Trial · NCT07116031
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
NCT07116031, Phase 2, Recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK). Trials, record NCT07116031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07116031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
- NCT number
- NCT07116031
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Chronic Graft Versus Host Disease
- Interventions
- Belumosudil, Belumosudil
- First posted
- 2025-08-11
- Last updated
- 2026-09-22
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: AUC | Cycle 1 Day 15 after the last participant dosed in the phase 1 part. | PK parameter (AUC at steady state) |
| Primary | Proportion of participants who achieve an overall response (partial response [PR] or complete response [CR]) by Week 25 or Cycle 7 Day 1 whichever is first | Last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study | Proportion of participants who achieve an overall response (partial response \[PR\] or complete response \[CR\]) with up to 24 weeks of therapy (i.e. by the Week 25 or Cycle 7 Day 1 visit whichever is first), as defined by the National Institute of Health (NIH) Consensus response criteria |
| Secondary | Phase 1: Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Up to 3 years after the last participant enrolled | Safety |
| Secondary | Phase 1: Cmax | Cycle 1 Day 15 after the last participant dosed in the phase 1 part | Steady-state belumosudil PK parameters |
| Secondary | Phase 1: AUC0-6h | Cycle 1 Day 15 after the last participant dosed in the phase 1 part | Steady-state belumosudil PK parameters |
| Secondary | Phase 1: ORR | last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study. | Proportion of participants who achieve an overall response (complete response \[CR\] or partial response \[PR\]) by 24 weeks, as defined by the 2014 National Institute of Health (NIH) Consensus response criteria |
| Secondary | Phase 1: DOR | Up to 3 years after the last participant enrolled | Time from the date of first response to the date of progression of cGVHD, initiation of a new systemic treatment for cGVHD, or death, whichever comes first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH Consensus response criteria |
| Secondary | Phase 1: response by organ | Up to 3 years after the last participant enrolled | As defined by the 2014 NIH Consensus response criteria |
| Secondary | Phase 1: failure-free survival (FFS) | Up to 3 years after the last participant enrolled | Time from the date of the first investigational medicinal product (IMP) administration to the date of initiation of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first |
| Secondary | Phase 1: overall survival (OS) | Up to 3 years after the last participant enrolled | Time from the date of first IMP administration to the date of death due to any cause |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07116031
GET https://conductscience.org/api/trials/v1/NCT07116031/registered