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A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term 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, Open-label, Single-arm, Extension Study to Evaluate the Long-term 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: 04 Jun 2025

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At a glance

  • Drugs Cenerimod (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Adverse reactions
  • Acronyms OPUS OLE
  • Sponsors Idorsia Pharmaceuticals

Most Recent Events

  • 07 Feb 2025 Planned primary completion date changed from 1 Nov 2027 to 1 May 2028.
  • 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.
  • 26 Aug 2024 Status changed from not yet recruiting to recruiting.

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