Skip to content
DataLookout
Start free
Menu

NCT07771439

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

StatusRecruiting
PhasePhase 3
SponsorSanofi
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Sep 7, 2026 to Oct 12, 2026
  2. Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 2 of 17 entries
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Overall response rate
Timeframe: at week 24

Secondary (17)

Time from the date of randomization to the date of start of new systemic treatment for cGVHD, relapse or recurrence of underlying disease, or death, whichever occurs first.
Proportion of participants achieving at least 6-point reduction from baseline in the modified Lee cGVHD Symptom Scale score at Week 24.
Proportion of participants who achieve an overall response (CR or PR) within up to 24 weeks and without the requirement of new systemic therapy as per NIH consensus response criteria (2014).
Proportion of participants who achieve an overall response (CR or PR) based on NIH consensus response criteria (2014) at any time until start of new systemic therapy for cGVHD.
The time from first response of PR or CR until documented progression, new systemic treatment for cGVHD, or death, whichever occurs first.
Show 12 moreShow less
Time from randomization to the first response (either CR or PR) per NIH consensus response criteria (2014) for cGVHD.
Time from the date of randomization to the date of starting a new systemic therapy for cGVHD.
Proportion of participants who achieve CR or PR based on NIH consensus criteria (2014) at any time point in each involved organ and before the start of new systemic therapy for cGVHD.
The time from the date of randomization to the date of death from any cause.
Proportion of participants with >50% reduction from baseline in daily CS dose at Week 24.
Proportion of participants with discontinuation of CS at Week 24.
Proportion of participants with >50% reduction from baseline in daily CNI dose at Week 24.
Proportion of participants with discontinuation of CNI at Week 24.
Incidence of TEAEs, SAEs, and AESIs.
The cumulative incidence of relapse or recurrence of the underlying disease at any time during the study.
Belumosudil plasma concentrations.
Change from baseline in SF-36v2 domain scores and composite Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.

Arms and interventions

BelumosudilExperimental

Participants will receive belumosudil

best available therapy(BAT)Other

Participants will receive BAT based on the Investigator's judgment

Drugs: Belumosudil

Other: Best available therapy (BAT)

Sites

3 sites in 2 countries

Spain 2, Netherlands 1