A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

Last updated: March 10, 2025
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Dermatitis, Atopic

Hives (Urticaria)

Treatment

Vehicle Cream

Ruxolitinib

Clinical Study ID

NCT04921969
INCB 18424-305
  • Ages 2-11
  • All Genders

Study Summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin andRajka criteria.

  • Participants with AD duration of at least 3 months (participant/parent/guardian mayverbally report signs and symptoms of AD with onset at least 3 months prior).

  • Participants with IGA score of 2 to 3 at the screening and baseline visits.

  • Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screeningand baseline visits.

  • For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.

  • Participants/guardians who agree to discontinue all agents used by the participantto treat AD from the screening visit through the final safety follow-up visit.

  • Participants with at least 1 target lesion that measures at least 5 cm2 at thescreening and baseline visits. The target lesion must be representative of theparticipant's disease state but not located on the hands, feet, or genitalia.

  • Willingness to avoid pregnancy or fathering a child for the duration of studyparticipation.

Exclusion

Exclusion Criteria:

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) asdetermined by the investigator over the previous 4 weeks before the baseline visit.

  • Concurrent conditions and history of other diseases as follows:

  1. Immunocompromised

  2. Chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeksbefore the baseline visit.

  3. Active acute bacterial, fungal, or viral skin infection within 1 week beforethe baseline visit.

  4. Any other concomitant skin disorder, pigmentation, or extensive scarring thatin the opinion of the investigator may interfere with the evaluation of ADlesions or compromise participant safety.

  5. Presence of AD lesions only on the hands or feet without prior history ofinvolvement of other classic areas of involvement such as the face or theflexural folds.

  6. Other types of eczema.

  7. Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalenthigh dose of other inhaled corticosteroids.

  • Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study drug and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.

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

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

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

  3. 2 weeks - immunizations with activated vaccines; sedating antihistamines unlesson a long-term stable regimen (nonsedating antihistamines are permitted). Note:Live vaccines are not recommended during the VC period.

  4. 1 week - use of topical treatments for AD (other than bland emollients, eg,Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids,calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topicalantibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodiumhypochlorite "bleach" baths are allowed as long as they do not exceed 2 bathsper week.

  • Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources ofUV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baselinevisit and/or intention to have such exposure during the study, which is thought bythe investigator to potentially impact the participant's AD.-

  • Positive serology test results at screening for HIV antibody.

  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)before the baseline visit with another investigational medication or currentenrollment in another investigational drug protocol.

  • In the opinion of the investigator, unable or unlikely to comply with theadministration schedule and study evaluations.

  • Employees of the sponsor or investigator or otherwise dependents of them.

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Vehicle Cream
Phase: 3
Study Start date:
July 19, 2021
Estimated Completion Date:
April 08, 2024

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Vida Clinical Research

    Edmonton, Alberta TGH 4J8
    Canada

    Site Not Available

  • Skinfitmd

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Leader Research

    Burlington, Ontario L7R 4H9
    Canada

    Site Not Available

  • Ontario Pediatric Allergy Research Corporation

    Burlington, Ontario L7L 6W6
    Canada

    Site Not Available

  • Leader Research

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Dermatology Ottawa Research Centre

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • Probity Medical Research Inc Pmr

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • University of Montreal

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • CHARIT� - UNIVERSIT�TSMEDIZIN BERLIN

    Berlin, 13353
    Germany

    Site Not Available

  • Charite Universitatsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Katholisches Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149
    Germany

    Site Not Available

  • Mensingderma Medic

    Hamburg, 22391
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • University Medical Center Schleswig-Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Asst Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Nuovo Ospedale San Giovanni Di Dio (Torregalli)

    Firenze, 50143
    Italy

    Site Not Available

  • Ospedale Piero Palagi

    Firenze, 50125
    Italy

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia

    Milan, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedale Maggiore

    Parma, 43126
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168
    Italy

    Site Not Available

  • Centrum Badan Klinicznych Pi-House Sp. Z O.O.

    Gdansk, 80-546
    Poland

    Site Not Available

  • Synexus Polska Sp. Z O.O. Oddzial W Gdansku

    Gdansk, 80-382
    Poland

    Site Not Available

  • Universyteckie Centrum Kliniczne Gdanskiego Uniwersytetu Medycznego Klinika Dermatologii, Wenerologi

    Gdansk, 80-214
    Poland

    Site Not Available

  • Angelius Badania Kliniczne

    Katowice, 40-611
    Poland

    Site Not Available

  • Dermoklinika Centrum Medyczne

    Lodz, 90-436
    Poland

    Site Not Available

  • Twoja Klinika

    Mikolow, 43-190
    Poland

    Site Not Available

  • Twoja Klinikal

    Mikolów, 43-190
    Poland

    Site Not Available

  • Clinical Research Group (Crg)

