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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03920852

Recruitment Status Completed

First Posted April 19, 2019

Last update posted February 17, 2020

Study Description

Brief 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.

  • Condition or Disease:Atopic Dermatitis
  • Intervention/Treatment: Drug: Ruxolitinib cream
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 41 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Ruxolitinib cream
Drug: Ruxolitinib cream
Ruxolitinib 1.5% cream applied twice daily.
Outcome Measures
  • Primary Outcome Measures: 1. Number of treatment-emergent adverse events [ Time Frame: Up to 127 days ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug.
  • Secondary Outcome Measures: 1. Cmax of ruxolitinib [ Time Frame: Up to 127 days ]
    Maximum measured plasma concentration.
  • 2. Plasma concentration of ruxolitinib [ Time Frame: Up to 127 days ]
  • 3. Tmax of ruxolitinib [ Time Frame: Up to 127 days ]
    Time to achieve the observed maximum plasma concentration.
  • 4. AUC0-12 of ruxolitinib [ Time Frame: Up to 127 days ]
    Area under the concentration-time curve from 0 to 12 hours.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 65 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.

Contacts and Locations
Contacts
Locations

United States, California
Orange County Research Center
Anaheim

United States, California
Encino Research Center
Encino

United States, Florida
San Marcus Research Clinic, Inc.
Miami Lakes

United States, Florida
RM Medical Research, INC.
Miami

United States, Florida
Pure Skin Dermatology Aesthetics at Accel Research
Orlando

United States, Massachusetts
Metro Boston Clinical Partners
Brighton

United States, Michigan
Oakland Hills Dermatology PC
Auburn Hills

United States, Oregon
Clinical Research Institute of Southern Oregon - Crisor
Medford

United States, Virginia
Clinical Research Partners LLC
Richmond

Canada, Quebec
Innovaderm Research Inc.
Montréal

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director: Michael E. Kuligowski, MD Incyte Corporation

More Information
  • Responsible Party: Incyte Corporation
  • ClinicalTrials.gov Identifier: NCT03920852 History of Changes
  • Other Study ID Numbers: INCB 18424-103
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: February 17, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Incyte Corporation: Atopic dermatitis
    ruxolitinib cream
    maximum use
  • Additional relevant MeSH terms: Dermatitis, Atopic
    Dermatitis
    Eczema