A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
TRuE-AD5
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
2 other identifiers
interventional
240
11 countries
96
Brief Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2025
Typical duration for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 18, 2028
December 18, 2025
December 1, 2025
1.1 years
February 4, 2025
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75)
Defined as achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI) score from baseline.
VC Week 8
Secondary Outcomes (16)
VC Period: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS)
VC Week 8
VC Period: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
VC Week 8
DC Period: Time to first disease exacerbation, defined as Investigator's Global Assessment score of ≥ 2 (DE) in the DC period
Up to 44 Weeks
Number of Treatment Emergent Adverse Events (TEAEs)
From Baseline up to 70 weeks
Binary response status of Eczema Area and Severity Index 75 (EASI75) at each postbaseline visit except Week 8
Up to 44 weeks
- +11 more secondary outcomes
Study Arms (6)
Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)
EXPERIMENTALStudy drug will be administered twice daily.
VC Period: Vehicle Cream
PLACEBO COMPARATORMatching vehicle cream will be administered twice daily.
Disease Control (DC) Period: Ruxolitinib (1.5% Cream)
EXPERIMENTALStudy drug will be administered twice weekly.
DC Period: Vehicle Cream
PLACEBO COMPARATORMatching vehicle cream will be administered twice weekly.
DC Period: Open Label - Ruxolitinib (1.5% Cream)
EXPERIMENTALStudy drug will be administered twice daily to treat Disease Exacerbations.
Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)
EXPERIMENTALStudy drug will be administered twice daily.
Interventions
The study cream will be applied topically as defined in the protocol for each period.
Matching vehicle cream will be applied topically as defined in the protocol for each period.
Eligibility Criteria
You may qualify if:
- Aged 6 to \< 18 years at the VC Day 1 visit.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
- AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to \< 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD).
- EASI score \> 7 at the screening and VC Day 1 visits.
- IGA score of 3 at the screening and VC Day 1 visits.
- Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits.
- Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as the average of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days.
- Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows:
- Inadequate response:
- For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and
- For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment according to the product prescribing information.
- Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs.
- Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued.
- Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance.
- Contraindication: As defined in the product prescribing information.
- +4 more criteria
You may not qualify if:
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit.
- Concurrent conditions and history of other diseases as follows:
- Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the VC Day 1 visit.
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit.
- Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
- Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
- Current or history of hepatitis B or C virus infection.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Any of the following clinical laboratory test results at screening:
- Hemoglobin \< 10 g/dL.
- Liver function tests:
- Absolute neutrophil count \< 1000/μL.
- Platelet count \< 100,000/μL.
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Saguaro Dermatology
Phoenix, Arizona, 85008, United States
National Jewish Health
Denver, Colorado, 80206, United States
Encore Medical Research, Llc Hollywood
Hollywood, Florida, 33024, United States
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia, 31904, United States
Cleaver Medical Group
Cumming, Georgia, 30040, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, 61761, United States
Endeavor Health Medical Group
Skokie, Illinois, 60077, United States
Raven Clinical Research
Marriottsville, Maryland, 21104, United States
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, 48326, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Red River Research Partners
Bolivar, Missouri, 65613, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Texas Physicians - Bellaire Station
Bellaire, Texas, 77401, United States
Frontier Dermatology
Mill Creek, Washington, 98012, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200, Belgium
Az Sint-Lucas
Ghent, 09000, Belgium
Universitair Ziekenhuis Gent
Ghent, 09000, Belgium
Grand Hôpital de Charleroi-Les Viviers
Gilly, 06060, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 04000, Belgium
Dermatologie Maldegem
Maldegem, 09990, Belgium
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Dermatology Research Institute Inc.
Calgary, Alberta, T2J 7E1, Canada
Laster Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9, Canada
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)
Vancouver, British Columbia, V6H 3V4, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Leader Research
Hamilton, Ontario, L8L 3C3, Canada
Facet Dermatology
Toronto, Ontario, M4E 1R7, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Centre de Recherche Saint-Louis
Montreal, Quebec, H1Y3LI, Canada
Chu Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Chu de Quebec Universite Laval
Québec, Quebec, G1V 4G2, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1, Canada
Skincare Studio Dermatology Centre
St. John's, A1E 1V4, Canada
Bordeaux Chu Hopital Saint - Andre
Bordeaux, 33000, France
Polyclinique Reims-Bezannes
Reims, 51100, France
Hopitaux Drome Nord
Romans-sur-Isère, 26102, France
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, 48455, Germany
Universitatsklinikum Bonn Aoer
Bonn, 53127, Germany
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, 09117, Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, 01307, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitatsmedizin Goettingen
Göttingen, 37075, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Clinexpert Kft.
Budapest, 01033, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 01036, Hungary
Geomedical Orvosi Kft.
Budapest, 01066, Hungary
Semmelweis Egyetem
Budapest, 01083, Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, 04032, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, 06000, Hungary
Pecsi Tudomanyegyetem
Pécs, 07632, Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 06720, Hungary
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, 95123, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Federico Ii
Naples, 80131, Italy
Azienda Ospedale Universita Di Padova
Padua, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, 00168, Italy
Umc Utrecht
Utrecht, 3584 CX, Netherlands
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, 80-546, Poland
Gyncentrum Sp. Z O.O.
Katowice, 40-600, Poland
Grazyna Pulka Centrum Medyczne All Med Spolka Komandytowa
Krakow, 30-033, Poland
Diamond Clinic Sp. Z O.O.
Krakow, 31-559, Poland
Dermoklinika
Lodz, 90-436, Poland
Clinical Best Solutions Sp. Z O.O. Sp. K.
Lublin, 20-011, Poland
Dermodent Centrum Medyczne Czajkowscy S.C.
Osielsko, 86-031, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71- 500, Poland
Mics Centrum Medyczne Toruń
Torun, 87-100, Poland
Mics Centrum Medyczne Warszawa Chlodna
Warsaw, 00-872, Poland
High-Med Przychodnia Specjalistycza
Warsaw, 01-817, Poland
Centrum Medyczne Evimed
Warsaw, 02-625, Poland
Etg Warszawa
Warsaw, 02-677, Poland
Dermmedica Sp. Z O.O.
Wroclaw, 51-503, Poland
Hospital General Unviersitario de Alicante
Alicante, 03010, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, 08950, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, 28222, Spain
Hospital de Manis
Manises, 46940, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
West Glasgow Ambulatory Care Hospital
Glasgow, G3 8SJ, United Kingdom
St John'S Institute of Dermatology
London, SE1 7EH, United Kingdom
The Adam Practice
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
University of Nottingham Health Service
Nottingham, NG7 2QW, United Kingdom
Sheffield Childrens Hospital
Sheffield, S10 2TH, United Kingdom
Walsall Manor Hospital
Walsall, WS2 9PS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 18, 2025
Study Start
June 17, 2025
Primary Completion (Estimated)
July 13, 2026
Study Completion (Estimated)
May 18, 2028
Last Updated
December 18, 2025
Record last verified: 2025-12
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.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.