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A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)

NCT07116031 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-05-22

No results posted yet for this study

Summary

This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD.

The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \<12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \<18 years.

Study details include:

The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first.

Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study

Individual participant duration on study will consist of:

Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.

30 days of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.

Conditions

Interventions

DRUG

Belumosudil

Pharmaceutical form:Oral suspension -Route of administration:Oral or nasogastric tube

DRUG

Belumosudil

Pharmaceutical form:Tablet formulation-Route of administration:Oral

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2028-09-25
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116031 on ClinicalTrials.gov