A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis

Sponsor

Incyte Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03920852

Collaborator

(none)

Enrollment

Locations

Arm

6.9

Actual Duration (Months)

4.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label maximum use trial to evaluate ruxolitinib safety and blood levels after its topical application twice daily to affected areas (≥ 25% BSA) in adolescent and adult participants with atopic dermatitis (AD) and to determine if its systemic bioavailability results in any adverse events.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis

Actual Study Start Date :

May 30, 2019

Actual Primary Completion Date :

Dec 26, 2019

Actual Study Completion Date :

Dec 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib cream	Drug: Ruxolitinib cream Ruxolitinib 1.5% cream applied twice daily. Other Names: INCB018424 phosphate cream

Arm

Intervention/Treatment

Experimental: Ruxolitinib cream

Drug: Ruxolitinib cream

Ruxolitinib 1.5% cream applied twice daily.

Other Names:

INCB018424 phosphate cream

Outcome Measures

Primary Outcome Measures

Number of treatment-emergent adverse events [Up to 127 days]
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug.

Secondary Outcome Measures

Plasma concentration of ruxolitinib [Up to 127 days]
Cmax of ruxolitinib [Up to 127 days]
Maximum measured plasma concentration.
Tmax of ruxolitinib [Up to 127 days]
Time to achieve the observed maximum plasma concentration.
AUC0-12 of ruxolitinib [Up to 127 days]
Area under the concentration-time curve from 0 to 12 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with atopic dermatitis as defined by Hanifin and Rajka criteria.
Atopic dermatitis duration of at least 2 years.
Investigator's Global Assessment score of at least 2 at screening and baseline.
Body surface area of atopic dermatitis involvement of ≥ 25% at screening and baseline.
Agree to discontinue all agents used to treat atopic dermatitis from screening through the final follow up visit.
Willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of females of nonchildbearing potential and prepubescent adolescents.
Written informed consent of the participant or parent(s)/legal guardian and a verbal or written assent from the participant when possible.

Exclusion Criteria:

Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline.
Concurrent conditions and history of other diseases:
Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 14 days (2 weeks) before the baseline visit.
Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 7 days (1 week) before the baseline visit.
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 participant safety.
Other types of eczema.
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full study participation, pose a significant risk to the participant, or interfere with interpretation of study data.
Use of any of the following treatments within the indicated washout periods before baseline:
5 half-lives or 84 days (12 weeks), whichever is longer: biologic agents (eg, dupilumab).
28 days (4 weeks): systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
14 days (2 weeks) or 5 half-lives, whichever is longer: immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted); and potent systemic CYP3A4 inhibitors or fluconazole.
7 days (1 week): other topical treatments applied onto atopic dermatitis skin lesions (other than bland emollients), such as corticosteroids, crisaborole, calcineurin inhibitors, coal tar (shampoo), antibiotics, antibacterial cleansing body wash/soap.
Treatment with Janus kinase inhibitors (systemic or topical) within 12 weeks (3 months) from baseline.
Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (eg, sunlight or tanning booth) within 14 days (2 weeks) before baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's atopic dermatitis.
Positive serology test results at screening for HIV antibody.
Liver function test results outside the protocol-defined range.
Pregnant or lactating participants or those considering pregnancy.
History of alcoholism or drug addiction within 365 days (1 year) before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
Current treatment or treatment within 28 days (4 weeks) or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Research Center	Anaheim	California	United States	92801
2	Encino Research Center	Encino	California	United States	91436
3	San Marcus Research Clinic, Inc.	Miami Lakes	Florida	United States	33014
4	RM Medical Research, INC.	Miami	Florida	United States	33174
5	Pure Skin Dermatology Aesthetics at Accel Research	Orlando	Florida	United States	32819
6	Metro Boston Clinical Partners	Brighton	Massachusetts	United States	02135
7	Oakland Hills Dermatology PC	Auburn Hills	Michigan	United States	48326
8	Clinical Research Institute of Southern Oregon - Crisor	Medford	Oregon	United States	97504
9	Clinical Research Partners LLC	Richmond	Virginia	United States	23220
10	Innovaderm Research Inc.	Montréal	Quebec	Canada	H2K 4L5