ClinicalTrials.gg
Not yet recruitingNCT07801248Updated Nov 12, 2026

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

A Phase 1 interventional study of Ruxolitinib 1.5% cream in Acute Skin Graft Versus Host Disease (GVHD), sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1, Interventional, and Treatment

Updated Nov 12, 2026Start date movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
2 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies testing ruxolitinib in Graft vs Host Disease — 13 open to participants now, 16 under way, 2 of them phase 3. ruxolitinib · Graft vs Host Disease.

Planned enrollment
25th of 27
10 · median 54
Started
2028
the only one that year
Phase 1
3 of 27
3 open now
Primary completion
2029-10
later than 12 of 15 live
Registered
26th of 27
by date
Lead sponsor
1 of 27
Children's Hospital Medical Center, Cincinnati

Among the 27 studies testing ruxolitinib in Graft vs Host Disease, this one is the 25th largest by planned enrollment, is the only one that started in 2028, is one of 3 in phase 1, reaches primary completion later than 12 of the 15 other live ones, and was the 26th registered.

Graft vs Host Disease

804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.

Browse Graft vs Host Disease studies →

Open to participants now

13 of the 27 studies testing ruxolitinib in Graft vs Host Disease are open now, in 12 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

About ruxolitinib

ruxolitinib: first FDA approval 2011 (JAKAFI), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.

This study: 2 Years to 35 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies testing ruxolitinib in Graft vs Host Disease, or all of them as a file.
02

Study 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).

Read the detailed description

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). This is a single arm, open-label pilot study. There is no randomization. This study will enroll approximately 10 patients with underlying malignancies with acute skin GVHD. Participants will be treated with topical ruxolitinib for 28 days or until the end of treatment if earlier resolution of GVHD is achieved.

03

Conditions studied

  • Acute Skin Graft Versus Host Disease (GVHD)

Browse trials for

04

Who can participate

Ages eligible
2 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥2 through age 35 years
  • Acute skin (any grade).
  • Underlying diagnosis of .
  • No concurrent systemic immune suppression to treat acute GVHD. This excludes agents like calcineurin inhibitors, mycophenolate mofetil, and abatacept which prevent acute GVHD and are not used for treatment as per clinical practice may continue.
  • Use of prior topical or topical tacrolimus will be allowed but these will need to be discontinued 24 hours prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

  • Active uncontrolled skin infections.
  • History of allergic reactions to topical ruxolitinib.
  • Concomitant or have received therapies within the previous 30 days.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Ruxolitinib

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

    Drug: Ruxolitinib 1.5% cream

Interventions

  • 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 Cincinnati Children's Hospital Medical Center (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.

06

What researchers measure

Primary outcomes

  1. Number of patients with a clinical response at Day 7 (± 3 days)

    Participants will be evaluated by monitoring the clinical response, tolerability and safety of topical ruxolitinib at Day 7 (± 3 days). Patients who respond by Day 7 (± 3 days) will continue treatment until resolution of symptoms or till Day 28 (± 3 days).

    Time frame: From enrollment to Day 7 (± 3 days)

  2. Number of patients with a clinical response at Day 28 (± 3 days)

    Participants will be evaluated by monitoring the clinical response, tolerability and safety of topical ruxolitinib at Day 28 (± 3 days).

    Time frame: From enrollment to Day 28 (± 3 days)

Secondary outcomes

  1. Number of patients needing systemic immune suppression due to lack of response from progressive symptoms or adverse events secondary to topical ruxolitinib

    Time frame: From enrollment to Day 28 (± 3 days)

  2. Number of patients with a relapse of primary malignancy by 1 year post HSCT

    Time frame: From enrollment to 1 year post HSCT

  3. Blood ruxolitinib concentration levels at documented body surface area (BSA) applications and their association with adverse effects and relapse rates.

    Time frame: Day 7 (± 3 days)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2028; primary completion for Oct 2029, 21 months later.

Of 39 non-industry phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's planned 21 months is below that.

Counting every sponsor, half of 49 studies reached it within 47 months; a quarter within 24 and three quarters within 65.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Jan 2028, on Nov 12, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 3, 2026
StartEst.
Jan 1, 2028was Oct 2026
Primary completionEst.
Oct 2029
CompletionEst.
Oct 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 1, 2026→Jan 1, 2028
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Start date Oct 1, 2026→Jan 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07801248
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Jan 1, 2028 (estimated)
Primary completion
Oct 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Monica Trapp, BSN, RN, TCTCN
Contact
monica.trapp@cchmc.org
513-803-8574
Zahra Hudda, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Ruxolitinib

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