NCT05305989

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

Detailed description

This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not be screened. Subjects who have signed the informed consent form will be enrolled in Study KD025-217 if they have met 1 of the following conditions: * Actively receiving belumosudil or in long-term follow-up (LTFU) in Study KD025-208 or Study KD025-213 * Enrolled in the Companion Study as specified in Study KD025-213 Amendment 2 and received at least 6 months of treatment or is in LTFU Approximately 20 Study Centers will participate with approximately 70 subjects participating overall.

Conditions

• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	Belumosudil 200 mg QD	Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
DRUG	Belumosudil 200 mg BID	Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
DRUG	Belumosudil 400 mg QD	Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.

Timeline

• Start date: 2022-02-23
• Primary completion: 2024-06-06
• Completion: 2024-06-06
• First posted: 2022-03-31
• Last updated: 2025-05-02
• Results posted: 2025-05-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study