A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

NCT ID: NCT06238817

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-26
• Study Completion Date: 2025-10-17

Brief Summary

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VC Period: Ruxolitinib 1.5% Cream BID

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group Type: EXPERIMENTAL

Ruxolitinib Cream

Intervention Type: DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

VC Period: Vehicle Cream BID

Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID

Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group Type: EXPERIMENTAL

Ruxolitinib Cream

Intervention Type: DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

VC Extension Period/Escape Arm: Vehicle Cream BID

Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group Type: EXPERIMENTAL

Ruxolitinib Cream

Intervention Type: DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Interventions

Ruxolitinib Cream

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Intervention Type: DRUG

Vehicle Cream

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Intervention Type: DRUG

Other Intervention Names

INCB018424 Phosphate Cream

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥ 18 years at screening (Note: Legal adult age for Korea is ≥ 19 years).
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
• AD duration of at least 2 years.
• IGA score of 3 at screening and Day 1.
• EASI score > 7 at screening and Day 1.
• Itch NRS score ≥ 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days.
• %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1.
• DLQI score > 10 at screening and Day 1.
• Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs.
• Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol.
• Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.

Exclusion Criteria

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
• 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 Day 1.
• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1.
• 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:

• AST or ALT ≥ 2 × ULN.
• Alkaline phosphatase > 1.5 × ULN.
• Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) with the exception of Gilbert's disease.
• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
• Positive serology test results for HIV antibody.
• 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 Day 1:

• 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
• 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus).
• 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors.
• 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).

Note: COVID-19 vaccination is allowed.

• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as 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.

• History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition.
• 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 that 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.
• In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

First Oc Dermatology

Fountain Valley, California, United States

Center For Dermatology Cosmetic and Laser Surgery

Fremont, California, United States

Medderm Associates, Inc

San Diego, California, United States

Encore Medical Research, Llc Hollywood

Hollywood, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Lane Dermatology and Dermatologic Surgery

Columbus, Georgia, United States

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Northshore University Healthsystem

Skokie, Illinois, United States

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, United States

Revival Research Institute, Llc Troy

Troy, Michigan, United States

Best Skin Research

Camp Hill, Pennsylvania, United States

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Center For Clinical Studies Webster

Houston, Texas, United States

Texas Dermatology Research Center

Plano, Texas, United States

Rainey and Finklea Dermatology

San Antonio, Texas, United States

North Sound Dermatology

Mill Creek, Washington, United States

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia

Clinical Trials Sa

Campbelltown, South Australia, Australia

Skin Health Institute Inc.

Carlton, Victoria, Australia

Paratus Clinical Research, Woden

Phillip, , Australia

Ulb Hospital Erasme

Brussels, , Belgium

Cliniques Universitaires Ucl Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, , Belgium

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, , Belgium

Grand Hopital de Charleroi

Gilly, , Belgium

Dermatologie Handelskaai

Kortrijk, , Belgium

Mhat Dr. Tota Venkova Ad

Gabrovo, , Bulgaria

Medical Center Medconsult Pleven Ood

Pleven, , Bulgaria

Ambulatory For Specialized Medical Help - Skin and Venereal Diseases

Sofia, , Bulgaria

Dcc 'Alexandrovska', Eood

Sofia, , Bulgaria

Medical Center Hera Eood

Sofia, , Bulgaria

Diagnostic Consultative Center Xxviii

Sofia, , Bulgaria

Medical Center Assoc. Prof. Vasilev

Sofia, , Bulgaria

Dermatology Research Institute Inc.

Calgary, Alberta, Canada

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, Canada

Wiseman Dermatology Research Inc

Winnipeg, Manitoba, Canada

Dr. Irina Turchin Pc Inc.

Fredericton, New Brunswick, Canada

Lynderm Research Inc

Markham, Ontario, Canada

Skin Centre For Dermatology

Peterborough, Ontario, Canada

Centre de Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, Canada

Skincare Studio Dermatology Centre

St. John's, , Canada

Ghicl - Hôpital Saint-Vincent de Paul

Lille, , France

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

Nantes, , France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Chu de Rouen - Hospital Charles Nicolle

Rouen, , France

University Hospital of Saint Etienne

Saint-Etienne, , France

Universitaetsklinikum Augsburg Sued

Augsburg, , Germany

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, , Germany

Praxis Fuer Haut- Und Geschlechtskrankheiten Dr. Med. Thomas Wildfeuer Und Partner

Berlin, , Germany

Universitatsklinikum Munster

Münster, , Germany

Dermatologie Potsdam Mvz Gmbh

Potsdam, , Germany

Clinexpert Kft.

Budapest, , Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, , Hungary

Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, , Italy

Azienda Ospedaliera Universitaria Federico Ii

Napoli, , Italy

Universita Degli Studi Della Campania Luigi Vanvitelli

Napoli, , Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, , Italy

Irccs Istituto Clinico Humanitas

Rozzano, , Italy

Bravis Ziekenhuis

Bergen op Zoom, , Netherlands

Amphia Ziekenhuis, Molengracht

Breda, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

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

Gdansk, , Poland

Centrum Medyczne Pratia Katowice

Katowice, , Poland

Centrum Medyczne All-Med

Krakow, , Poland

Pratia McM Krakow

Krakow, , Poland

Santa Sp. Z O.O. Santa Familia Ptg Lodz

Lodz, , Poland

Etg Lublin

Lublin, , Poland

Solumed Centrum Medyczne

Poznan, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Centrum Medyczne Evimed

Warsaw, , Poland

Klinika Ambroziak Dermatologia

Warsaw, , Poland

Dermmedica Sp. Z O.O.

Wroclaw, , Poland

Ceim Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Hospital Infanta Leonor

Madrid, , Spain

Hospital Universitario de La Paz

Madrid, , Spain

Hospital de Manises

Manises, , Spain

Hospital Marina Baixa

Villajoyosa, , Spain

Universitatsspital Basel

Basel, , Switzerland

Inselspital Universitatsklinik Fur Medizinische Onkologie

Bern, , Switzerland

Dermatology & Skin Care Clinic

Buochs, , Switzerland

Universitatsspital Zurich

Zurich, , Switzerland

West Middlesex University Hospital

Isleworth, , United Kingdom

Guys Hospital

London, , United Kingdom

Northampton General Hospital

Northampton, , United Kingdom

University Hospital Plymouth

Plymouth, , United Kingdom

Walsall Manor Hospital

Walsall, , United Kingdom

Countries

United States; Australia; Belgium; Bulgaria; Canada; France; Germany; Hungary; Italy; Netherlands; Poland; Spain; Switzerland; United Kingdom

Related Links

https://www.incyteclinicaltrials.com/study/?id=INCB18424-326&SearchTerm=INCB18424-326&Latitude=&Longitude=&LocationName=&conditions=&Status=&phases=&AgeRanges=&gender=&StudyTypes=&AttachmentTypes=&MileRadius=100&PageIndex=0&PageSize=10&SortField=&SortOrder=&hasResults=

A study to evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Other Identifiers

2023-505433-27-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB18424-326

Identifier Type: -

Identifier Source: org_study_id