Last updated 11 months ago
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
960 patients around the world
Available in United States, Colombia, Spain
M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
MoonLake Immunotherapeutics AG
1Research sites
960Patients around the world
This study is for people with
Arthritis
Psoriasic arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 moderate to severe 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 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 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.
Sites
BLUECARE SALUD SAS. Complejo Azul CIMA. Bogotá - Colombia
Recruiting
StudyIZAR-1
SponsorMoonLake Immunotherapeutics AG
Study typeInterventional
Conditions
Psoriasic arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06641076
