Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

NCT ID: NCT05456529

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-05-17

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Detailed Description

The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib

Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

Group Type: EXPERIMENTAL

Ruxolitinib Cream

Intervention Type: DRUG

Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

Interventions

Ruxolitinib Cream

Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

Intervention Type: DRUG

Other Intervention Names

INCB18424 cream

Eligibility Criteria

Inclusion Criteria

• A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
• Duration of AD of at least 2 years.
• Total IGA score of 2 to 3 at the screening and baseline visits.
• Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.
• Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.
• Agree to discontinue all agents used to treat AD from screening through the final follow up visit.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

• An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• Concurrent conditions and history of other diseases
• Any current and/or history of serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example:
• Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mm Hg) unless approved by the medical monitor/sponsor.
• Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.
• Current and/or history of arterial or venous thrombosis, including DVT and PE.
• Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.
• Any of the following clinical laboratory test results at screening:

1. Hemoglobin < 100 g/L (< 10 g/dL)

2. Liver function tests:

• AST or ALT ≥ 2.5 × ULN
• Total bilirubin > 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation).

d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.

• Use of any of the following treatments within the indicated washout period before baseline:

1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).

2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).

3. 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).

Note: Live-attenuated vaccines are not recommended during the CT period. Note: COVID-19 vaccination is allowed.

4. 1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.

Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.

• Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
• Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor.
• Inability to draw blood for PK analysis from any nonlesional areas.
• Known allergy or reaction to any component of the study cream formulation.
• In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Angel, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Arlington Research Center

Arlington, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Jordan Valley Medical Center

West Jordan, Utah, United States

Dermatology Research Institute

Calgary, Alberta, Canada

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, Canada

Lmc Manna Research (London)

London, Ontario, Canada

Manna Research Toronto

Toronto, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

Xlr8 Medical Research

Windsor, Ontario, Canada

Centrum Medyczne Pratia Czestochowa

Częstochowa, , Poland

Centrum Medyczne Angelius Provita

Katowice, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, , Poland

Dermedic Dr. Zdybski

Ostrowiec Świętokrzyski, , Poland

Centrum Medyczne Evimed

Warsaw, , Poland

Klinika Ambroziak

Warsaw, , Poland

Arkansas Research Trials

North Little Rock, Arkansas, United States

First Oc Dermatology

Fountain Valley, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Peninsula Research Associates Pra

Rolling Hills Estates, California, United States

Advanced Rx Clinical Research Group, Inc

Westminster, California, United States

Encore Medical Research, Llc Hollywood

Hollywood, Florida, United States

Solutions Through Advanced Research, Inc

Jacksonville, Florida, United States

Acevedo Clinical Research

Miami, Florida, United States

Skin Research of South Florida, Llc

Miami, Florida, United States

Well Pharma Medical Research Corp.

Miami, Florida, United States

Forward Clinical Trials

Tampa, Florida, United States

Iact Health

Columbus, Georgia, United States

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, United States

Northshore University Health System

Skokie, Illinois, United States

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, United States

Empire Dermatology

East Syracuse, New York, United States

Sadick Dermatology Sadick Research Group

New York, New York, United States

Ohio Pediatric Research Association

Dayton, Ohio, United States

Aventiv Research Inc-Dublin

Dublin, Ohio, United States

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Countries

United States; Canada; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 18424-315

Identifier Type: -

Identifier Source: org_study_id