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

NCT ID: NCT07135973

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2028-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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belumosudil

200 mg taken orally once daily with food for 24 weeks

Group Type EXPERIMENTAL

Belumosudil

Intervention Type DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Interventions

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Belumosudil

Pharmaceutical form:Tablet-Route of administration:Oral

Intervention Type DRUG

Other Intervention Names

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SAR445761 Rezurock

Eligibility Criteria

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Exclusion Criteria

Absolute neutrophil count ≤1.5 X 109/L Platelet count ≤ 50 X 109/L Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (\>5 × ULN if due to cGVHD) Total bilirubin ≥ 1.5 X ULN Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3 Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening FEV1 ≤39% or has lung score of 3
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

800-633-1610 ext. option 6

Other Identifiers

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LPS18471

Identifier Type: -

Identifier Source: org_study_id

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