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Clinical Trials in the USA / NCT06641076
Active, not recruiting Phase 3

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

NCT06641076 · tracked via the Priya Life Science USA tracker
Sponsor
MoonLake Immunotherapeutics AG
Phase
Phase 3
Started
2024-10-15
Last updated
2026-08-12

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

SonelokimabPlacebo

Sonelokimab: Randomized treatment, parallel-group

Placebo: Randomized treatment, parallel-group

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. 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 consecutive 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.

Primary outcome measure(s)

Trial sites (182)

FacilityCityRegionStatus
Clinical Site Avondale Arizona
Clinical Site Chandler Arizona
Clinical Site Flagstaff Arizona
Clinical Site Mesa Arizona
Clinical Site Phoenix Arizona
Clinical Site Scottsdale Arizona
Clinical Site Tucson Arizona
Clinical Site San Diego California
Clinical Site Upland California
Clinical Site Avon Park Florida
Clinical Site Clearwater Florida
Clinical Site Hialeah Florida
Clinical Site Tampa Florida
Clinical Site Springfield Illinois
Clinical Site Lake Charles Louisiana
Clinical Site Baltimore Maryland
Clinical Site Grand Blanc Michigan
Clinical Site Leland North Carolina
Clinical Site Salisbury North Carolina
Clinical Site Statesville North Carolina
Clinical Site Middleburg Heights Ohio
Clinical Site Portland Oregon
Clinical Site Memphis Tennessee
Clinical Site Allen Texas
Clinical Site Colleyville Texas
Clinical Site Lubbock Texas
Clinical Site Plano Texas
Clinical Site Beckley West Virginia
Clinical Site Pleven Bulgaria
Clinical Site Plovdiv Bulgaria
Clinical Site Plovdiv Bulgaria
Clinical Site Plovdiv Bulgaria
Clinical Site Plovdiv Bulgaria
Clinical Site Rousse Bulgaria
Clinical Site Sofia Bulgaria
Clinical Site Sofia Bulgaria
Clinical Site Sofia Bulgaria
Clinical Site Stara Zagora Bulgaria
Clinical Site Calgary Canada
Clinical Site Trois-Rivières Canada

+ 142 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641076 on ClinicalTrials.gov ↗ ← All trials in the USA