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NCT07116031 · ClinicalTrials.gov registry record · Phase 2
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
A Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT07116031 is a Phase 2 study of Chronic Graft Versus Host Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 37 participants, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT07116031, a Phase 2 study of Chronic Graft Versus Host Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
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. 4 weeks of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.
Conditions Studied
Interventions
- DRUG Belumosudil
Study Locations (20)
Other
- Investigational Site Number : 0560003 - Ghent
- Investigational Site Number : 0560001 - Leuven
- Investigational Site Number : 1560003 - Beijing
- Investigational Site Number : 1560001 - Shanghai
- Investigational Site Number : 1560004 - Shenzhen
- Investigational Site Number : 1560002 - Suzhou
- Investigational Site Number : 2500002 - Marseille
- Investigational Site Number : 2500001 - Paris
- Investigational Site Number : 2760001 - Berlin
- Investigational Site Number : 3760005 - Haifa
- Investigational Site Number : 3760002 - Jerusalem
- Investigational Site Number : 3760004 - Petah Tikva
- Investigational Site Number : 3760003 - Ramat Gan
- Investigational Site Number : 3760001 - Tel Aviv
- Investigational Site Number : 5280001 - Utrecht
New York
- Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001 - New York
Texas
- Texas Children's Hospital- Site Number : 8400008 - Houston
Ontario
- Investigational Site Number : 1240002 - Toronto
Roma
- Investigational Site Number : 3800001 - Rome
Barcelona [Barcelona]
- Investigational Site Number : 7240003 - Esplugues de Llobregat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2025-12-02 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116031
The ClinicalTrials.gov registry entry for NCT07116031 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (68% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Belumosudil is the first listed.
NCT07116031 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT07116031 about?
NCT07116031 is a clinical study titled "A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)". 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...
What is the current status of trial NCT07116031?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2025-12-02. Estimated completion is 2031-02-28.
What conditions does trial NCT07116031 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT07116031?
The interventions under investigation include: Belumosudil (DRUG).
Who is sponsoring clinical trial NCT07116031?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07116031 being conducted?
This trial has 20 study locations across New York, Texas, Ontario, Roma, Barcelona [Barcelona]. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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