Clinical trial NCT03257644: A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
Official title: An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Janus kinase (JAK) inhibitor
pediatric
inflammation
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility 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.

Primary outcomes:
measure: Participants with treatment-emergent adverse events (TEAEs)
timeFrame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
Secondary outcomes:
measure: Plasma concentrations of ruxolitinib for Cohorts 1 and 2
timeFrame: Day 1, Day 15, and Day 29
measure: Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
timeFrame: Day 1, Day 10, and Day 29
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Gilbert
country: United States
facility: Desert Sky Dermatology
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Center
state: California
city: Los Angeles
country: United States
facility: Children'S Hospital Los Angeles Specialt
state: California
city: San Diego
country: United States
facility: Rady Children'S Hospital - San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute Llc
state: Florida
city: Miami
country: United States
facility: Rm Medical Research Inc
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Columbus
country: United States
facility: Iact Health
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clincal Trials Center
state: Indiana
city: Ann Arbor
country: United States
facility: David Fivenson, Md, Pllc
state: Michigan
city: Raleigh
country: United States
facility: Wake Research Associates Llc
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Gresham
country: United States
facility: Cyn3Rgy Research - Clinedge - Ppds
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Michael Kuligowski, MD, PhD, MBA
role: STUDY_DIRECTOR
References: