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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

NCT07771439 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2026-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Belumosudil

Pharmaceutical form:Tablet-Route of administration:oral

OTHER

Best available therapy (BAT)

Participants will receive BAT based on the Investigator's judgment

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2029-09-14
Completion
2032-03-02
FDA Drug
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771439 on ClinicalTrials.gov