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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT06641089

Run by

MoonLake Immunotherapeutics AG

People needed

600

Starts

2024-10-15

Expected to finish

2027-01-15

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Clinical Site — Avondale, Arizona, United States (enrolling)
• Clinical Site — Brooklyn, New York, United States (enrolling)
• Clinical Site — Mesa, Arizona, United States (enrolling)
• Clinical Site — Phoenix, Arizona, United States (enrolling)
• Clinical Site — Scottsdale, Arizona, United States (enrolling)
• Clinical Site — Tucson, Arizona, United States (enrolling)
• Clinical Site — Jonesboro, Arkansas, United States (enrolling)
• Clinical Site — La Jolla, California, United States (enrolling)
• Clinical Site — Pomona, California, United States (enrolling)
• Clinical Site — San Diego, California, United States (enrolling)
• Clinical Site — Santa Monica, California, United States (enrolling)
• Clinical Site — Thousand Oaks, California, United States (enrolling)
• Clinical Site — Upland, California, United States (enrolling)
• Clinical Site — Avon Park, Florida, United States (enrolling)
• Clinical Site — Clearwater, Florida, United States (enrolling)
• Clinical Site — Hialeah, Florida, United States (enrolling)
• Clinical Site — Miami Gardens, Florida, United States (enrolling)
• Clinical Site — Tampa, Florida, United States (enrolling)
• Clinical Site — Zephyrhills, Florida, United States (enrolling)
• Clinical Site — Gainesville, Georgia, United States (enrolling)
• Clinical Site — Springfield, Illinois, United States (enrolling)
• Clinical Site — Lake Charles, Louisiana, United States (enrolling)
• Clinical Site — Baltimore, Maryland, United States (enrolling)
• Clinical Site — Grand Blanc, Michigan, United States (enrolling)
• Clinical Site — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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