A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
NCT ID: NCT03257644
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2017-09-21
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Ruxolitinib phosphate cream 0.5%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cohort 2
Ruxolitinib phosphate cream 1.5%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cohort 3
Ruxolitinib phosphate cream 0.75%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cohort 4
Ruxolitinib phosphate cream 1.5%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cohort 5
Ruxolitinib phosphate cream 0.75%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cohort 6
Ruxolitinib phosphate cream 1.5%.
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Interventions
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Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
17 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Kuligowski, MD, PhD, MBA
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cahaba Dermatology
Hoover, Alabama, United States
Desert Sky Dermatology
Gilbert, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Orange County Research Center
Anaheim, California, United States
Children'S Hospital Los Angeles Specialt
Los Angeles, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Olympian Clinical Research
Largo, Florida, United States
Acevedo Clinical Research
Miami, Florida, United States
Floridian Research Institute Llc
Miami, Florida, United States
Rm Medical Research Inc
Miami, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Iact Health
Columbus, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
The Indiana Clincal Trials Center
Plainfield, Indiana, United States
David Fivenson, Md, Pllc
Ann Arbor, Michigan, United States
Wake Research Associates Llc
Raleigh, North Carolina, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Cyn3Rgy Research - Clinedge - Ppds
Gresham, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Countries
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References
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Leung DYM, Paller AS, Zaenglein AL, Tom WL, Ong PY, Venturanza ME, Kuligowski ME, Li Q, Gong X, Lee MS. Safety, pharmacokinetics, and efficacy of ruxolitinib cream in children and adolescents with atopic dermatitis. Ann Allergy Asthma Immunol. 2023 Apr;130(4):500-507.e3. doi: 10.1016/j.anai.2022.12.033. Epub 2022 Dec 28.
Other Identifiers
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INCB 18424-102
Identifier Type: -
Identifier Source: org_study_id