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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03257644
Other study ID # INCB 18424-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 21, 2017
Est. completion date October 7, 2020

Study information

Verified date November 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 7, 2020
Est. primary completion date October 7, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.

Locations

Country Name City State
United States Orange County Research Center Anaheim California
United States David Fivenson, Md, Pllc Ann Arbor Michigan
United States Advanced Clinical Research Boise Idaho
United States Northwestern University Chicago Illinois
United States Iact Health Columbus Georgia
United States Ohio Pediatric Research Association Dayton Ohio
United States National Jewish Health Denver Colorado
United States Desert Sky Dermatology Gilbert Arizona
United States Cyn3Rgy Research - Clinedge - Ppds Gresham Oregon
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Cahaba Dermatology Hoover Alabama
United States Olympian Clinical Research Largo Florida
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Children'S Hospital Los Angeles Specialt Los Angeles California
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 The Indiana Clincal Trials Center Plainfield Indiana
United States Wake Research Associates Llc Raleigh North Carolina
United States Progressive Clinical Research San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Rady Children'S Hospital - San Diego San Diego California
United States Olympian Clinical Research Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Plasma concentrations of ruxolitinib for Cohorts 1 and 2 Venous blood samples will be collected to assess the PK of ruxolitinib . Day 1, Day 15, and Day 29
Secondary Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6 Venous blood samples will be collected to assess the PK of ruxolitinib . Day 1, Day 10, and Day 29
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