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New drug safety trial offers hope for cGVHD patients in india

NCT ID NCT07135973

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the safety of a drug called belumosudil in 26 Indian patients aged 12 and older who have chronic graft-versus-host disease (cGVHD), a complication after a stem cell transplant. Participants take the drug for up to 24 weeks, and doctors monitor for side effects and how well the disease responds. The goal is to see if belumosudil is safe enough for broader use in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belumosudil (a tablet taken by mouth)
What this could lead to
If it works, this could confirm that belumosudil is a safe option for managing chronic graft-versus-host disease in Indian patients.
What could go wrong
This is a small, single-arm safety study with only 26 participants, so results may not apply broadly. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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