NCT02841995

A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

A Phase 2a, Dose-Escalation, Open-Label Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host disease (cGVHD).

Detailed description

Fifty four (54) participants were enrolled to receive orally administered belumosudil 200 milligrams (mg) once daily (QD), belumosudil 200 mg twice daily (BID), or belumosudil 400 mg QD. Study drug was administered in 28-day cycles until disease progression or occurrence of unacceptable toxicity. Participants received study drug in the inpatient or outpatient setting.

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
DRUG	Belumosudil (KD025)	Pharmaceutical form: Capsules or Tablets Route of administration: Oral

Timeline

• Start date: 2016-09-15
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2016-07-22
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study