Topical Ruxolitinib in Acute Skin GVHD (Graft Versus Host Disease)
NCT07801248 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-09-03
Summary
The purpose of this study is to see if ruxolitinib, a Janus Kinase (JAK) 1/2 inhibitor, is safe for people who have acute skin graft versus host disease (GVHD) following allogenic hematopoietic stem cell transplantation (HSCT).
Conditions
- Acute Skin Graft Versus Host Disease (GVHD)
Interventions
- DRUG
-
Ruxolitinib 1.5% cream
Ruxolitinib is a Janus Kinase (JAK) 1/2 inhibitor. JAKs are intracellular tyrosine kinases that play an important role in the development and function of immune cells that are involved in the pathogenesis of acute GVHD. For this study, ruxolitinib cream will be manufactured by Incyte and stored and distributed by the investigational pharmacy at CCHMC using standard operating procedures. Ruxolitinib 1.5% cream will be applied as a thin film topically twice a day to areas of erythroderma and pruritus. Participants and guardians will receive an informational instruction sheet describing the amount, frequency, and technique of applying the cream. Patients may continue to use standard of care GVHD prophylaxis and moisturizers.
Sponsors & Collaborators
-
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Zahra Hudda, MD · Children's Hospital Medical Center, Cincinnati
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2029-10-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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