A study to investigate sonelokimab versus placebo and risankizumab in adults with active PsA

• Research type

  Research Study

• Full title

  A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors.

• IRAS ID

  1011163

• Contact name

  Kristian Reich

• Contact email

  regulatory@moonlaketx.com

• Sponsor organisation

  MoonLake Immunotherapeutics AG

• Eudract number

  2024-516219-25

• Clinicaltrials.gov Identifier

  NCT00641089

• Research summary

  The purpose of this study is to evaluate whether the research drug sonelokimab is effective in reducing the signs and symptoms of psoriatic arthritis (PsA) in people with moderate to severe, active disease. Participants in the study must have previously been treated with medications called tumour necrosis factor-α inhibitors (anti-TNFα) but either did not respond well to them or could not tolerate them. Anti-TNFα inhibitors are commonly used to manage psoriatic arthritis.

  In this study, sonelokimab will be compared to both a placebo (a substance that looks like the study drug but has no active ingredients) and risankizumab, a drug already approved for treating psoriatic arthritis. The study will also gather information about the safety and tolerability of sonelokimab.

  Participants will be randomly assigned (by chance, similar to rolling dice) to one of three groups. During the first 16 weeks of the study, they will receive either sonelokimab, risankizumab, or placebo. After Week 16, all participants will receive either sonelokimab or risankizumab until the end of the study at Week 52.

  The study will involve approximately 600 participants at around 118 research sites worldwide.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  25/LO/0057

• Date of REC Opinion

  10 Feb 2025

• REC opinion

  Further Information Favourable Opinion