Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

NCT05456529 | Completed Phase 3 Results FDA Drug

• 1 other identifier: INCB 18424-315
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 38

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).

Conditions

Atopic Dermatitis (AD)

Keywords

atopic dermatitis (AD); adolescents; pruritus; eczema; topical therapy; JAK inhibitor

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.

  up to 462 days

• Number of Participants With ≥Grade 3 TEAEs

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

  up to 462 days

Secondary Outcomes (29)

• CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing

  up to Week 8

• CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing

  up to Week 8

• CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing

  up to Week 8

• CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing

  up to Week 8

• CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing

  up to Week 8

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

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

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

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

Also known as: INCB18424 cream

Ruxolitinib

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Hemoglobin \< 100 g/L (\< 10 g/dL)
• 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:
• half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (38)

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Peninsula Research Associates Pra

Rolling Hills Estates, California, 90274, United States

Location

Advanced Rx Clinical Research Group, Inc

Westminster, California, 92683-4567, United States

Location

Encore Medical Research, Llc Hollywood

Hollywood, Florida, 33021, United States

Location

Solutions Through Advanced Research, Inc

Jacksonville, Florida, 32256, United States

Location

Acevedo Clinical Research

Miami, Florida, 33142-2946, United States

Location

Skin Research of South Florida, Llc

Miami, Florida, 33173, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33173, United States

Location

Forward Clinical Trials

Tampa, Florida, 33613, United States

Location

Iact Health

Columbus, Georgia, 31904, United States

Location

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, 61761-6280, United States

Location

Northshore University Health System

Skokie, Illinois, 60077, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, 68144, United States

Location

Empire Dermatology

East Syracuse, New York, 13057, United States

Location

Sadick Dermatology Sadick Research Group

New York, New York, 10075, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Aventiv Research Inc-Dublin

Dublin, Ohio, 43016, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Jordan Valley Medical Center

West Jordan, Utah, 84088-8873, United States

Location

Dermatology Research Institute

Calgary, Alberta, T1Y 0B4, Canada

Location

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Lmc Manna Research (London)

London, Ontario, N6A 2C2, Canada

Location

Manna Research Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Xlr8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, 42-200, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, 20-081, Poland

Location

Dermedic Dr. Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Klinika Ambroziak

Warsaw, 02-953, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus; Eczema

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; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Brett Angel, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: September 1, 2022
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (26); CA (6); PL (6)