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

Atopic Dermatitis Clinical Trial

Official title:

An Open-Label, Pilot Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257644
• Other study ID #: INCB 18424-102
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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