Trial · NCT06616415
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
NCT06616415, Phase 4, Completed, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies. Trials, record NCT06616415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06616415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
- NCT number
- NCT06616415
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Chronic Graft Versus Host Disease
- Interventions
- Belumosudil
- First posted
- 2024-09-27
- Last updated
- 2026-05-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma concentrations of belumosudil at specified time points | At Day 1 and Day 29(±3) | |
| Secondary | Overall response rate (ORR) | Up to 18 month | Overall response rate (ORR, including complete response \[CR\] and partial response \[PR\]), which will be assessed by the investigator according to the NIH Consensus Criteria (2014) at any time before the start of new systemic treatment for cGVHD. |
| Secondary | Duration of response (DoR) | Up to 18 month | Duration of response (DoR): time from the date of the first response to the date of cGVHD progression as defined by 2014 NIH consensus response criteria, start of new systemic treatment for cGVHD, or death, whichever occurs first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH consensus response criteria. |
| Secondary | System organ response rate | Up to 18 month | System organ response rate: proportion of participants who achieve an overall response (CR or PR) for each of the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD |
| Secondary | Number and proportion of participants with dose reduction in corticosteroid during the treatment period | Up to 18 month | |
| Secondary | Failure-free survival (FFS) | Up to 18 month | Failure-free survival (FFS): time from the date of the first administration of IMP to 1) the date of initiation of new systemic treatment for cGVHD, or 2) date of death, or 3) date of recurrent underlying disease, whichever occurs first |
| Secondary | Overall survival (OS) | Up to 18 month | Overall survival (OS): time from the date of the first administration of IMP to the date of death due to any cause |
| Secondary | Change in cGVHD severity based on physician-reported overall cGVHD activity | Up to 18 month | |
| Secondary | Change in symptom activity assessed based on patient-reported cGVHD activity | Up to 18 month | |
| Secondary | Modified Lee cGVHD Symptom Scale change | Up to 18 month | The scale contains 30 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Patients report how "bothered" they feel about each symptom using a five-point Likert scale from "not at all" (0) to "extremely" (4). A higher score indicating worse symptoms, reporting score will be normalizing to a 0 to 100 scale. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT06616415
GET https://conductscience.org/api/trials/v1/NCT06616415/registered