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

NCT ID: NCT06641089
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 3
Sponsor: MoonLake Immunotherapeutics AG

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 600 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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

Study locations

111 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Bulgaria, Canada, Czechia, France, Georgia, Germany, Hungary, Poland, Spain, United Kingdom, United States

Ontario, Canada: 1
Essex, United Kingdom: 1
Arizona, United States: 7
Arkansas, United States: 1
California, United States: 6
Florida, United States: 6
Georgia, United States: 1
Illinois, United States: 1
Louisiana, United States: 1
Maryland, United States: 1
Michigan, United States: 1
New York, United States: 2
North Carolina, United States: 2
Ohio, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 1
Tennessee, United States: 3
Texas, United States: 7
Washington, United States: 1
West Virginia, United States: 1

Sample of listed locations

Clinical Site — Pazardzhik, 4400, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Pleven, 5800, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Plovdiv, 4000, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Rousse, 7000, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Sofia, 1462, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Stara Zagora, 6003, Bulgaria — Site recruitment status not specified in the registry data
Clinical Site — Toronto, Ontario, M5S1B2, Canada — Site recruitment status not specified in the registry data
Clinical Site — Calgary, T2N 4L7, Canada — Site recruitment status not specified in the registry data
Clinical Site — Trois-Rivières, G9A 3X2, Canada — Site recruitment status not specified in the registry data
Clinical Site — Waterloo, N2J 1C4, Canada — Site recruitment status not specified in the registry data
Clinical Site — Winnipeg, R3A IM3, Canada — Site recruitment status not specified in the registry data
Clinical Site — Brno, 63800, Czechia — Site recruitment status not specified in the registry data
Clinical Site — Ostrava, 70200, Czechia — Site recruitment status not specified in the registry data
Clinical Site — Studénka, 742 13, Czechia — Site recruitment status not specified in the registry data
Clinical Site — Zlín, 760 01, Czechia — Site recruitment status not specified in the registry data
Clinical Site — Caluire-et-Cuire, 69300, France — Site recruitment status not specified in the registry data
Clinical Site — Montpellier, 34295, France — Site recruitment status not specified in the registry data
Clinical Site — Narbonne, 11100, France — Site recruitment status not specified in the registry data
Clinical Site — Nice, 06001, France — Site recruitment status not specified in the registry data
Clinical Site — Rouen, 76031, France — Site recruitment status not specified in the registry data
Clinical Site — Tours, 37170, France — Site recruitment status not specified in the registry data
Clinical Site — Tbilisi, 0102, Georgia — Site recruitment status not specified in the registry data
Clinical Site — Berlin, 12161, Germany — Site recruitment status not specified in the registry data
Clinical Site — Dresden, 01067, Germany — Site recruitment status not specified in the registry data
Clinical Site — Erlangen, 91054, Germany — Site recruitment status not specified in the registry data

Study details

Start date: October 15, 2024
Primary completion date: January 15, 2027
First posted: October 15, 2024

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06641089
Registry last updated: September 11, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT06641089 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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