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

NCT07135973 | Not Yet Recruiting Phase 4

• 1 other identifier: LPS18471
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)

  Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks)

  From baseline to 24 weeks

Secondary Outcomes (12)

• Best overall Response (BoR)

  Baseline to end of study i.e. 12 months

• Duration of Response (DOR)

  Baseline to end of study i.e. 12 months

• Time to Response (TTR)

  Baseline to end of study i.e. 12 months

• Response by organ system (including GSR)

  Baseline to end of study i.e. 12 months

• Time taken for New Treatment (TTNT) or death

  Baseline to end of study i.e. 12 months

Study Arms (1)

belumosudil

EXPERIMENTAL

200 mg taken orally once daily with food for 24 weeks

Drug: Belumosudil

Interventions

Belumosudil DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Also known as: SAR445761, Rezurock

belumosudil

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

belumosudil

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share