Observational Study of Axatilimab for Skin cGVHD

This study is looking at how axatilimab affects immune cells in the skin and blood of people with chronic graft-versus-host disease (cGVHD) that affects the skin. cGVHD is a condition that can happen after a stem cell transplant, where donor immune cells attack your body's tissues. Axatilimab is an FDA-approved medicine for cGVHD. Researchers want to understand how axatilimab changes specific immune cells called macrophages in your skin. You may be able to join if you are 18 or older, have cGVHD with skin involvement, and are either starting axatilimab or not. The study will measure changes in certain immune cells in your skin to see how the medicine works. The current status of this study is unclear, and it plans to enroll 15 participants.

Study design
This is an observational study, meaning researchers will watch how axatilimab is used in routine care. It plans to include 15 participants.
What's involved
You would need to undergo a skin biopsy at the start of the study. Your skin will be checked at Baseline, Week 2, and Week 12.
Compensation
Not stated in the trial record.
Follow-up
Your skin will be checked at Baseline, Week 2, and Week 12 to see changes in immune cells.

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NCT07728708

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

Not Yet Recruiting
Not specifiedAges 18+Observational
Northwestern University
~15 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Axatilimab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in CSF1R+ profibrotic macrophages in skin
Measured over Baseline, Week 2, and Week 12
Chronic Graft vs. Host Disease
GVHD
cGVHD
Graft Versus Host Disease in Skin
1 sites across 1 states
Illinois1
  • Alexander Misharin, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Kehinde Adekola, MD · PRINCIPAL_INVESTIGATOR · Northwestern University

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Eligibility criteria

Inclusion

Age 18 years or older.
Diagnosis of chronic graft-versus-host disease (cGVHD) with skin involvement.
Planned initiation of axatilimab as part of routine clinical care (axatilimab arm) or not planning initiation of axatilimab as part of routine clinical care (control arm).
Able to undergo a skin biopsy at the time of enrollment.
Able to provide informed consent.

Exclusion

Unable to provide informed consent.
Contraindication to skin biopsy, including severe thrombocytopenia or other conditions that make skin biopsy unsafe in the judgment of the investigator.
Active uncontrolled infection.
  • Change in CSF1R+ profibrotic macrophages in skinBaseline, Week 2, and Week 12

    Within-participant change in the abundance and activation state of CSF1R-positive profibrotic macrophages in skin biopsy specimens after initiation of axatilimab.