A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
1 other identifier
interventional
70
1 country
23
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2017
Typical duration for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedStudy Start
First participant enrolled
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedNovember 10, 2020
November 1, 2020
3 years
August 18, 2017
November 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants with treatment-emergent adverse events (TEAEs)
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.
Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
Secondary Outcomes (2)
Plasma concentrations of ruxolitinib for Cohorts 1 and 2
Day 1, Day 15, and Day 29
Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
Day 1, Day 10, and Day 29
Study Arms (6)
Cohort 1
EXPERIMENTALRuxolitinib phosphate cream 0.5%.
Cohort 2
EXPERIMENTALRuxolitinib phosphate cream 1.5%.
Cohort 3
EXPERIMENTALRuxolitinib phosphate cream 0.75%.
Cohort 4
EXPERIMENTALRuxolitinib phosphate cream 1.5%.
Cohort 5
EXPERIMENTALRuxolitinib phosphate cream 0.75%.
Cohort 6
EXPERIMENTALRuxolitinib phosphate cream 1.5%.
Interventions
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cahaba Dermatology
Hoover, Alabama, 35244, United States
Desert Sky Dermatology
Gilbert, Arizona, 85295, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Orange County Research Center
Anaheim, California, 92801, United States
Children'S Hospital Los Angeles Specialt
Los Angeles, California, 90027, United States
Rady Children'S Hospital - San Diego
San Diego, California, 92123, United States
National Jewish Health
Denver, Colorado, 80206, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Acevedo Clinical Research
Miami, Florida, 33142, United States
Floridian Research Institute Llc
Miami, Florida, 33145, United States
Rm Medical Research Inc
Miami, Florida, 33174, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Iact Health
Columbus, Georgia, 31904, United States
Advanced Clinical Research
Boise, Idaho, 83713, United States
Northwestern University
Chicago, Illinois, 60611, United States
The Indiana Clincal Trials Center
Plainfield, Indiana, 46168, United States
David Fivenson, Md, Pllc
Ann Arbor, Michigan, 48103, United States
Wake Research Associates Llc
Raleigh, North Carolina, 27612, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Cyn3Rgy Research - Clinedge - Ppds
Gresham, Oregon, 97030, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Related Publications (1)
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.
PMID: 36586583DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Kuligowski, MD, PhD, MBA
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 22, 2017
Study Start
September 21, 2017
Primary Completion
October 7, 2020
Study Completion
October 7, 2020
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share