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Atopic DermatitisPhase 1NCT05034822

Study of Ruxolitinib Cream in Children With Atopic Dermatitis

A Phase 1 study testing Ruxolitinib cream in people with Atopic Dermatitis, run by Incyte Corporation at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in pediatric participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events. Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Ruxolitinib cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
15 sitesUnited States
Study dates
16 Dec 2021to 7 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male and female children aged ≥ 2 years to < 12 years (age at the screening visit).
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
  • AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior to screening).
  • An IGA score as follows:
  • Treatment period: ≥ 2 at the screening and baseline visits.
  • LTS period: 0 to 4 at Week 8
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  • %BSA (excluding the scalp) with AD involvement as follows:
  • Treatment period: ≥ 35% at screening and baseline
  • LTS period: 0% to 20% at Week 8
  • For children aged 6 years to < 12 years, mean Itch NRS score ≥ 4 during the screening period.
  • Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
  • At least 1 target lesion that measures approximately 5 cm2 or more at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the face, hands, feet, or genitalia.
  • For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of male and female participants who are prepubescent.
  • Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible.

Who cannot join

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to the baseline visit.
  • Concurrent conditions and history of other diseases as follows:
  • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,
  • Wiskott-Aldrich syndrome) or a history of malignant disease within 5 years before the baseline visit.
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
  • Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 1 week before the baseline visit.
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  • Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.
  • Other types of eczema.
  • Chronic asthma requiring more than 800 μg/day of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • A medical history of hepatitis B virus or hepatitis C virus infection.
  • Any participant on maintenance dialysis.
  • Any of the following clinical laboratory test results at screening:
  • Cytopenias at screening, defined as follows:
  • Hemoglobin < 10 g/dL
  • ANC < 1000/µL
  • Platelet count < 100,000/µL
  • Liver function tests:
  • AST or ALT ≥ 2.5 × ULN
  • Total bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%).
  • Estimated GFR < 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease equation)
  • Positive serology test results at screening for HIV antibody.
  • Any other clinically significant laboratory result that, in the opinion of the investigator, pose a significant risk to the participant
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Use of any of the following treatments within the indicated washout period before the baseline visit:
  • 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
  • 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate, choroquine or tacrolimus).
  • 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live-attenuated vaccines are not recommended during the treatment period of the study. COVID-19 vaccines are allowed during the study.
  • 1 week - use of topical treatments for AD (other than bland emollients, creams, ointments, sprays, soap substitutes), topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week.
  • Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
  • Known or suspected hypersensitivity to either ruxolitinib or any component of its cream vehicle.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
  • Inadequate venous access in nonlesional areas for laboratory blood draws.
  • In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Orange County Research Center

    Anaheim, California, 92801

  • Oakland Hills Dermatology Pc

    Auburn Hills, Michigan, 48326

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Desert Sky Dermatology

    Gilbert, Arizona, 85295

  • Cyn3Rgy Research - Clinedge - Ppds

    Gresham, Oregon, 97030

  • Skin Care Research, Llc Scr Hollywood

    Hollywood, Florida, 33021

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Accel Clinical Research

    Lake Mary, Florida, 32746

  • San Marcus Research Clinic Inc.

    Miami Lakes, Florida, 33014

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Advanced Medical Research Pc

    Sandy Springs, Georgia, 30328

  • Aeroallergy Research Lab of Savannah

    Savannah, Georgia, 31406

  • Forward Clinical Trials

    Tampa, Florida, 33624

Other trials in United States

About this study

Official title: A Maximum Use (MUsT) Pediatric Study of 1.5% Ruxolitinib Cream in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

This is an open-label maximum use trial to evaluate ruxolitinib safety, tolerability and blood levels after its topical application twice daily to affected areas (≥ 35% BSA) in pediatric participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.

Read the detailed description

Open-label, BID application to all affected areas identified at BSLN for 4 weeks (maximum use trial (MUsT) period). The next 4 weeks (treatment extension period) will be applied BID to active lesions only for the next 4 weeks for a total treatment period of 8 weeks. Eligible participants will be offered option to continue into 44-wk LTS period of BID to treat as-needed to active lesions. All participants will have 30 day safety follow-up visit.

Being tested
Ruxolitinib cream
Keywords
pediatric, Atopic dermatitis, ruxolitinib cream, maximum use, open label
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ruxolitinib creamDrug

    Also called INCB018424 phosphate cream

    Ruxolitinib 1.5% cream applied twice daily.

Study groups in NCT05034822
Study groupRoleWhat they receive
Ruxolitinib creamExperimentalruxolitinib 1.5% cream will be applied twice daily to all areas of the skin affected by AD
Receives: Drug: Ruxolitinib cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment-emergent adverse events

    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug

    Measured: Up to approximately 61 weeks

Secondary outcomes (3)

  1. Concentration of Ruxolitinib in plasma

    Measured: Day 1, Weeks 2, 4 and 8

  2. Plasma Css of Ruxolitinib

    Time to reach steady state concentration plateau of topical application under maximum use conditions

    Measured: Weeks 2 and 4

  3. Accumulation ratio of Ruxilitinib

    Accumulation ratio of ruxolitinib between plasma concentrations at 1 hour post application will be calculated and summarized in the age group of 7 to 11 years

    Measured: Day 1, Weeks 2, 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start16 Dec 2021
  3. Primary completion7 Aug 2023
  4. Study completion7 Aug 2023

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05034822
Sponsor's protocol ID
INCB 18424-109
Status last verified
Sep 2023
First submitted
30 Aug 2021
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stein Gold L, Bissonnette R, Forman S, Zaenglein A, Kuo Y, Angel B, Chen X, Kallender H, Paller AS. A Maximum-Use Trial of Ruxolitinib Cream in Children Aged 2-11 Years with Moderate to Severe Atopic Dermatitis. Am J Clin Dermatol. 2025 Mar;26(2):275-289. doi: 10.1007/s40257-024-00909-5. Epub 2025 Jan 6.

    PubMed 39760983

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ruxolitinib cream in people with Atopic Dermatitis, run by Incyte Corporation at 15 sites 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 14 inclusion and 34 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of treatment-emergent adverse events (time frame: Up to approximately 61 weeks). 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 NCT05034822, 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 15 Sep 2023.

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