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Janus Kinase (JAK) Inhibitor

Topical Ruxolitinib for Cutaneous Chronic Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Alina Markova, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BSA of at least 2% of clinically or histologically confirmed non-sclerotic cutaneous chronic graft-versus-host disease (diagnosed and BSA calculated in accordance with the National Institutes of Health Chronic Graft-versus-Host Disease Consensus for Clinical Trials: I. The 2014 Diagnosis and Staging Working Group Report)

History of allogeneic hematopoietic stem cell transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days (+/-3 days)

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new medication, ruxolitinib cream, to standard moisturizers in people with a skin condition called non-sclerotic chronic GVHD.

Who is the study for?

Adults and minors (12+) who have had a stem cell transplant and are now dealing with non-sclerotic chronic skin GVHD can join. They must not be using other skin treatments, their systemic therapy should be stable for 4 weeks, and they need to apply the cream themselves or get help doing so.Check my eligibility

What is being tested?

The trial is testing Ruxolitinib cream against standard moisturizers to see which is better for treating chronic skin issues caused by graft-versus-host disease after a stem cell transplant.See study design

What are the potential side effects?

Possible side effects of Ruxolitinib cream may include local skin reactions like redness, itching, or irritation at the site where it's applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a skin condition from a transplant affecting at least 2% of my body.

Select...

I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days (+/-3 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days (+/-3 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (+/-3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the difference in body surface area (BSA) of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion

Trial Design

2Treatment groups

Experimental Treatment

Group I: topical ruxolitinib BID to right side of face/bodyExperimental Treatment2 Interventions

And topical moisturizer BID to left side of face/body.

Group II: topical ruxolitinib BID to left side of face/bodyExperimental Treatment2 Interventions

And topical moisturizer BID to right side of face/body.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

topical ruxolitinib 1.5% cream

2019

Completed Phase 2

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,141 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,598 Total Patients Enrolled

Hackensack Meridian HealthOTHER

131 Previous Clinical Trials

28,220 Total Patients Enrolled

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03954236 — Phase 2

Cutaneous Chronic Graft-versus-Host Disease Research Study Groups: topical ruxolitinib BID to left side of face/body, topical ruxolitinib BID to right side of face/body

Cutaneous Chronic Graft-versus-Host Disease Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT03954236 — Phase 2

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03954236 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participants of this research?

"Affirmative, as per the information on clinicaltrials.gov, this research is in search of individuals to participate. The original listing was put up on May 14th 2019 and most recently updated on October 3rd 2022. To date, 24 volunteers are needed for a single trial location."

Answered by AI

To what extent has enrollment been opened for this clinical experiment?

"Accurate. Data hosted on clinicaltrials.gov confirms that this medical study, which was initially posted in May 14th 2019, is currently enrolling patients. 24 individuals are needed to be recruited from the single available location."

Answered by AI

Has the FDA accepted ruxolitinib 1.5% cream for public use?

"According to our estimation, the topical form of ruxolitinib 1.5% cream is moderately safe based on prior Phase 2 data collection which has provided evidence that supports safety but not efficacy."

Answered by AI

What clinical indications is topical ruxolitinib 1.5% cream typically administered for?

"Ruxolitinib 1.5% cream is the commonly prescribed treatment for polycythemia vera, and can be helpful in managing other ailments such as resistance to or intolerance of hydroxyurea, primary myelofibrosis, and polycythemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

2019. "Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03954236.