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

NCT06238817 | Completed Phase 3 FDA Drug

• 2 other identifiers: INCB18424-3262023-505433-27-00
• Study Type: interventional
• Target: 241
• Locations: 14 countries
• Sites: 94

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

Keywords

Atopic dermatitis; pruritus; eczema; topical therapy; JAK inhibitor

Outcome Measures

Primary Outcomes (2)

• VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)

  Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.

  Baseline to Week 8

• VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)

  Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.

  Baseline to Week 8

Secondary Outcomes (36)

• VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

  Baseline to Week 8

• VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

  Baseline to Day 7

• VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

  Baseline to Day 3

• VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

  Baseline to Day 2

• VC Period: Number of Treatment Emergent Adverse Events (TEAEs)

  Up to Week 24, followed by 30 days follow-up

Study Arms (5)

VC Period: Ruxolitinib 1.5% Cream BID

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

VC Period: Vehicle Cream BID

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

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

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

VC Extension Period/Escape Arm: Vehicle Cream BID

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

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

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

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

Also known as: INCB018424 Phosphate Cream

VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID; VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm; VC Period: Ruxolitinib 1.5% Cream BID

Vehicle Cream DRUG

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

VC Extension Period/Escape Arm: Vehicle Cream BID; VC Period: Vehicle Cream BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (94)

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

Medderm Associates, Inc

San Diego, California, 92103, United States

Location

Encore Medical Research, Llc Hollywood

Hollywood, Florida, 33021, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Lane Dermatology and Dermatologic Surgery

Columbus, Georgia, 31904, United States

Location

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, 30060, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

Location

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute, Llc Troy

Troy, Michigan, 48084, United States

Location

Best Skin Research

Camp Hill, Pennsylvania, 17011, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Center For Clinical Studies Webster

Houston, Texas, 77004, United States

Location

Texas Dermatology Research Center

Plano, Texas, 75025, United States

Location

Rainey and Finklea Dermatology

San Antonio, Texas, 78213, United States

Location

North Sound Dermatology

Mill Creek, Washington, 98012, United States

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 02217, Australia

Location

Australian Clinical Research Network

Maroubra, New South Wales, 02035, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 04102, Australia

Location

Clinical Trials Sa

Campbelltown, South Australia, 05074, Australia

Location

Skin Health Institute Inc.

Carlton, Victoria, 03053, Australia

Location

Paratus Clinical Research, Woden

Phillip, 02606, Australia

Location

Ulb Hospital Erasme

Brussels, 01070, Belgium

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650, Belgium

Location

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 09000, Belgium

Location

Grand Hopital de Charleroi

Gilly, 06060, Belgium

Location

Dermatologie Handelskaai

Kortrijk, 08500, Belgium

Location

Mhat Dr. Tota Venkova Ad

Gabrovo, 05300, Bulgaria

Location

Medical Center Medconsult Pleven Ood

Pleven, 05800, Bulgaria

Location

Ambulatory For Specialized Medical Help - Skin and Venereal Diseases

Sofia, 01407, Bulgaria

Location

Dcc 'Alexandrovska', Eood

Sofia, 01431, Bulgaria

Location

Medical Center Hera Eood

Sofia, 01510, Bulgaria

Location

Diagnostic Consultative Center Xxviii

Sofia, 01592, Bulgaria

Location

Medical Center Assoc. Prof. Vasilev

Sofia, 01618, Bulgaria

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Wiseman Dermatology Research Inc

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr. Irina Turchin Pc Inc.

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Centre de Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Skincare Studio Dermatology Centre

St. John's, A1E 1V4, Canada

Location

Ghicl - Hôpital Saint-Vincent de Paul

Lille, 59020, France

Location

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

Nantes, 44093, France

Location

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Chu de Rouen - Hospital Charles Nicolle

Rouen, 76000, France

Location

University Hospital of Saint Etienne

Saint-Etienne, 42055, France

Location

Universitaetsklinikum Augsburg Sued

Augsburg, 86179, Germany

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, 48455, Germany

Location

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

Berlin, 13055, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Dermatologie Potsdam Mvz Gmbh

Potsdam, 14467, Germany

Location

Clinexpert Kft.

Budapest, 01033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 01036, Hungary

Location

Semmelweis Egyetem

Budapest, 01085, Hungary

Location

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, 04032, Hungary

Location

Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 06720, Hungary

Location

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

Location

Azienda Ospedaliera Universitaria Federico Ii

Napoli, 80131, Italy

Location

Universita Degli Studi Della Campania Luigi Vanvitelli

Napoli, 80131, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, 00168, Italy

Location

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Bravis Ziekenhuis

Bergen op Zoom, 4624 VT, Netherlands

Location

Amphia Ziekenhuis, Molengracht

Breda, 04818, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713GZ, Netherlands

Location

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

Gdansk, 80-546, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Centrum Medyczne All-Med

Krakow, 30-033, Poland

Location

Pratia McM Krakow

Krakow, 30-727, Poland

Location

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

Lodz, 90-302, Poland

Location

Etg Lublin

Lublin, 20-412, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71- 500, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-503, Poland

Location

Ceim Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Hospital Marina Baixa

Villajoyosa, 03570, Spain

Location

Universitatsspital Basel

Basel, CH-4055, Switzerland

Location

Inselspital Universitatsklinik Fur Medizinische Onkologie

Bern, 03010, Switzerland

Location

Dermatology & Skin Care Clinic

Buochs, 06374, Switzerland

Location

Universitatsspital Zurich

Zurich, 08091, Switzerland

Location

West Middlesex University Hospital

Isleworth, TW7 6AF, United Kingdom

Location

Guys Hospital

London, SE1 9RT, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

University Hospital Plymouth

Plymouth, PL6 8DH, United Kingdom

Location

Walsall Manor Hospital

Walsall, WS2 9PS, United Kingdom

Location

Related Links

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

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

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: January 25, 2024
• First Posted: February 2, 2024
• Study Start: April 26, 2024
• Primary Completion: May 21, 2025
• Study Completion: October 17, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

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

CA (8); US (18); HU (5); NL (3); PL (11); ES (6); CH (4); AU (6); BU (7); FR (5); BE (6); IT (5); DE (5); GB (5)