Trials / Active Not Recruiting
Active Not RecruitingNCT06143891
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
Detailed description
Up to 2.5 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belumosudil | Pharmaceutical form:Tablet-Route of administration:oral |
| DRUG | Placebo | Pharmaceutical form:Table-Route of administration:oral |
| DRUG | Prednisone | Pharmaceutical form:Tablet-Route of administration:oral |
| DRUG | Prednisolone | Pharmaceutical form:Tablet-Route of administration:oral |
Timeline
- Start date
- 2024-01-23
- Primary completion
- 2028-09-29
- Completion
- 2028-09-29
- First posted
- 2023-11-22
- Last updated
- 2025-10-14
Locations
151 sites across 24 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Israel, Italy, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06143891. Inclusion in this directory is not an endorsement.