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

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ClinicalTrials.gov Identifier: NCT03920852
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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 Intervention/treatment Phase
Atopic Dermatitis Drug: Ruxolitinib cream Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : May 17, 2019
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Ruxolitinib cream Drug: Ruxolitinib cream
Ruxolitinib 1.5% cream applied twice daily.
Other Name: INCB018424 phosphate cream




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. Plasma concentration of ruxolitinib [ Time Frame: Up to 127 days ]
  2. Cmax of ruxolitinib [ Time Frame: Up to 127 days ]
    Maximum measured plasma concentration.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920852


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, Florida
San Marcus Research Clinic, Inc. Not yet recruiting
Miami Lakes, Florida, United States, 33014
RM Medical Research, INC. Not yet recruiting
Miami, Florida, United States, 33174
United States, Texas
Progressive Clinical Research, P.A. Not yet recruiting
San Antonio, Texas, United States, 78213
United States, Virginia
Clinical Research Partners Not yet recruiting
Richmond, Virginia, United States, 23220
Canada, Quebec
Innovaderm Research Inc. Not yet recruiting
Montréal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Michael E. Kuligowski, MD Incyte Corporation

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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: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases