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Clinical Trials in the UK / NCT06641089
Recruiting Phase 3

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

NCT06641089 · tracked via the Priya Life Science UK tracker
Sponsor
MoonLake Immunotherapeutics AG
Phase
Phase 3
Started
2024-10-15
Last updated
2026-09-11

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

SonelokimabPlaceboRisankizumab

Sonelokimab: Sonelokimab

Placebo: Placebo

Risankizumab: Active comparator

Study summary

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.

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. 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

Primary outcome measure(s)

Trial sites (143)

FacilityCityRegionStatus
Clinical Site Avondale Arizona Recruiting
Clinical Site Chandler Arizona Completed
Clinical Site Flagstaff Arizona Completed
Clinical Site Mesa Arizona Recruiting
Clinical Site Phoenix Arizona Recruiting
Clinical Site Scottsdale Arizona Recruiting
Clinical Site Tucson Arizona Recruiting
Clinical Site Jonesboro Arkansas Recruiting
Clinical Site La Jolla California Recruiting
Clinical Site Pomona California Recruiting
Clinical Site San Diego California Completed
Clinical Site Santa Monica California Recruiting
Clinical Site Thousand Oaks California Recruiting
Clinical Site Upland California Recruiting
Clinical Site Avon Park Florida Recruiting
Clinical Site Clearwater Florida Recruiting
Clinical Site Hialeah Florida Recruiting
Clinical Site Miami Gardens Florida Recruiting
Clinical Site Tampa Florida Recruiting
Clinical Site Zephyrhills Florida Recruiting
Clinical Site Gainesville Georgia Recruiting
Clinical Site Springfield Illinois Recruiting
Clinical Site Lake Charles Louisiana Recruiting
Clinical Site Baltimore Maryland Recruiting
Clinical Site Grand Blanc Michigan Completed
Clinical Site Brooklyn New York Recruiting
Clinical Site Rochester New York Recruiting
Clinical Site Charlotte North Carolina Recruiting
Clinical Site Leland North Carolina Recruiting
Clinical Site Middleburg Heights Ohio Recruiting
Clinical Site Portland Oregon Recruiting
Clinical Site Duncansville Pennsylvania Recruiting
Clinical Site Jackson Tennessee Recruiting
Clinical Site Memphis Tennessee Recruiting
Clinical Site Murfreesboro Tennessee Completed
Clinical Site Allen Texas Completed
Clinical Site Austin Texas Recruiting
Clinical Site Baytown Texas Recruiting
Clinical Site Colleyville Texas Recruiting
Clinical Site Houston Texas Completed

+ 103 more sites — see the full list on the official registry below.

On this site

📄 Skyrizi (risankizumab) drug profile →

More MoonLake Immunotherapeutics AG trials in the UK

Other trials for the same condition

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 NCT06641089 on ClinicalTrials.gov ↗ ← All trials in the UK