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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2025

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At a glance

  • Drugs Cenerimod (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms OPUS-1
  • Sponsors Idorsia Pharmaceuticals

Most Recent Events

  • 18 Dec 2024 According to Viatris media release, data from Phase 2b CARE study was used to guide the design and dosage choices for the ongoing Phase 3 OPUS program.
  • 14 May 2024 Planned End Date changed from 1 Jun 2026 to 1 May 2027.
  • 14 May 2024 Planned primary completion date changed from 1 Dec 2025 to 31 Oct 2026.

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