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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Ruxolitinib cream

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.
• United States
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Center
    • Encino, California, United States, 91436
      • Encino Research Center
  • Florida
    • Miami, Florida, United States, 33174
      • RM Medical Research, Inc.
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Orlando, Florida, United States, 32819
      • Pure Skin Dermatology Aesthetics at Accel Research
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology Pc
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute Of Southern Oregon - Crisor
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Michael E. Kuligowski, MD, Incyte Corporation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): December 26, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Atopic dermatitis; ruxolitinib cream; maximum use
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: INCB 18424-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No