Effects of Axatilimab on Skin in Chronic Graft-versus-Host Disease

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07728708
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Chronic Graft vs. Host Disease
  • GVHD
  • Graft Versus Host Disease in Skin
  • cGVHD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axatilimab — DRUG
    Axatilimab is an FDA-approved monoclonal antibody that blocks colony-stimulating factor-1 receptor (CSF1R). In this observational study, axatilimab is prescribed and administered as part of routine clinical care by the treating physician. The study does not assign or administer treatment; it evaluates biological changes associated with axatilimab therapy using skin biopsies, blood samples, and clinical assessments.

Study Details

Chronic graft-versus-host disease (cGVHD) is a condition that can develop after a stem cell transplant. It occurs when donor immune cells attack the body's tissues. In many people, cGVHD affects the skin, causing inflammation, thickening, and scarring that can limit movement and reduce quality of life. Axatilimab is a medicine approved by the U.S. Food and Drug Administration (FDA) to treat adults with cGVHD after at least two previous treatments have not worked well enough. Although axatilimab can improve cGVHD, researchers do not fully understand how it changes immune cells in the skin. The purpose of this study is to learn how axatilimab affects immune cells in the skin and blood of people with cGVHD. Researchers will study skin and blood samples collected before and after participants start axatilimab. The goal is to better understand how the medicine reduces inflammation and scarring and to identify biological changes that occur during treatment. This is an observational research study. The study does not decide whether participants receive axatilimab, when treatment starts, or what dose they receive. All treatment decisions are made by the participant's treating physician as part of routine medical care. About 15 adults with cGVHD involving the skin will participate. Ten participants who are starting axatilimab as part of their usual care will have three study visits: before treatment begins, about 2 weeks after starting treatment, and about 12 weeks after starting treatment. At each visit, participants will provide a small skin biopsy and a blood sample. Five participants with cGVHD who are not receiving axatilimab will serve as a comparison group and will complete one study visit with one skin biopsy and one blood sample. Researchers will also review participants' medical records and collect information about their skin disease over time. Information from this study may help researchers better understand how axatilimab works in people with cGVHD. The findings may also help improve future research and guide the development of treatments for cGVHD and other diseases that cause tissue scarring.

Key Dates

First listed
Jul 27, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Axatilimab arm
    Participants with chronic graft-versus-host disease (cGVHD) involving the skin who are initiating axatilimab as part of routine clinical care. This is an observational study; axatilimab is prescribed by the treating physician independent of study participation and is not administered by the study protocol. Participants will undergo study evaluations before starting treatment and approximately 2 and 12 weeks after treatment initiation. Study procedures include skin biopsies, blood collection, review of medical records, and clinical assessment of skin disease to evaluate biological changes associated with axatilimab treatment.
  • Arm: Control arm
    Participants with mild or controlled chronic graft-versus-host disease (cGVHD) involving the skin who are not initiating axatilimab and are receiving standard clinical management without CSF1R-targeted therapy. This observational comparison group will complete one study visit that includes a skin biopsy, blood collection, review of medical records, and clinical assessment of skin disease. Data and biospecimens from this group will provide a reference for comparison with participants receiving axatilimab to help distinguish biological changes associated with treatment from those associated with chronic cGVHD itself.

Primary Outcome Measure

Change in CSF1R+ profibrotic macrophages in skin [ Time Frame: Baseline, Week 2, and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611-

Find similar trials in Chicago, IL

By research site
Northwestern Medicine· Chicago, IL

Related Studies