drugset / Trial / NCT05567406

Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

NCT05567406

Phase 2 Withdrawn Kadmon, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above. The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

Timeline

Start
2025-06-16
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Belumosudil Small molecule Oral