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

Sponsor

Incyte Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03257644

Collaborator

(none)

Enrollment

Locations

Arms

36.5

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Ruxolitinib phosphate cream	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 21, 2017

Actual Primary Completion Date :

Oct 7, 2020

Actual Study Completion Date :

Oct 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Ruxolitinib phosphate cream 0.5%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424
Experimental: Cohort 2 Ruxolitinib phosphate cream 1.5%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424
Experimental: Cohort 3 Ruxolitinib phosphate cream 0.75%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424
Experimental: Cohort 4 Ruxolitinib phosphate cream 1.5%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424
Experimental: Cohort 5 Ruxolitinib phosphate cream 0.75%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424
Experimental: Cohort 6 Ruxolitinib phosphate cream 1.5%.	Drug: Ruxolitinib phosphate cream Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment. Other Names: INCB018424

Outcome Measures

Primary Outcome Measures

Participants with treatment-emergent adverse events (TEAEs) [Screening through 30-37 days after end of treatment, up to approximately 12 weeks.]
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.

Secondary Outcome Measures

Plasma concentrations of ruxolitinib for Cohorts 1 and 2 [Day 1, Day 15, and Day 29]
Venous blood samples will be collected to assess the PK of ruxolitinib .
Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6 [Day 1, Day 10, and Day 29]
Venous blood samples will be collected to assess the PK of ruxolitinib .

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cahaba Dermatology	Hoover	Alabama	United States	35244
2	Desert Sky Dermatology	Gilbert	Arizona	United States	85295
3	Applied Research Center of Arkansas	Little Rock	Arkansas	United States	72212
4	Orange County Research Center	Anaheim	California	United States	92801
5	Children'S Hospital Los Angeles Specialt	Los Angeles	California	United States	90027
6	Rady Children'S Hospital - San Diego	San Diego	California	United States	92123
7	National Jewish Health	Denver	Colorado	United States	80206
8	Olympian Clinical Research	Largo	Florida	United States	33770
9	Acevedo Clinical Research	Miami	Florida	United States	33142
10	Floridian Research Institute Llc	Miami	Florida	United States	33145
11	Rm Medical Research Inc	Miami	Florida	United States	33174
12	Olympian Clinical Research	Tampa	Florida	United States	33609
13	Iact Health	Columbus	Georgia	United States	31904
14	Advanced Clinical Research	Boise	Idaho	United States	83713
15	Northwestern University	Chicago	Illinois	United States	60611
16	The Indiana Clincal Trials Center	Plainfield	Indiana	United States	46168
17	David Fivenson, Md, Pllc	Ann Arbor	Michigan	United States	48103
18	Wake Research Associates Llc	Raleigh	North Carolina	United States	27612
19	Ohio Pediatric Research Association	Dayton	Ohio	United States	45414
20	Cyn3Rgy Research - Clinedge - Ppds	Gresham	Oregon	United States	97030
21	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
22	Progressive Clinical Research	San Antonio	Texas	United States	78213
23	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218