A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

Sponsor
Sanofi
Study ID
NCT07135973
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Belumosudil — DRUG
    Pharmaceutical form:Tablet-Route of administration:Oral

Study Details

This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older. Study details include: * The study duration will be up to 12 months per participant. * The treatment duration will be up to 24 weeks. * The number of visits will be 7.

Key Dates

First listed
Aug 22, 2025
Start date
Aug 10, 2026
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: belumosudil
    200 mg taken orally once daily with food for 24 weeks

Primary Outcome Measure

Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) [ Time Frame: From baseline to 24 weeks ]

Central Contacts

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

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