Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Key facts

Study ID

NCT06641076

Run by

MoonLake Immunotherapeutics AG

People needed

960

Starts

2024-10-15

Expected to finish

2027-02-04

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.

You may not qualify if…

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• 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 any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

Where it is running

• 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 — San Diego, California, United States
• Clinical Site — Upland, California, United States
• Clinical Site — Avon Park, Florida, United States
• Clinical Site — Clearwater, Florida, United States
• Clinical Site — Hialeah, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Springfield, Illinois, United States
• Clinical Site — Lake Charles, Louisiana, United States
• Clinical Site — Baltimore, Maryland, United States
• Clinical Site — Grand Blanc, Michigan, United States
• Clinical Site — Leland, North Carolina, United States
• Clinical Site — Salisbury, North Carolina, United States
• Clinical Site — Statesville, North Carolina, United States
• Clinical Site — Middleburg Heights, Ohio, United States
• Clinical Site — Portland, Oregon, United States
• Clinical Site — Memphis, Tennessee, United States
• Clinical Site — Allen, Texas, United States
• Clinical Site — Colleyville, Texas, United States
• Clinical Site — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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