A research study to evaluate the efficacy and safety of cenerimod in subjects suffering from SLE

• Research type

  Research Study

• Full title

  A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy

• IRAS ID

  1006716

• Contact name

  Christelle Boniface

• Contact email

  christelle.boniface@idorsia.com

• Sponsor organisation

  Idorsia Pharmaceuticals Ltd

• Eudract number

  2022-002815-47

• Clinicaltrials.gov Identifier

  NCT05672576

• Research summary

  The goal of this clinical trial is to see how well cenerimod is in reducing symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are:
  - How well cenerimod works on top of the treatment already being administered.
  - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.
  Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.
  In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  23/LO/0458

• Date of REC Opinion

  4 Oct 2023

• REC opinion

  Further Information Favourable Opinion