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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT07116031
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    Pharmaceutical form:Oral suspension -Route of administration:Oral or nasogastric tube
  • Belumosudil — DRUG
    Pharmaceutical form:Tablet formulation-Route of administration:Oral

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Jun 2026
Primary completion
Sep 25, 2028
Completion
Feb 28, 2031

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: belumosudil
    Participant will take IMP with a meal approximately the same time each morning. IMP dose will be according to weight and will be increased to daily dose of twice a day (BID) in participants who concomitantly receive proton pump inhibitors (PPIs) or strong CYP3A4 inducers. No concomitant PPIs are allowed during Phase 1 up to and including Cycle 1 Day 15. From Day 16 onwards, PPIs will be permitted, resulting in an increased dose of Belumosudil to BID. No concomitant strong CYP3A4 inducers are allowed during Phase 1.

Primary Outcome Measure

Phase 1: AUC [ Time Frame: Cycle 1 Day 15 after the last participant dosed in the phase 1 part. ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles- Site Number : 8400009Los AngelesCalifornia90027-
Children's National Medical Center - Washington- Site Number : 8400005Washington D.C.District of Columbia20010-
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001New YorkNew York10065-
Texas Children's Hospital- Site Number : 8400008HoustonTexas77030-
Fred Hutchinson Cancer Research Center- Site Number : 8400002SeattleWashington98109-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's National Medical Center - Washington· Washington D.C., DCMemorial Sloan Kettering Cancer Center - New York - York Avenue· New York, NYTexas Children's Hospital· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WA

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