A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

NCT06832618 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB018424-3162024-518156-24-00
• Study Type: interventional
• Target: 159
• Locations: 10 countries
• Sites: 93

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Ruxolitinib

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

Study Arms (6)

Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)

EXPERIMENTAL

Study drug will be administered twice daily.

Drug: Ruxolitinib

VC Period: Vehicle Cream

PLACEBO COMPARATOR

Matching vehicle cream will be administered twice daily.

Drug: Vehicle Cream

Disease Control (DC) Period: Ruxolitinib (1.5% Cream)

EXPERIMENTAL

Study drug will be administered twice weekly.

Drug: Ruxolitinib

DC Period: Vehicle Cream

PLACEBO COMPARATOR

Matching vehicle cream will be administered twice weekly.

Drug: Vehicle Cream

DC Period: Open Label - Ruxolitinib (1.5% Cream)

EXPERIMENTAL

Study drug will be administered twice daily to treat Disease Exacerbations.

Drug: Ruxolitinib

Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)

EXPERIMENTAL

Study drug will be administered twice daily.

Drug: Ruxolitinib

Interventions

Vehicle Cream DRUG

Matching vehicle cream will be applied topically as defined in the protocol for each period.

Also known as: Placebo

DC Period: Vehicle Cream; VC Period: Vehicle Cream

Ruxolitinib DRUG

The study cream will be applied topically as defined in the protocol for each period.

Also known as: Opzelura

DC Period: Open Label - Ruxolitinib (1.5% Cream); Disease Control (DC) Period: Ruxolitinib (1.5% Cream); Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream); Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (93)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Encore Medical Research, Llc Hollywood

Hollywood, Florida, 33024, United States

Location

Lane Dermatology and Dermatologic Surgery

Columbus, Georgia, 31904, United States

Location

Cleaver Medical Group

Cumming, Georgia, 30040, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, 61761, United States

Location

Endeavor Health Medical Group

Skokie, Illinois, 60077, United States

Location

Raven Clinical Research

Marriottsville, Maryland, 21104, United States

Location

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, 48326, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Red River Research Partners

Bolivar, Missouri, 65613, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Texas Physicians - Bellaire Station

Bellaire, Texas, 77401, United States

Location

Frontier Dermatology

Mill Creek, Washington, 98012, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Az Sint-Lucas

Ghent, 09000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 09000, Belgium

Location

Grand Hôpital de Charleroi-Les Viviers

Gilly, 06060, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

Dermatologie Maldegem

Maldegem, 09990, Belgium

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

Laster Rejuvenation Clinics Edmonton D.T. Inc.

Edmonton, Alberta, T5J 3S9, Canada

Location

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)

Vancouver, British Columbia, V6H 3V4, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Leader Research

Hamilton, Ontario, L8L 3C3, Canada

Location

Facet Dermatology

Toronto, Ontario, M4E 1R7, Canada

Location

Centre de Recherche Saint-Louis

Montreal, Quebec, H1Y3LI, Canada

Location

Chu Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Chu de Quebec Universite Laval

Québec, Quebec, G1V 4G2, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Skincare Studio Dermatology Centre

St. John's, A1E 1V4, Canada

Location

Bordeaux Chu Hopital Saint - Andre

Bordeaux, 33000, France

Location

Polyclinique Reims-Bezannes

Reims, 51100, France

Location

Hopitaux Drome Nord

Romans-sur-Isère, 26102, France

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, 48455, Germany

Location

Universitatsklinikum Bonn Aoer

Bonn, 53127, Germany

Location

Drk Krankenhaus Chemnitz-Rabenstein

Chemnitz, 09117, Germany

Location

Universitaetsklinikum Carl Gustav Carus Tu Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitatsmedizin Goettingen

Göttingen, 37075, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Clinexpert Kft.

Budapest, 01033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 01036, Hungary

Location

Geomedical Orvosi Kft.

Budapest, 01066, Hungary

Location

Semmelweis Egyetem

Budapest, 01083, Hungary

Location

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, 04032, Hungary

Location

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, 06000, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 07632, Hungary

Location

Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 06720, Hungary

Location

Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

Catania, 95123, Italy

Location

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

Location

Azienda Ospedaliera Universitaria Federico Ii

Naples, 80131, Italy

Location

Azienda Ospedale Universita Di Padova

Padova, 35128, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, 00168, Italy

Location

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

Gdansk, 80-546, Poland

Location

Gyncentrum Sp. Z O.O.

Katowice, 40-600, Poland

Location

Grazyna Pulka Centrum Medyczne All Med Spolka Komandytowa

Krakow, 30-033, Poland

Location

Diamond Clinic Sp. Z O.O.

Krakow, 31-559, Poland

Location

Dermoklinika

Lodz, 90-436, Poland

Location

Clinical Best Solutions Sp. Z O.O. Sp. K.

Lublin, 20-011, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71- 500, Poland

Location

Mics Centrum Medyczne Toruń

Torun, 87-100, Poland

Location

Mics Centrum Medyczne Warszawa Chlodna

Warsaw, 00-872, Poland

Location

High-Med Przychodnia Specjalistycza

Warsaw, 01-817, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Etg Warszawa

Warsaw, 02-677, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-503, Poland

Location

Hospital General Unviersitario de Alicante

Alicante, 03010, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, 08950, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, 28222, Spain

Location

Hospital de Manis

Manises, 46940, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

West Glasgow Ambulatory Care Hospital

Glasgow, G3 8SJ, United Kingdom

Location

St John'S Institute of Dermatology

London, SE1 7EH, United Kingdom

Location

The Adam Practice

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

University of Nottingham Health Service

Nottingham, NG7 2QW, United Kingdom

Location

Sheffield Childrens Hospital

Sheffield, S10 2TH, United Kingdom

Location

Walsall Manor Hospital

Walsall, WS2 9PS, United Kingdom

Location

Related Links

• A study to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

ruxolitinib

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

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

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: July 13, 2026
• Study Completion (Estimated): May 18, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

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

HU (8); IT (5); ES (10); US (20); GB (6); PL (13); FR (3); CA (13); DE (9); BE (6)