Recruiting
Phase 2

Belumosudil

Sponsor:

Kadmon, a Sanofi Company

Code:

NCT05567406

Conditions

Chronic Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Belumosudil

Study Details

Brief summary:

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above.

The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

Conditions

Chronic Graft Versus Host Disease

Study ID

NCT05567406

Start date

Jun 16, 2025

Status verified date

Jun, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants are included in the study if any of the following criteria apply:
  • Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
  • Have persistent cGVHD manifestations and systemic therapy is indicated.
  • Karnofsky (if aged ≥ 16 years) / Lansky (if aged < 16 years) Performance Score of ≥ 60.
  • At least 12 years of age; weight ≥ 40 kilograms (kg).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
  • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
  • Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
  • 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, poorly controlled psychiatric disease, or coronary artery disease).
  • Corrected QT interval using Fridericia's formula (QTc\[F\]) > 480 ms.
  • Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Belumosudil

Participants will receive belumosudil orally, once daily (QD) or twice daily (BID) if they are taking strong CYP3A4 inducers or proton pump inhibitors.

Interventions

Belumosudil

Pharmaceutical form: Tablet; Route of administration: Oral

Primary outcome measure

  • Number of participants with treatment emergent adverse events and serious adverse events [ Time Frame: Up to approximately 48 months ]
  • Number of participants with clinically significant laboratory abnormalities [ Time Frame: Up to approximately 12 months ]
  • Change from baseline in systolic and diastolic blood pressure [ Time Frame: Baseline; up to approximately 12 months ]
  • Change from baseline in heart rate [ Time Frame: Baseline; up to approximately 12 months ]
  • Change from baseline in corrected QT interval using Fridericia's formula (QTc[F]) [ Time Frame: Baseline; up to approximately 12 months ]
  • Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]

Central Contacts and Locations

Central contacts

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

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

Locations

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 129

Recruiting

Miami, Florida, United States, 33155

University of Maryland School of Medicine - Baltimore- Site Number : 128

Recruiting

Baltimore, Maryland, United States, 21201

Westchester Medical Center- Site Number : 130

Recruiting

Valhalla, New York, United States, 10595

More Information

Sponsor

Kadmon, a Sanofi Company

Last update posted

Jun 18, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kadmon, a Sanofi Company on 2025-06-18.