Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07011810 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

StatusRecruiting
PhasePhase 2
Started2025-08-06
View on ClinicalTrials.gov ↗

Amendment history

2026-08-11
Study Status, Eligibility v6
Eligibility criteria+328 characters
[...] inical trials in cGVHD Sclerotic skin score 2-3 or PROM < 24 or Joints/Fascia score 2-3 due to cGVHD Initial diagnosis of sclerosis within the past 2412 weeksmonths. For (168example, days)if a patient is diagnosed with sclerosis on 01/01/2026, they remain eligible through 01/01/2027 No new non-corticosteroid systemic immunosuppressive agent [...] least 60 days and the sclerotic cGVHD either did not respond, progressed, or progressedinitially improved but has not continued to improve in the last 6 weeks; (b) the systemic immunosuppressive treatment(s) were given [...] ith positive HCV ribonucleic acid [RNA] [...]
2026-03-25
Study Status, Eligibility v5
Eligibility criteria-8 characters
[...] Gilbert's disease Estimated creatinine clearance ≥ 30 mL/min/1.73m^2 based on the institutional formula Male and female particip [...]
2026-01-06
Study Status v4
Start date2025-07-31→2025-08-06
2025-08-05
Study Status v3
Start dateestimated 2025-09-01→confirmed 2025-07-31
2025-07-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 3 of 3 sites
2025-06-11
Study Status v1
Re-verified, no change to tracked fields
2025-06-02
Original filing
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.
Trial Details
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 2026-09-24