Informations générales (source: ClinicalTrials.gov)
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 (ROCKaspire)
Interventional
Phase 3
Sanofi (Voir sur ClinicalTrials)
octobre 2023
juin 2028
17 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Olivier BRUGIERE | 05/05/2025 07:12:14 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Investigational Site Number : 2500001 - 92151 - Suresnes - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500002 - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500003 - 44800 - Saint-herblain - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500004 - 75018 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 92350 - Le Plessis-robinson - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500006 - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participant ≥1 year post bilateral lung transplantation at the time of screening
- Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of
post-transplant baseline at screening and at randomization
- Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at
least 3 times a week) prior to randomization
- Participant ≥1 year post bilateral lung transplantation at the time of screening
- Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of
post-transplant baseline at screening and at randomization
- Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at
least 3 times a week) prior to randomization
- FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)
- Lung function decline that can be explained by non-CLAD causes including but not
limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway
stenosis, or tracheobronchomalacia