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A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Study acronym: OPUS-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Oct 31, 2026 → Mar 31, 2027
See other at-risk trials from Viatris Innovation GmbH

Record History

  1. Primary completion pushed from Oct 31, 2026 to Mar 31, 2027 Completion pushed from May 1, 2027 to Sep 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 Sep 30, 2027
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 27 of 198 sites
    • Publications: details revised at 1 of 1 entry
  2. 3 versions Re-verified since May 5, 2026, no change to tracked fieldsv42-v44
  3. Trial status changed: Recruiting → Active, Not Recruiting Enrollment increased: 420 → 470 participants · Trial sites reduced: 216 → 198 locationsv41 Show 2 more changesShow less
    • Enrollment increased: 420 → 470 participants
    • Trial sites reduced: 216 → 198 locations
  4. Study sites: 214 to 216v40
  5. Study sites: 204 to 214v39
Show 37 earlier versionsHide 37 earlier versions
  1. Study sites: 195 to 204v38
  2. Study sites: 171 to 195v37
  3. Study sites: 150 to 171v36
  4. Lead sponsor: Idorsia Pharmaceuticals Ltd. to Viatris Innovation GmbH Site details revised at 5 of 150 sitesv35 Show 1 more changeShow less
    • Site details revised at 5 of 150 sites
  5. Eligibility criteria expanded, about 35 wordsv34 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 148 to 150v33
  7. Site details revised at 7 of 148 sitesv32
  8. Site details revised at 10 of 148 sitesv31
  9. Study sites: 142 to 148v30
  10. Study sites: 141 to 142v29
  11. Study sites: 128 to 141v28
  12. Study sites: 127 to 128v27
  13. Study sites: 125 to 127v26
  14. Study sites: 121 to 125v25
  15. Study sites: 118 to 121v24
  16. Site details revised at 16 of 118 sitesv23
  17. Site details revised at 3 of 118 sitesv22
  18. Study sites: 87 to 118v21
  19. Study sites: 78 to 87v20
  20. Primary completion date: Dec 2025 to Oct 31, 2026 Primary endpoint revised · Study sites: 73 to 78 · Completion date: Jun 2026 to May 1, 2027 · 2 morev19 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 73 to 78
    • Completion date: Jun 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: 57 to 73v18
  22. Study sites: 49 to 57v17
  23. Study sites: 42 to 49v16
  24. Study sites: 34 to 42v15
  25. Re-verified, no change to tracked fieldsv14
  26. Study sites: 32 to 34v13
  27. Study sites: 29 to 32v12
  28. Study sites: 20 to 29v11
  29. Study sites: 18 to 20v10
  30. Study sites: 17 to 18v9
  31. Study sites: 13 to 17v8
  32. Study sites: 8 to 13v7
  33. Study sites: 5 to 8v6
  34. Primary completion date: Aug 2025 to Dec 2025 Completion date: Feb 2026 to Jun 2026v5 Show 1 more changeShow less
    • Completion date: Feb 2026 to Jun 2026
  35. Study sites: 3 to 5v4
  36. Study sites: 2 to 3v3
  37. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Dec 2022 to Dec 13, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 2022 to Dec 13, 2022
  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 Erythematosus 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 NCT05648500
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 470 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov