Topical Ruxolitinib in Acute Skin GVHD (Graft Versus Host Disease)

Conditions

• Acute Skin Graft Versus Host Disease (GVHD)

Eligibility Criteria

Sex

ALL

Age

2 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib 1.5% cream — DRUG
  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.

Study Details

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).

Key Dates

First listed

Sep 3, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2029

Completion

Oct 31, 2029

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib
  Ruxolitinib 1.5% cream will be applied topically twice a day to areas of erythroderma and pruritus.

Primary Outcome Measure

Number of patients with a clinical response at Day 7 (± 3 days) [ Time Frame: From enrollment to Day 7 (± 3 days) ]

Central Contacts

• Monica Trapp, BSN, RN, TCTCN
  513-803-8574
  [email protected]

Locations (1)

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