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

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

A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

NCT07135973•Sanofi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
•Participants who had an allogeneic hematopoietic cell transplantation (HCT)
•Previously received at least 2 prior lines of systemic therapy for cGVHD
•Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
•Had persistent cGVHD manifestations and systemic therapy was indicated
•Karnofsky (if aged ≥ 16 years)/Lansky (if aged \<16 years) Performance Score of ≥ 60
•Capable of giving signed informed consent as described in the protocol

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•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
•The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Key Dates

Start Date

April 15, 2026

Primary Completion Date

August 30, 2027

Completion Date

March 17, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Chronic Graft Versus Host Disease

Interventions

Belumosudil

DRUG

Contacts

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

CONTACT

800-633-1610 contact-us@sanofi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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