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

Launched by MOONLAKE IMMUNOTHERAPEUTICS AG · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called sonelokimab for adults with active psoriatic arthritis (PsA) who haven’t had enough relief from their previous treatments using anti-TNFα medications. The goal is to see how effective and safe sonelokimab is compared to a placebo, which is an inactive treatment. Participants in this study must be at least 18 years old, have had a confirmed diagnosis of psoriatic arthritis for at least six months, and currently have moderate to severe symptoms. They should also have had inadequate results from one or two previous TNFα treatments.

If you or someone you know is interested in participating, they can expect to be part of a study that is focused on finding better ways to manage psoriatic arthritis. Participants will receive either sonelokimab or a placebo and will be monitored for their response to the treatment and any side effects. It's important to note that certain people, including those with specific allergies or other health conditions, may not be eligible to join this trial. Overall, this study aims to help improve treatment options for individuals struggling with psoriatic arthritis.

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.
• • 6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the 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.
• • 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 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