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

NCT03920852 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 18424-103
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 10

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; ruxolitinib cream; maximum use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Plasma concentration of ruxolitinib

  Up to 127 days

• Cmax of ruxolitinib

  Up to 127 days

• Tmax of ruxolitinib

  Up to 127 days

• AUC0-12 of ruxolitinib

  Up to 127 days

Study Arms (1)

Ruxolitinib cream

EXPERIMENTAL

Drug: Ruxolitinib cream

Interventions

Ruxolitinib cream DRUG

Ruxolitinib 1.5% cream applied twice daily.

Also known as: INCB018424 phosphate cream

Ruxolitinib cream

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• half-lives or 84 days (12 weeks), whichever is longer: biologic agents (eg, dupilumab).
• days (4 weeks): systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
• 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.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (10)

Orange County Research Center

Anaheim, California, 92801, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

RM Medical Research, INC.

Miami, Florida, 33174, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Pure Skin Dermatology Aesthetics at Accel Research

Orlando, Florida, 32819, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Oakland Hills Dermatology PC

Auburn Hills, Michigan, 48326, United States

Location

Clinical Research Institute of Southern Oregon - Crisor

Medford, Oregon, 97504, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23220, United States

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Related Publications (2)

• Bissonnette R, Call RS, Raoof T, Zhu Z, Yeleswaram S, Gong X, Lee M. A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):355-364. doi: 10.1007/s40257-022-00690-3. Epub 2022 Apr 4.

  PMID: 35368221 DERIVED

• Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

  PMID: 33658996 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael E. Kuligowski, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: May 30, 2019
• Primary Completion: December 26, 2019
• Study Completion: December 26, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); CA (1)