NCT06616415CompletedPhase 4
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
A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
This is a single group, Phase 4, single-arm post-marketing study for treatment. The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies. Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 24 Sept 2024
- Start date
- 4 Dec 2024
- Primary completion date
- 12 May 2026
- Lead sponsor
- Sanofi
- NCT number
- NCT06616415
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 6
- From 4 Dec 2024 to the primary completion date, 12 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.
Other illness
- Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Lab values
- Absolute neutrophil count (ANC) \<1.0 × 10\^9/L.
- Platelet count \<50 × 10\^9/L.
- Alanine aminotransferase (ALT) \>3× the upper limit of normal (ULN), aspartate aminotransferase (AST) \>3 × ULN.
- Total bilirubin (TBIL) \>1.5 × ULN (\>3 ULN if Gilbert's syndrome).
- Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m\^2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m\^2) = 0.413 × (height \[in cm\])/Creatinine (in mg/dL) at screening visit.
Other
- Participants are excluded from the study if any of the following criteria apply:
Who the study is looking for
- Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
- Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Has active moderate to severe cGVHD.
- Has received at least one line of prior systemic therapy for cGVHD.
- Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.
- Has a Lansky-Play performance score of ≥60.
- Participants should have an expected survival of longer than 6 months.
- Body weight of 30 kg and above.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.