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NCT Number: NCT07135973

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belumosudil

Drug

Pharmaceutical form:Tablet-Route of administration:Oral

Other names: SAR445761, Rezurock

Primary outcomes

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

    Time frame: From baseline to 24 weeks

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

Secondary outcomes

  1. Best overall Response (BoR)

    Time frame: Baseline to end of study i.e. 12 months

    Best overall Response (BoR), defined as the proportion of patients who achieved complete response (CR) or partial response (PR) according to the NIH Consensus Criteria.

  2. Duration of Response (DOR)

    Time frame: Baseline to end of study i.e. 12 months

    Duration of Response (DOR) calculated from time of initial PR or CR until documented progression, death, or new systemic therapy.

  3. Time to Response (TTR)

    Time frame: Baseline to end of study i.e. 12 months

  4. Response by organ system (including GSR)

    Time frame: Baseline to end of study i.e. 12 months

  5. Time taken for New Treatment (TTNT) or death

    Time frame: Baseline to end of study i.e. 12 months

  6. Failure-free survival (FFS)

    Time frame: Baseline to end of study i.e. 12 months

  7. Overall survival (OS)

    Time frame: Baseline to end of study i.e. 12 months

  8. Change in Corticosteroid dose.

    Time frame: Baseline to end of study i.e. 12 months

  9. Change in CNI dose

    Time frame: Baseline to end of study i.e. 12 months

  10. Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale

    Time frame: Baseline to end of study i.e. 12 months

    defined as a ≥7-point reduction from baseline in total symptom score on a scale of 0 to 100 which measures the symptoms of chronic GVHD, with higher scores indicating worse symptoms

  11. Pulmonary Function Test (PFT)

    Time frame: Baseline to end of study i.e. 12 months

    Total lung capacity, Residual volume, Forced expiratory volume, Tidal volume

  12. Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)

    Time frame: Baseline to end of study i.e. 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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