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Evaluating sonelokimab for treating psoriatic arthritis in patients who didn't respond to TNF inhibitors

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

Phase 3 Interventional MoonLake Immunotherapeutics AG · NCT06641089

This study is testing if a new medication called sonelokimab can help adults with psoriatic arthritis who didn't get better from previous treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorMoonLake Immunotherapeutics AG Industry-sponsored
Drugs / interventionssonelokimab, risankizumab
Locations135 sites (Avondale, Arizona and 134 other locations)
Trial IDNCT06641089 on ClinicalTrials.gov

What this trial studies

This study aims to confirm the efficacy and safety of sonelokimab in adults with active psoriatic arthritis who have previously shown inadequate response or intolerance to anti-TNFα therapy. It is a Phase 3, randomized, double-blind, placebo-controlled trial comparing two doses of sonelokimab against a placebo and an active reference treatment, risankizumab. Participants will be monitored for improvements in their condition over the course of the trial.

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 a history of inadequate response to TNFα inhibitors.

Not a fit: Patients who have not previously tried TNFα inhibitors or those with mild psoriatic arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with psoriatic arthritis who have not benefited from existing TNFα inhibitors.

How similar studies have performed: Other studies have shown promising results with similar biologic therapies for psoriatic arthritis, indicating potential for success with this approach.

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 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.
6. 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.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
4. Participants with a diagnosis of inflammatory bowel disease.
5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
6. Participants who have an established diagnosis of arthritis mutilans.
7. Previous exposure to sonelokimab.
8. 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

Avondale, Arizona and 134 other locations

+85 more sites — see ClinicalTrials.gov for the full list.

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.