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Atopic DermatitisPhase 1NCT03920852

A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis

A Phase 1 study testing Ruxolitinib cream in people with Atopic Dermatitis, run by Incyte Corporation at 10 sites in 2 countries.

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 and blood levels after its topical application twice daily to affected areas (≥ 25% BSA) in adolescent and adult 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 12 to 65 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
41 participants
Where
10 sitesin 2 countries
Study dates
30 May 2019to 26 Dec 2019
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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosed with atopic dermatitis as defined by Hanifin and Rajka criteria.
  • Atopic dermatitis duration of at least 2 years.
  • Investigator's Global Assessment score of at least 2 at screening and baseline.
  • Body surface area of atopic dermatitis involvement of ≥ 25% at screening and baseline.
  • Agree to discontinue all agents used to treat atopic dermatitis from screening through the final follow up visit.
  • Willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of females of nonchildbearing potential and prepubescent adolescents.
  • Written informed consent of the participant or parent(s)/legal guardian and a verbal or written assent from the participant when possible.

Who cannot join

  • Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline.
  • Concurrent conditions and history of other diseases:
  • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 14 days (2 weeks) before the baseline visit.
  • Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 7 days (1 week) before the baseline visit.
  • Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome, or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.
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  • Other types of eczema.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full study participation, 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 periods before baseline:
  • 5 half-lives or 84 days (12 weeks), whichever is longer: biologic agents (eg, dupilumab).
  • 28 days (4 weeks): systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
  • 14 days (2 weeks) or 5 half-lives, whichever is longer: immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted); and potent systemic CYP3A4 inhibitors or fluconazole.
  • 7 days (1 week): other topical treatments applied onto atopic dermatitis skin lesions (other than bland emollients), such as corticosteroids, crisaborole, calcineurin inhibitors, coal tar (shampoo), antibiotics, antibacterial cleansing body wash/soap.
  • Treatment with Janus kinase inhibitors (systemic or topical) within 12 weeks (3 months) from baseline.
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (eg, sunlight or tanning booth) within 14 days (2 weeks) before baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's atopic dermatitis.
  • Positive serology test results at screening for HIV antibody.
  • Liver function test results outside the protocol-defined range.
  • Pregnant or lactating participants or those considering pregnancy.
  • History of alcoholism or drug addiction within 365 days (1 year) before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
  • Current treatment or treatment within 28 days (4 weeks) or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States9 sites

  • Orange County Research Center

    Anaheim, California, 92801

  • Oakland Hills Dermatology PC

    Auburn Hills, Michigan, 48326

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • Encino Research Center

    Encino, California, 91436

  • Clinical Research Institute of Southern Oregon - Crisor

    Medford, Oregon, 97504

  • RM Medical Research, INC.

    Miami, Florida, 33174

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Pure Skin Dermatology Aesthetics at Accel Research

    Orlando, Florida, 32819

  • Clinical Research Partners LLC

    Richmond, Virginia, 23220

Other trials in United States

Canada1 site

  • Innovaderm Research Inc.

    Montreal, Quebec, H2K 4L5

Other trials in Canada

About this study

This is an open-label maximum use trial to evaluate ruxolitinib safety and blood levels after its topical application twice daily to affected areas (≥ 25% BSA) in adolescent and adult participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.

Being tested
Ruxolitinib cream
Keywords
Atopic dermatitis, ruxolitinib cream, maximum use
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 NCT03920852
Study groupRoleWhat they receive
Ruxolitinib creamExperimentalNot described
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 127 days

Secondary outcomes (4)

  1. Plasma concentration of ruxolitinib

    Measured: Up to 127 days

  2. Cmax of ruxolitinib

    Maximum measured plasma concentration.

    Measured: Up to 127 days

  3. Tmax of ruxolitinib

    Time to achieve the observed maximum plasma concentration.

    Measured: Up to 127 days

  4. AUC0-12 of ruxolitinib

    Area under the concentration-time curve from 0 to 12 hours.

    Measured: Up to 127 days

Timeline

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

  1. First posted19 Apr 2019
  2. Study start30 May 2019
  3. Primary completion26 Dec 2019
  4. Study completion26 Dec 2019

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920852
Sponsor's protocol ID
INCB 18424-103
Status last verified
Feb 2020
First submitted
17 Apr 2019
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bissonnette R, Call RS, Raoof T, Zhu Z, Yeleswaram S, Gong X, Lee M. A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):355-364. doi: 10.1007/s40257-022-00690-3. Epub 2022 Apr 4.

    PubMed 35368221

  • Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

    PubMed 33658996

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 10 sites in 2 countries.

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 20 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. 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 127 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 NCT03920852, which also lists 2 linked publications.

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 17 Feb 2020.

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