Non-sclerotic Cutaneous Chronic Graft-versus-host DiseasePhase 2NCT03954236
Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
A Phase 2 study testing topical ruxolitinib 1.5% cream in people with Non-sclerotic Cutaneous Chronic Graft-versus-host Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Non-sclerotic Cutaneous Chronic Graft-versus-host Disease
- What is being tested?
- topical ruxolitinib 1.5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 12 Oct 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (≥ 12 years)
- History of allogeneic hematopoietic stem cell transplantation
- 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)
- Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and <18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
- Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
- If on systemic therapy for GVHD, systemic therapy must be stable for past 4 weeks; however, any planned systemic corticosteroid taper during the study will be permitted.Changes in systemic therapy during the study period will be allowed for the management of non-skin GVHD.
- Any concurrent topical therapies including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy must be discontinued on Study Day 0.
Who cannot join
- Known history of allergy to any ingredient of the study medication
- Patients with deep sclerotic cutaneous graft-versus-host disease including deep sclerotic subtypes of chronic cutaneous GVHD
- Use of concurrent topical therapy including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy after Study Day 0 up to and including Study Day 28.
- Changes in systemic therapy during study period for the purpose of treating skin GVHD.
- Special populations:
- vulnerable populations e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners
Show all 11Show fewer
- patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
- Concurrent participation in another topical trial of a drug(s) or medical device, or the subject is in an exclusion period after a previous trial of drug(s) or medical device
- Pregnancy or lactation
- Patients with inadequate liver function (ALT above 4 × upper limit of normal [ULN] for the patient's age or direct bilirubin 4 × ULN for the patient's age and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD (if direct bilirubin is not in the medical record, it is acceptable to use total bilirubin x4 ULN).
- Active uncontrolled infection requiring systemic therapy. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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
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.
- Being tested
- topical ruxolitinib 1.5% cream, Topical vehicle/moisturizer cream
- Keywords
- Ruxolitinib Cream, 18-412
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical ruxolitinib 1.5% creamDrug
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.
Topical vehicle/moisturizer creamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with graft-versus-host disease (GVHD) | Experimental | 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. Receives: Drug: topical ruxolitinib 1.5% cream; Other: Topical vehicle/moisturizer cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days (+/-3 days)
Secondary outcomes (1)
Improvement in Physician's Global Assessment of Clinical Condition (PGA) at From Day 1 and Day 28
The difference in the Physician's Global Assessment/PGA of non-sclerotic and superficially sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion (day 28 visit). Grade of Rash as follows: Grade 0, Clinical Complete Response, Completely clear; NED (100% improvement); Grade 1-3, Partial Response, from very significant clearance to moderate improvement (>90% to >/= 50% improvement); Grade 4 and 5, Stable Disease, No change to some improvement (,50% to >/=25%); Grade 6, Progressive Disease, Disease is worse than at baseline evaluation by >/= 25%.
Measured: 28 days (+/-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start14 May 2019
- Primary completion12 Oct 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-sclerotic Cutaneous Chronic Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hackensack Meridian Health, Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954236
- Sponsor's protocol ID
- 18-412
- Status last verified
- Oct 2026
- First submitted
- 15 May 2019
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42748944
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03954236
- Acronym / sponsor ID
- 18-412
- Keywords
- Ruxolitinib Cream, 18-412
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Hackensack Meridian Health, Incyte Corporation
- Study start
- 14 May 2019 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with graft-versus-host disease (GVHD) | Experimental | Drug: topical ruxolitinib 1.5% cream, Other: Topical vehicle/moisturizer creamParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients (≥ 12 years)
- History of allogeneic hematopoietic stem cell transplantation
- 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)
- Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and <18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
- Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
Key exclusion criteria (11 listed)
- Known history of allergy to any ingredient of the study medication
- Patients with deep sclerotic cutaneous graft-versus-host disease including deep sclerotic subtypes of chronic cutaneous GVHD
- Use of concurrent topical therapy including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy after Study Day 0 up to and including Study Day 28.
- Changes in systemic therapy during study period for the purpose of treating skin GVHD.
- Special populations:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical ruxolitinib 1.5% creamPatients 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. | Drug | Participants with graft-versus-host disease (GVHD) |
| Topical vehicle/moisturizer creamPatients 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. | Other | Participants with graft-versus-host disease (GVHD) |
Primary outcome
Reduction in Body Surface Area (BSA) From Day 1 and Day 28
Time frame: 28 days (+/-3 days)
The difference in BSA of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion
1 secondary outcome
Improvement in Physician's Global Assessment of Clinical Condition (PGA) at From Day 1 and Day 28
Time frame: 28 days (+/-3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42748944Markova 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topical ruxolitinib 1.5% cream in people with Non-sclerotic Cutaneous Chronic Graft-versus-host Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Body Surface Area (BSA) From Day 1 and Day 28 (time frame: 28 days (+/-3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.