
Ages18 Years and up
SexAll
SponsorMoonLake Immunotherapeutics AG Industry-sponsored
Drugs / interventionssonelokimab
Locations26 sites (Chandler, Arizona and 25 other locations)
Trial IDNCT06641076 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of sonelokimab, administered subcutaneously, in adults with active psoriatic arthritis who have not previously received biologic disease-modifying antirheumatic drugs. It is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing sonelokimab to a placebo in a parallel-group design. Participants will receive either sonelokimab 60 mg every 4 weeks with or without an induction regimen or a placebo. The study aims to demonstrate significant improvements in disease activity and safety profiles.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of moderate to severe active psoriatic arthritis and current active plaque psoriasis.

Not a fit: Patients with chronic inflammatory conditions other than psoriatic arthritis or psoriasis, or those with inflammatory bowel disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with active psoriatic arthritis who have not yet been treated with biologics.

How similar studies have performed: Other studies have shown success with biologic therapies for psoriatic arthritis, making this approach promising but still requiring validation for sonelokimab.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants must be ≥18 years of age .
2. 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.
3. Participants have moderate to severe active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
3. Participants with a diagnosis of inflammatory bowel disease.
4. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
5. Participants who have an established diagnosis of arthritis mutilans.
6. Previous exposure to sonelokimab.
7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

Where this trial is running

Chandler, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Arthritis, Psoriatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.