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A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03257644
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Ruxolitinib phosphate cream Phase 1

Detailed Description:
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cohort 1
Ruxolitinib phosphate cream 0.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424

Experimental: Cohort 2
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424

Experimental: Cohort 3
Ruxolitinib phosphate cream 0.75%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424

Experimental: Cohort 4
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424

Experimental: Cohort 5
Ruxolitinib phosphate cream 0.75%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424

Experimental: Cohort 6
Ruxolitinib phosphate cream 1.5%.
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Name: INCB018424




Primary Outcome Measures :
  1. Participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks. ]
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first application of study drug.


Secondary Outcome Measures :
  1. Plasma concentrations of ruxolitinib for Cohorts 1 and 2 [ Time Frame: Day 1, Day 15, and Day 29 ]
    Venous blood samples will be collected to assess the PK of ruxolitinib .

  2. Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6 [ Time Frame: Day 1, Day 10, and Day 29 ]
    Venous blood samples will be collected to assess the PK of ruxolitinib .



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric subjects aged ≥ 2 to 17 years, inclusive
  • Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.
  • Subjects with active inflammation associated with AD.
  • Subjects with an Investigator's Global Assessment (IGA) score of at least 2 at screening and baseline.
  • Subjects with body surface area (BSA) of AD involvement of 8% to 20% at screening and baseline.
  • Subjects who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
  • Subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation.
  • Written informed consent of the parent(s) or legal guardian and a verbal or written assent from the subject when possible.

Exclusion Criteria:

  • Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline.
  • Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream) within 2 weeks of baseline.
  • Concurrent conditions and history of other diseases:

    • Presence of AD lesions only on the hands or feet without a history of involvement of other classical areas of involvement such as the face or the flexural folds.
    • Other types of eczema.
    • 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 subject safety.
    • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome) or have 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 4 weeks before the baseline visit.
    • Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit.
    • Chronic asthma requiring more than 880 μg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • Subjects with cytopenias at screening per protocol-defined criteria.
  • Use of the following medications:

    • Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
    • Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
    • Subjects who have previously received JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
    • 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.
    • Use of any prohibited medications within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
  • Parent or legal guardian who, in the opinion of the investigator, is unable or unlikely to comply with the administration schedule and study evaluations or are unable or unwilling to apply the study drug.

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): NCT03257644


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Locations
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United States, Arizona
Desert Sky Dermatology Recruiting
Gilbert, Arizona, United States, 85295
United States, Arkansas
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
United States, Florida
Acevedo Clinical Research Associates Recruiting
Miami, Florida, United States, 33142
Olympian Clinical Research Recruiting
Tampa, Florida, United States, 33609
United States, Idaho
Advanced Clinical Research at Treasure Valley Dermatology and Skin Cancer Center Recruiting
Boise, Idaho, United States, 83713
United States, Illinois
Northwestern University Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
The Dermatology Center of Indiana - Plainfield Recruiting
Plainfield, Indiana, United States, 46168
United States, North Carolina
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
United States, Texas
Texas Dermatology and Laser Specialist Clinical Research Recruiting
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Michael Kuligowski, MD, PhD, MBA Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03257644     History of Changes
Other Study ID Numbers: INCB 18424-102
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 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
Janus kinase (JAK) inhibitor
pediatric
inflammation
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases