A Pilot, Prospective, Randomized, Double-Blinded, Vehicle- and Comparator-Controlled Trial on Safety and Efficacy of a Topical Inhibitor of Janus Kinase 1/2 (Ruxolitinib INCB018424 Phosphate 1.5% Cream) for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
Sponsor study identifier
interventional
24
1 country
1
Study Start
May 14, 2019
Actual (reported)Primary Completion
October 12, 2026
Actual (reported)Study Completion
October 12, 2026
Actual (reported)The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2019
Actual (reported)May 15, 2019
Actual (reported)May 17, 2019
Actual (reported)February 10, 2026
Actual (reported)October 12, 2026
Actual (reported)October 12, 2026
Actual (reported)Reduction in Body Surface Area (BSA) From Day 1 and Day 28
The difference in BSA of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion
28 days (+/-3 days)
Improvement in Physician's Global Assessment of Clinical Condition (PGA) at From Day 1 and Day 28
28 days (+/-3 days)
Participants will have non-sclerotic chronic cutaneous graft-versus-host disease (GVHD) or you have a condition called superficially sclerotic chronic cutaneous graft-versus-host disease (GVHD) after having received an allogeneic hematopoietic stem cell transplant.
Patients will be prescribed twice daily use of topical ruxolitinib 1.5% cream (randomized half of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days. Topical ruxolitinib will be provided as topical cream. At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
topical ruxolitinib 1.5% cream
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
topical ruxolitinib 1.5% cream
Named ingredient: ruxolitinib
View registry recordMemorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Markova A, Ostojic J, Rotemberg V, Nykaza I, Kanbar J, Papadopoulos EB, Dusza S, Ai R, Maier T, Lacouture ME, Tamari R, Shaffer BC, Scordo M, Perales MA, Harris A, Ponce DM. Topical ruxolitinib for chronic cutaneous graft-versus-host disease: a single-centre, randomised, double-blind, intra-patient-controlled phase 2 trial. Lancet Haematol. 2026 Sep 16:S2352-3026(26)00201-2. doi: 10.1016/S2352-3026(26)00201-2. Online ahead of print.
Alina Markova, MD
Memorial Sloan Kettering Cancer Center
24 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
May 14, 2019
Actual (reported)Primary Completion
Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment
Patients will be prescribed twice daily use of vehicle/moisturizer (for contralateral side of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days.At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.
Contact the study team to confirm eligibility.
October 12, 2026
Actual (reported)Study Completion
October 12, 2026
Actual (reported)Last Updated
October 29, 2026
Results First Posted
February 10, 2026
Record last verified: 2026-10
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Source: ClinicalTrials.gov.
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