Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06475742 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Study acronym: OPUS OLE
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 3 months later May 2028 → Sep 2032
See other at-risk trials from Viatris Innovation GmbH

Record History

  1. Primary and study completion pushed from May 2028 to Sep 2032v22
  2. Trial sites expanded: 106 → 122 locations Study description shortened, about 45 wordsv21 Show 1 more changeShow less
    • Study description shortened, about 45 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv20
  4. Trial sites expanded: 92 → 106 locationsv19
  5. Study sites: 85 to 92v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 79 to 85v17
  2. Study sites: 59 to 79v16
  3. Study sites: 52 to 59v15
  4. Lead sponsor: Idorsia Pharmaceuticals Ltd. to Viatris Innovation GmbHv14
  5. 2 versions Re-verified since Jul 24, 2025, no change to tracked fieldsv12-v13
  6. Study sites: 41 to 52v11
  7. Re-verified, no change to tracked fieldsv10
  8. Study sites: 27 to 41v9
  9. Study sites: 19 to 27v8
  10. Study sites: 13 to 19 Primary completion date: Nov 2027 to May 2028v7 Show 1 more changeShow less
    • Primary completion date: Nov 2027 to May 2028
  11. Study sites: 7 to 13v6
  12. Study sites: 3 to 7v5
  13. Study sites: 2 to 3v4
  14. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 2 · Start date changed from estimate of Jul 2024 to Jul 30, 2024v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 2024 to Jul 30, 2024
  15. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus. The main questions it aims to answer are: * Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus. * How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for up to 5 years. Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year. In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for up to 5 years.
Trial Details
NCT Number NCT06475742
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov