A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy
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.
• Participants are included in the study if any of the following criteria apply:
• Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
• Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
• Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
• Have persistent cGVHD manifestations and systemic therapy is indicated.
• Karnofsky (if aged ≥ 16 years) / Lansky (if aged \< 16 years) Performance Score of ≥ 60.
• At least 12 years of age; weight ≥ 40 kilograms (kg).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
• Total bilirubin ≤ 1.5 x ULN.
• Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants
• Capable of giving signed informed consent.