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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920852
• Other study ID #: INCB 18424-103
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: February 2020
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib 1.5% cream applied twice daily.

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montréal	Quebec
United States	Orange County Research Center	Anaheim	California
United States	Oakland Hills Dermatology PC	Auburn Hills	Michigan
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	Encino Research Center	Encino	California
United States	Clinical Research Institute of Southern Oregon - Crisor	Medford	Oregon
United States	RM Medical Research, INC.	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	Pure Skin Dermatology Aesthetics at Accel Research	Orlando	Florida
United States	Clinical Research Partners LLC	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment-emergent adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug.	Up to 127 days
Secondary	Plasma concentration of ruxolitinib		Up to 127 days
Secondary	Cmax of ruxolitinib	Maximum measured plasma concentration.	Up to 127 days
Secondary	Tmax of ruxolitinib	Time to achieve the observed maximum plasma concentration.	Up to 127 days
Secondary	AUC0-12 of ruxolitinib	Area under the concentration-time curve from 0 to 12 hours.	Up to 127 days