A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Evidence level: registry entry; no results posted
ROCKaspire, a registered phase 3 placebo-controlled trial of belumosudil added to azithromycin and standard immunosuppression in adults with chronic lung allograft dysfunction, sponsored by Sanofi.
As of . Primary source: ClinicalTrials.gov NCT06082037.
Summary
The ClinicalTrials.gov entry describes a randomised, double-blind, placebo-controlled, multinational phase 3 study followed by open-label extensions. Participants are adults at least one year after bilateral lung transplant who have evidence of progressive CLAD despite azithromycin therapy, and belumosudil or placebo is given on top of azithromycin and standard-of-care immunosuppression. The registry lists the primary outcome as the percent change in FEV1 from baseline to week 26. Enrolment is estimated at 180 participants. The entry was last updated on 23 September 2026. No results are posted.
Details
- registry
- ClinicalTrials.gov
- registryId
- NCT06082037
- registryTitle
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation
- acronym
- ROCKaspire
- sponsor
- Sanofi
- registryStatus
- recruiting
- phase
- Phase 3
- studyType
- interventional
- enrolment
- 180 (estimated)
- startDate
- 2023-10-10 (actual)
- primaryCompletionDate
- 2029-01-29 (estimated)
- intervention
- Belumosudil (drug); Azithromycin (drug); Placebo (drug)
- condition
- Lung Transplant Rejection
- registryLastUpdatePosted
- 2026-09-23
- registryRead
- 2026-10-10
Sources and links
Related
Links from this record
- tests: Belumosudil
- background therapy in both arms: Azithromycin
- ISHLT 2019 CLAD states: Potential, Possible, Probable and Definite
Linked from (derived)
Known gaps in this record
- results: none posted in the registry
- participating centres and investigators: not recorded
- link to a CLADsolve centre record: not made
Information resource only. Not medical advice. Not a substitute for the care of the patient's transplant team.