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New hope for kids with transplant complication: belumosudil trial launches

NCT ID NCT07116031

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 3 times

Summary

This study tests the drug belumosudil in children aged 1 to 18 who have moderate-to-severe chronic graft-versus-host disease (cGVHD) after a stem cell transplant, and whose condition has not improved with at least two prior treatments. The trial has two phases: the first finds the right dose for younger children, and the second checks how well the drug works and how safe it is. About 37 children will take part, and the study is currently recruiting.

What this could mean

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

Active substance
belumosudil (also known as Rezurock)
What this could lead to
If successful, this could provide a new treatment option for children with chronic graft-versus-host disease who have not responded to other therapies.
What could go wrong
This is an early-phase trial with only 37 participants, so results may not apply to all children. The drug may cause side effects or fail to improve symptoms.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 37 people

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

Started

Dec 2025

Expected to finish

Feb 2031

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

1 year to 18 years

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: * Participant must be 1 to \<18 years of age, at the time the consent/assent is signed. For Phase 1: participant must be 1 to \<12 years of age, at the time the consent/assent is signed. For Phase 2: participant must be 1 to \<18 years of age, at the time the consent/assent is signed. * Participant has undergone an allogeneic HCT * Has active moderate to severe cGVHD, defined using the NIH Consensus diagnosis and staging criteria for which systemic therapy is required * cGVHD is refractory to or has recurred after at least 2 prior lines of systemic treatment * Has received at least two lines of prior systemic therapy for cGVHD, but no more than 5 lines. * If participant receives corticosteroid therapy for cGVHD, the dose must be stable for at least 2 weeks prior to the first dose of the IMP * Has a Lansky-Play (if aged \<16 years) or Karnofsky (if aged ≥16 years) performance scale of ≥60 * Body weight of 8 kg and above * Contraceptive use by sexually active male and female should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent * Life expectancy of \>6 months * Participants can take the IMP orally or via a nasogastric tube Exclusion Criteria: * Progressive underlying disease or post-transplant lymphoproliferative disease within 4 weeks prior to the first dose of the IMP. * Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years prior to the first dose of the IMP * History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, active, uncontrolled infections, or poorly controlled psychiatric disease) * Has a forced expiratory volume (in the first second; FEV1) ≤39% or has lung score of 3 * Female participants who are pregnant or breastfeeding * Participants who meet any of the following criteria regarding systemic GVHD treatments: * Participants who newly initiated any systemic GVHD treatment within 14 days prior to the first dose of belumosudil. * Participants receiving systemic GVHD treatments ibrutinib, ruxolitinib, mycophenolate (MMF), methotrexate, rituximab, axatilimab, or imatinib who are unable to meet the following requirements: * No dose increases from 14 days prior to belumosudil initiation and continuing for the first 14 days of belumosudil treatment (dose reductions and discontinuations are permitted during this period) * Ability to discontinue these therapies within 14 days after initiating belumosudil (allowing for a maximum overlap period of up to 14 days with belumosudil treatment) * Participants receiving other systemic GVHD treatments (apart from corticosteroids and calcineurin inhibitors) including investigational treatments who have not completed a washout period of at least 28 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil. No washout period is required for extracorporeal photopheresis (ECP) or sirolimus therapy, but these must be discontinued before study treatment initiation. Note: Corticosteroids and calcineurin inhibitors may continue throughout the study. * The use of herbal and recreational drugs within 7 days before the start of study intervention * Participant has had previous exposure to belumosudil * Administration of live or live-attenuated vaccines is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to IMP administration and until study intervention discontinuation * Treatment with any non-GVHD investigational agent, or any investigational device or procedure, within 28 days (or 5 half-lives, whichever is longer) of enrollment, prior to the first dose of the IMP * For Phase 1 only: Administration with strong CYP3A4 inducers is not allowed within 14 days or 5 half-lives (whichever is longer) of the first dose of IMP until the study intervention discontinuation. * For Phase 1 only: PPIs are not allowed within 1 day or 5 half-lives (whichever is longer) of the first dose of IMP and Day 15 of Cycle 1. They can be restarted on Cycle 1 Day 16. * Absolute neutrophil count \<1.0 × 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed within 7 days prior to the ANC test to reach this level during screening * Platelet count \<25 × 109/L. Platelet transfusions are not allowed within 72 hours before hematology screening test. Participants with platelet transfusion refractoriness will be excluded. (Participants who have suboptimal responses to at least 2 transfusions will be considered as platelet transfusion refractory) * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3× upper limit of normal (ULN) (\> 5x ULN if abnormalities are due to cGVHD) * Total bilirubin \>1.5 × ULN (\>3 x ULN if Gilbert's syndrome or if abnormalities are due to cGVHD) * Glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 using the revised Bedside Schwartz calculator * Participants with an active viral disease including hepatitis B virus (HBV) and hepatitis C virus (HCV) * Active uncontrolled Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection * Known history of human immunodeficiency virus (HIV) * Not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures The above information is not intended to contain all considerations relevant to a patient'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 places running it

    33 sites in 13 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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: •••••@•••••

Locations

  • Children's Hospital Los Angeles- Site Number : 8400009

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's National Medical Center - Washington- Site Number : 8400005

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Fred Hutchinson Cancer Research Center- Site Number : 8400002

    RECRUITING

    Seattle, Washington, 98109, United States

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560003

    RECRUITING

    Ghent, 9000, Belgium

  • Investigational Site Number : 1240001

    RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Shanghai, 200040, China

  • Investigational Site Number : 1560002

    RECRUITING

    Suzhou, 215025, China

  • Investigational Site Number : 1560003

    RECRUITING

    Beijing, 100045, China

  • Investigational Site Number : 1560004

    RECRUITING

    Shenzhen, 518026, China

  • Investigational Site Number : 2500001

    RECRUITING

    Paris, 75019, France

  • Investigational Site Number : 2500002

    RECRUITING

    Marseille, 13885, France

  • Investigational Site Number : 2760001

    RECRUITING

    Berlin, 13353, Germany

  • Investigational Site Number : 3760001

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760002

    RECRUITING

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760003

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3760004

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Investigational Site Number : 3760005

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Rome, Roma, 00165, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Turin, Torino, 10126, Italy

  • Investigational Site Number : 3920002

    RECRUITING

    Tokyo, 157-8535, Japan

  • Investigational Site Number : 5280001

    RECRUITING

    Utrecht, 3584 CS, Netherlands

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, 08035, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Madrid, 28009, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Investigational Site Number : 7920001

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    RECRUITING

    London, London, City of, WC1N 3JH, United Kingdom

  • Investigational Site Number : 8260002

    RECRUITING

    Newcastle upon Tyne, England, NE2 4HH, United Kingdom

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001

    RECRUITING

    New York, New York, 10065, United States

  • Texas Children's Hospital- Site Number : 8400008

    RECRUITING

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.