Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

This phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.

NCT Number	NCT07011810
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: Incyte Corporation
Conditions	Chronic Graft Versus Host Disease
Enrollment	50 participants
Start Date	2025-08-06
Primary Completion	2028-08-10 (estimated)
Study Completion	2030-02-10 (estimated)
Updated on ClinicalTrials.gov	2026-08-12