    Warszawa, 02-201
    Poland

    Site Not Available

  • Klinika Ambroziak

    Warszawa, 02-758
    Poland

    Site Not Available

  • Synexus Polska Sp Z O.O. Oddzial W Warszawie

    Warszawa, 01-192
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 02-507
    Poland

    Site Not Available

  • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

    Wroclaw, 50-381
    Poland

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital General Unviersitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitario Germans Trias I Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008
    Spain

    Site Not Available

  • The University of Sheffield - the Medical School - Sheffield Dermatology Research

    Sheffield, S10 2RX
    United Kingdom

    Site Not Available

  • Clinical Research Center of Alabama

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Cahaba Dermatology

    Hoover, Alabama 35244
    United States

    Site Not Available

  • Physicians Research Group Ii

    Gilbert, Arizona 85295
    United States

    Site Not Available

  • Cct Research With Center For Dermatology and Plastic Surgery

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Burke Pharmaceutical Research

    Hot Springs National Park, Arkansas 71913
    United States

    Site Not Available

  • First Oc Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Iact Health

    Los Angeles, California 90017
    United States

    Site Not Available

  • Metropolis Dermatology

    Los Angeles, California 90017
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Madera Family Medical Group

    Madera, California 93637
    United States

    Site Not Available

  • Allergy & Asthma Associates of Southern California

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Palmtree Clinical Research - Clinedge - Ppds

    Palm Springs, California 92262
    United States

    Active - Recruiting

  • Palmtree Clinical Research-Clinedge-Ppds

    Palm Springs, California 92262
    United States

    Site Not Available

  • Integrated Research of Inland, Inc

    Riverside, California 92506
    United States

    Site Not Available

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California 90404
    United States

    Site Not Available

  • Phdermatology

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Life Clinical Trials Margate

    Margate, Florida 33063
    United States

    Site Not Available

  • Acevedo Clinical Research

    Miami, Florida 33142
    United States

    Site Not Available

  • Ciocca Dermatology Pa

    Miami, Florida 33173
    United States

    Site Not Available

  • Entrust Clinical Research

    Miami, Florida 33156
    United States

    Site Not Available

  • Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc

    Miami, Florida 33146
    United States

    Site Not Available

  • The Childrens Skin Center Csc Miami

    Miami, Florida 33155
    United States

    Site Not Available

  • Forcare Clinical Research

    Tampa, Florida 33624
    United States

    Site Not Available

  • Forcare Clinical Research Fcr Forward Clinical Trials, Inc

    Tampa, Florida 33624
    United States

    Active - Recruiting

  • Aeroallergy Research Lab of Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Northwestern Memorial Hospital - Arkes Pavilion

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital-Arkes Pavilion

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Sneeze Wheeze and Itch Associates Llc

    Normal, Illinois 61761
    United States

    Site Not Available

  • Northshore Medical Group Dermatology Skokie

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Dermatology Specialists Research Indiana

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group Llc

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Kansas City Dermatology P.A.

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Office of Michael W. Simon, Md

    Nicholasville, Kentucky 40356
    United States

    Site Not Available

  • Delricht Clinical Research - Clinedge - Ppds Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Delricht Clinical Research-Clinedge-Ppds Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Meridian Clinical Research

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Delricht Research - Touro Medical Center

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Delricht Research-Touro Medical Center

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Lawrence J. Green, Md. Llc

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Medical Center-New Center One

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Michigan Dermatology Institute

    Waterford, Michigan 48328
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Skin Specialists Pc the Advanced Skin Research Center

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Dr Bobby Buka, Md Greenwich Village

    New York, New York 10012
    United States

    Site Not Available

  • New York University Langone Medical Center - Fink Children'S Ambulatory Care Center

    New York, New York 10016
    United States

    Active - Recruiting

  • New York University Langone Medical Center-Fink Children'S Ambulatory Care Center

    New York, New York 10016
    United States

    Site Not Available

  • Ohio Pediatric Research Association

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • Cyn3Rgy Research - Clinedge - Ppds

    Gresham, Oregon 97030
    United States

    Active - Recruiting

  • Cyn3Rgy Research-Clinedge-Ppds

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Velocity Clinical Research - Medford

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Velocity Clinical Research-Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Knight Cancer Institute At Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Coastal Pediatric Associates

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Texas Dermatology Alamo Heights Office

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Allergy and Asthma Care of Waco, Pa

    Waco, Texas 76712
    United States

    Site Not Available

  • Intermountain Clinical Research Icr Draper

    Draper, Utah 84020
    United States

    Site Not Available

  • Springville Dermatology

    Springville, Utah 84663
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Skindc Clinic

    Arlington, Virginia 22209
    United States

    Site Not Available

  • Pi Coor Clinical Research Llc

    Burke, Virginia 22015
    United States

    Site Not Available

  • Clinical Research Partners Llc

    Richmond, Virginia 23220
    United States

    Site Not Available

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

  • Children'S Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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