A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease

Sponsor
Sanofi
Study ID
NCT07771439
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    Pharmaceutical form:Tablet-Route of administration:oral
  • Best available therapy (BAT) — OTHER
    Participants will receive BAT based on the Investigator's judgment

Study Details

Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization. Participants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria. Study details include: * The study duration will be defined as 3 years from LPI. * Individual participant duration on study will consist of: * Up to 28 days for screening. * Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. * Thirty days of post treatment safety follow-up. * Follow-up for cGVHD status as applicable. * Long-term follow-up until death or end of study, whichever occurs first.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 7, 2026
Status verified
Aug 2026
Primary completion
Sep 14, 2029
Completion
Mar 2, 2032

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belumosudil
    Participants will receive belumosudil
  • Other: best available therapy(BAT)
    Participants will receive BAT based on the Investigator's judgment

Primary Outcome Measure

Overall response rate [ Time Frame: at week 24 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Related Studies