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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Belumosudil	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-05-13
• Completion: 2026-05-13
• First posted: 2024-09-27
• Last updated: 2025-06-22

Locations

2 sites across 1 country: China