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A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

Study acronym: ROCKaspire
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 79 → 82 locations
    • Secondary endpoints: details revised at 1 of 14 entries
    • Eligibility criteria expanded, about 5 words
  2. Study sites: 80 to 79v26
  3. Study sites: 79 to 80v25
  4. Study sites: 80 to 79v24
  5. Primary completion date: Sep 17, 2026 to Jan 29, 2029
    • Study completion date: Jun 2, 2028 to Oct 1, 2030
    • Eligibility criteria expanded, about 20 words
    • Study sites revised (80)
    v23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites revised (80)
    • Collaborators expanded, about 5 words
    v22
  2. Study sites: 79 to 80v21
  3. Study sites: 78 to 79v20
  4. Study sites: 76 to 78v19
  5. Study sites: 73 to 76v18
  6. Study sites: 72 to 73v17
  7. Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 16 to 14
    v16
  8. Study sites: 71 to 72v15
  9. Study sites: 69 to 71v14
  10. Study sites: 65 to 69v13
  11. Study sites: 63 to 65v12
  12. Study sites: 59 to 63v11
  13. Study sites: 54 to 59v10
  14. Study sites: 41 to 54v9
  15. Study sites: 27 to 41v8
  16. Study sites: 24 to 27v7
  17. Study sites: 18 to 24v6
  18. Study sites: 15 to 18v5
  19. Study sites: 13 to 15v4
  20. Study sites: 1 to 13v3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 9, 2023 to Oct 10, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.
Trial Details
NCT Number NCT06082037
Lead Sponsor Sanofi
Collaborators: Meiji Seika Pharma Co., Ltd.
Conditions
(from sponsor)		 Lung Transplant Rejection
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov