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

Launched by MOONLAKE IMMUNOTHERAPEUTICS AG · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called sonelokimab to see how well it works and how safe it is for adults with active psoriatic arthritis, a type of arthritis that can cause joint pain and skin problems. Participants in this study will receive sonelokimab through an injection under the skin, and their results will be compared to those who receive a placebo, which is a treatment that looks like the real medication but doesn't contain any active ingredients. The goal is to find out if sonelokimab can help people with psoriatic arthritis who have never taken certain advanced treatments before.

To join the study, participants need to be at least 18 years old and have a confirmed diagnosis of psoriatic arthritis with moderate to severe symptoms. They also need to have ongoing skin issues like plaque psoriasis. However, people with certain other health conditions, those who have had severe reactions to the study medication, or anyone who has previously used biologic treatments for their arthritis or skin condition won't be eligible. If someone qualifies and decides to participate, they can expect regular check-ins and assessments to monitor their progress and any side effects throughout the trial.

Gender

ALL

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 moderate to severe 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 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.