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A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

Study acronym: OPUS-2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 31, 2026 → Dec 31, 2026
See other at-risk trials from Viatris Innovation GmbH

Record History

  1. Primary completion pushed from Oct 31, 2026 to Dec 31, 2026 Completion pushed from May 1, 2027 to Jun 30, 2027 · Eligibility criteria expanded, about 49 words · Secondary endpoints: details revised at 2 of 3 entries · 2 more Show 5 more changesShow less
    • Completion pushed from May 1, 2027 to Jun 30, 2027
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 28 of 147 sites
    • Publications: details revised at 1 of 1 entry
  2. 2 versions Re-verified since Jul 13, 2026, no change to tracked fieldsv40-v41
  3. Study sites: 148 to 147v39
  4. Study sites: 147 to 148v38
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 420 to confirmed 451 · Study sites: 167 to 147v37 Show 2 more changesShow less
    • Enrollment target: estimated 420 to confirmed 451
    • Study sites: 167 to 147
Show 35 earlier versionsHide 35 earlier versions
  1. Site details revised at 1 of 167 sitesv36
  2. Study sites: 146 to 167v35
  3. Study sites: 144 to 146v34
  4. Lead sponsor: Idorsia Pharmaceuticals Ltd. to Viatris Innovation GmbH Site details revised at 5 of 144 sitesv33 Show 1 more changeShow less
    • Site details revised at 5 of 144 sites
  5. Eligibility criteria expanded, about 35 wordsv32 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 5 of 144 sitesv31
  7. Site details revised at 6 of 144 sitesv30
  8. Study sites: 142 to 144v29
  9. Study sites: 139 to 142v28
  10. Study sites: 133 to 139v27
  11. Study sites: 132 to 133v26
  12. Study sites: 129 to 132v25
  13. Site details revised at 2 of 129 sitesv24
  14. Study sites: 123 to 129v23
  15. Study sites: 119 to 123v22
  16. Study sites: 118 to 119v21
  17. Study sites: 110 to 118v20
  18. Study sites: 88 to 110v19
  19. Study sites: 78 to 88v18
  20. Primary completion date: Jan 2026 to Oct 31, 2026 Primary endpoint revised · Study sites: 69 to 78 · Completion date: Jul 2026 to May 1, 2027 · 2 morev17 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 69 to 78
    • Completion date: Jul 2026 to May 1, 2027
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 61 to 69v16
  22. Study sites: 53 to 61v15
  23. Study sites: 40 to 53v14
  24. Study sites: 46 to 40v13
  25. Study sites: 42 to 46v12
  26. Study sites: 30 to 42v11
  27. Study sites: 20 to 30v10
  28. Study sites: 8 to 20v9
  29. Start date: Feb 8, 2023 to Jun 26, 2023v8
  30. Study sites: 4 to 8v7
  31. Study sites: 1 to 4v6
  32. Re-verified, no change to tracked fieldsv5
  33. Start date: Jan 16, 2023 to Feb 8, 2023v4
  34. Primary completion date: Jul 2025 to Jan 2026 Completion date: Aug 2026 to Jul 2026v3 Show 1 more changeShow less
    • Completion date: Aug 2026 to Jul 2026
  35. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 2023 to Jan 16, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Jan 16, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to see how well cenerimod reduces 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.
Trial Details
NCT Number NCT05672576
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 451 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov