A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (TRuE-AD4)

A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle Cream; Drug: Ruxolitinib Cream

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Australia
  • Phillip, Australia, 02606
    • Not yet recruiting
    • Paratus Clinical Research, Woden
  • New South Wales
    • Kogarah, New South Wales, Australia, 02217
      • Not yet recruiting
      • Premier Specialists Pty Ltd
    • Maroubra, New South Wales, Australia, 02035
      • Not yet recruiting
      • Australian Clinical Research Network
  • Queensland
    • Woolloongabba, Queensland, Australia, 04102
      • Not yet recruiting
      • Veracity Clinical Research
  • South Australia
    • Hectorville, South Australia, Australia, 05072
      • Not yet recruiting
      • Clinical Trials Sa
  • Victoria
    • Carlton, Victoria, Australia, 03053
      • Not yet recruiting
      • Skin Health Institute Inc.
• Belgium
  • Brussels, Belgium, 01200
    • Not yet recruiting
    • Cliniques Universitaires Ucl Saint-Luc
  • Bruxelles, Belgium, 01070
    • Not yet recruiting
    • Ulb Hospital Erasme
  • Edegem, Belgium, 02650
    • Not yet recruiting
    • Universitair Ziekenhuis Antwerpen (Uza)
  • Ghent, Belgium, 09000
    • Not yet recruiting
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 08500
    • Not yet recruiting
    • Dermatologie Handelskaai
  • Loverval, Belgium, 06280
    • Not yet recruiting
    • Grand Hopital de Charleroi
• Bulgaria
  • Gabrovo, Bulgaria, 05300
    • Not yet recruiting
    • Mhat Dr. Tota Venkova Ad
  • Haskovo, Bulgaria, 06300
    • Withdrawn
    • Dcc 'Sveti Georgi' Eood
  • Pleven, Bulgaria, 05800
    • Not yet recruiting
    • Medical Center Medconsult Pleven Ood
  • Sofia, Bulgaria, 01431
    • Not yet recruiting
    • Dcc 'Alexandrovska', Eood
  • Sofia, Bulgaria, 01510
    • Not yet recruiting
    • Medical Center Hera Eood
  • Sofia, Bulgaria, 01407
    • Not yet recruiting
    • Ambulatory For Specialized Medical Help - Skin and Venereal Diseases
  • Sofia, Bulgaria, 01592
    • Not yet recruiting
    • Dcc Xxviii
  • Sofia, Bulgaria, 01618
    • Not yet recruiting
    • Medical Center Assoc. Prof. Vasilev
• Canada
  • Quebec, Canada, G1V 4X7
    • Not yet recruiting
    • Centre de Recherche Dermatologique Du Quebec Metropolitain
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Not yet recruiting
      • Dermatology Research Institute Inc.
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Not yet recruiting
      • Dr. Chih-Ho Hong Medical Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Not yet recruiting
      • Wiseman Dermatology Research Inc
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Not yet recruiting
      • Brunswick Dermatology Center
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
      • Not yet recruiting
      • Skincare Studio Dermatology Centre
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • Not yet recruiting
      • Lynderm Research Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • Not yet recruiting
      • Skin Centre For Dermatology
• France
  • Le Mans Cedex, France, 72037
    • Withdrawn
    • Centre Hospitalier Du Mans
  • Lille Cedex, France, 59020
    • Not yet recruiting
    • Ghicl - Hôpital Saint-Vincent de Paul
  • Lille Cedex, France, 59037
    • Withdrawn
    • Chru de Lille Hopital Claude Huriez
  • Nantes, France, 44093
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Pierre Bénite Cedex, France, 69495
    • Not yet recruiting
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Rouen, France, 76000
    • Not yet recruiting
    • Chu de Rouen - Hospital Charles Nicolle
  • Saint Etienne Cedex 2, France, 42055
    • Not yet recruiting
    • University Hospital of Saint Etienne
• Germany
  • Augsburg, Germany, 86179
    • Not yet recruiting
    • Universitaetsklinikum Augsburg Sued
  • Bad Bentheim, Germany, 48455
    • Not yet recruiting
    • Fachklinik Bad Bentheim Dermatologie
  • Berlin, Germany, 13055
    • Not yet recruiting
    • Praxis Fuer Haut- Und Geschlechtskrankheiten Dr. Med. Thomas Wildfeuer Und Partner
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • Universitaetsklinikum Heidelberg
  • Muenster, Germany, 48149
    • Not yet recruiting
    • Universitatsklinikum Munster
  • Potsdam, Germany, 14467
    • Not yet recruiting
    • Dermatologie Potsdam Mvz Gmbh
• Hungary
  • Budapest, Hungary, 01085
    • Not yet recruiting
    • Semmelweis Egyetem
  • Budapest, Hungary, 01033
    • Not yet recruiting
    • Clinexpert Kft.
  • Budapest, Hungary, 01036
    • Not yet recruiting
    • Obudai Egeszsegugyi Centrum Kft.
  • Debrecen, Hungary, 04032
    • Not yet recruiting
    • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
  • Szeged, Hungary, 06720
    • Not yet recruiting
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Veszprem, Hungary, 08200
    • Not yet recruiting
    • Medmare Bt
• Italy
  • Bari, Italy, 70124
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
  • Milano, Italy, 20122
    • Not yet recruiting
    • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
  • Naples, Italy, 80131
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria 'Federico Ii'
  • Napoli, Italy, 80131
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
  • Roma, Italy, 00137
    • Not yet recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli Irccs
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Irccs Istituto Clinico Humanitas
• Korea, Republic of
  • Bucheon, Korea, Republic of, 420-767
    • Withdrawn
    • Soon Chun Hyang University Hospital (Schuh) Bucheon
  • Seoul, Korea, Republic of, 05030
    • Withdrawn
    • Konkuk University Medical Center
• Netherlands
  • Bergen Op Zoom, Netherlands, 4624 VT
    • Not yet recruiting
    • Bravis Ziekenhuis
  • Breda, Netherlands, 4818 CK
    • Not yet recruiting
    • Amphia Ziekenhuis, Molengracht
  • Groningen, Netherlands, 9713GZ
    • Not yet recruiting
    • Universitair Medisch Centrum Groningen
• Poland
  • Gdansk, Poland, 80-546
    • Not yet recruiting
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Katowice, Poland, 40-081
    • Not yet recruiting
    • Centrum Medyczne Pratia Katowice I
  • Krakow, Poland, 30-002
    • Not yet recruiting
    • Centrum Medyczne Pratia Krakow
  • Krakow, Poland, 30-033
    • Not yet recruiting
    • Centrum Medyczne All-Med
  • Lodz, Poland, 90-302
    • Not yet recruiting
    • Santa Familia Centrum Badan, Profilaktyki I Leczenia
  • Lublin, Poland, 20-412
    • Not yet recruiting
    • Etg Lublin
  • Ostrowiec, Poland, 27-400
    • Not yet recruiting
    • Dermedic Dr. Zdybski
  • Poznan, Poland, 60-529
    • Not yet recruiting
    • Solumed Centrum Medyczne
  • Szczecin, Poland, 71-434
    • Not yet recruiting
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 02-625
    • Not yet recruiting
    • Centrum Medyczne Evimed
  • Warszawa, Poland, 02-953
    • Not yet recruiting
    • Klinika Ambroziak
  • Wrocław, Poland, 51-503
    • Not yet recruiting
    • Dermmedica Sp. Z O.O.
• Spain
  • Badalona, Spain, 08916
    • Not yet recruiting
    • Ceim Hospital Universitari Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Not yet recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28046
    • Not yet recruiting
    • Hospital Universitario de La Paz
  • Madrid, Spain, 28031
    • Not yet recruiting
    • Hospital Infanta Leonor
  • Manises, Spain, 46940
    • Not yet recruiting
    • Hospital de Manises
  • Villajoyosa, Spain, 03570
    • Not yet recruiting
    • Hospital Marina Baixa
• Switzerland
  • Basel, Switzerland, 04031
    • Not yet recruiting
    • Universitatsspital Basel
  • Bern, Switzerland, 03010
    • Not yet recruiting
    • Inselspital Universitatsklinik Fur Medizinische Onkologie
  • Buochs, Switzerland, 06374
    • Not yet recruiting
    • Dermatology & Skin Care Clinic
  • Zuerich, Switzerland, 08091
    • Not yet recruiting
    • Universitatsspital Zurich
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Not yet recruiting
    • Bristol Royal Infirmary
  • Isleworth, United Kingdom, TW7 6AF
    • Not yet recruiting
    • West Middlesex University Hospital
  • London, United Kingdom, SE1 9RT
    • Not yet recruiting
    • Guys Hospital
  • Northampton, United Kingdom, NN1 5BD
    • Not yet recruiting
    • Northampton General Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Not yet recruiting
    • University Hospital Plymouth
  • Walsall, United Kingdom, WS2 9PS
    • Not yet recruiting
    • Walsall Manor Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Not yet recruiting
      • Lynn Institute of the Ozarks
  • California
    • Fountain Valley, California, United States, 92708
      • Not yet recruiting
      • First Oc Dermatology
    • Fremont, California, United States, 94538
      • Not yet recruiting
      • Center For Dermatology Cosmetic and Laser Surgery
    • San Diego, California, United States, 92103
      • Not yet recruiting
      • Medderm Associates, Inc
  • Florida
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Encore Medical Research, Llc Hollywood
    • Miami, Florida, United States, 33176
      • Recruiting
      • Entrust Clinical Research
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Not yet recruiting
      • Lane Dermatology and Dermatologic Surgery
    • Marietta, Georgia, United States, 30060-1047
      • Not yet recruiting
      • Marietta Dermatology the Skin Cancer Center Marietta
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Recruiting
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • Not yet recruiting
      • NorthShore University Healthsystem
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Not yet recruiting
      • Oakland Hills Dermatology Pc
    • Troy, Michigan, United States, 48084
      • Not yet recruiting
      • Revival Research Institute, Llc Troy
  • Ohio
    • Gahanna, Ohio, United States, 43230
      • Withdrawn
      • Ohio State University-Wexner Medical Center
  • Pennsylvania
    • Sugarloaf, Pennsylvania, United States, 18249
      • Not yet recruiting
      • Dermdox Center For Dermatology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Withdrawn
      • Medical University of South Carolina
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Not yet recruiting
      • International Clinical Research Tennessee Llc
  • Texas
    • Plano, Texas, United States, 75025
      • Not yet recruiting
      • Texas Dermatology Research Center
    • San Antonio, Texas, United States, 78212
      • Not yet recruiting
      • Rainey and Finklea Dermatology
    • Webster, Texas, United States, 77598
      • Not yet recruiting
      • Center For Clinical Studies Webster
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Recruiting
      • North Sound Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ruxolitinib Cream; Ruxolitinib cream applied topically to the affected area as a thin film twice daily.; Other Names: INCB018424 Phosphate Cream
Placebo Comparator: 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.	Drug: Vehicle Cream; Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Experimental: 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.	Drug: Ruxolitinib Cream; Ruxolitinib cream applied topically to the affected area as a thin film twice daily.; Other Names: INCB018424 Phosphate Cream
Placebo Comparator: 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.	Drug: Vehicle Cream; Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Experimental: 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.	Drug: Ruxolitinib Cream; Ruxolitinib cream applied topically to the affected area as a thin film twice daily.; Other Names: INCB018424 Phosphate Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Week 8
VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Day 7
VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Day 3
VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Day 2
VC Period: Number of Treatment Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.	Up to Week 24, followed by 30 days follow-up
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 Weeks 2 and 4
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 Weeks 2 and 4
VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Weeks 2 and 4
VC Period: Time to achieve a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)	ITCH4 is defined as achieving ≥ 4-point improvement in Itch NRS score.	Baseline to Week 8
VC Period: Time to achieve ≥ 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2)	ITCH2 is defined as achieving ≥ 2-point improvement from baseline in Itch NRS score.	Baseline to Week 8
VC Period: Change from baseline (pre-study cream application) in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.		Baseline to Day 1
VC Period: Proportion of participants achieving at least a 2-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.		Baseline to Day 1
VC Period: Proportion of participants achieving at least a 4-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.		Baseline to Day 1
VC and VCE Periods: Proportion of participants who achieved EASI50	Defined as ≥ 50% improvement in Eczema Area and Severity Index (EASI) score.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Proportion of participants who achieved EASI90	Defined as ≥ 90% improvement in Eczema Area and Severity Index (EASI) score.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS	Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score and IGA score of 0 or 1 with ≥ 2 grade improvement from baseline.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)	A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in EASI score	A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in SCORAD score	SCORing Atopic Dermatitis - tool used to assess extent and severity (intensity) of eczema.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in Itch NRS score	The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in Skin Pain NRS score	The Skin Pain NRS is a daily participant-reported measure (24-hour or 7-day recall) of the worst level of pain intensity from 0 (no pain) to 10 (worst pain imaginable.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VCE Period: Time to open-label escape arm	Defined as not achieving 50% improvement in EASI score from baseline at 2 consecutive visits at least 1 week apart.	Baseline to Week 24
VC and VCE Periods: Proportion of participants concurrently meeting all of the following criteria: IGA score ≥ 3, EASI score ≥ 16, Itch NRS score ≥ 4, BSA ≥ 10%, and DLQI score > 10		Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Time to concurrently meeting all of the following criteria: IGA score ≥ 3, EASI score ≥ 16, Itch NRS score ≥ 4, BSA ≥ 10%, and DLQI score > 10		Baseline to Week 24
VC Period: Proportion of participants who experience a relapse after study treatment discontinuation	Defined as proportion of participants among EASI75 responders who are on study treatment at Week 24 who meet relapse criteria [loss of EASI50 from baseline] at the safety follow-up visit.	Week 24 to Follow-up (30 days)
VCE period: Time to first re-treatment		Week 8 to Week 24
VCE Period: Proportion of time off study treatment due to lesion clearance		Week 8 to Week 24
VCE period: Proportion of time on study treatment		Week 8 to Week 24
VC and VCE Periods: Proportion of participants who achieve ≥ 4-point improvement in DLQI from baseline	The DLQI is a 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The participant will answer the questionnaire with either (1) very much, (2) a lot, (3) a little, or (4) not at all. A negative change from Baseline indicates less impact of the skin problem on participant's life.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score	The DLQI is a 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The participant will answer the questionnaire with either (1) very much, (2) a lot, (3) a little, or (4) not at all. A negative change from Baseline indicates less impact of the skin problem on participant's life.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score	The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score	he EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in the HADS scores	The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire to be completed by tablet; the questionnaire assesses the levels of anxiety and depression a person is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). Separate scores are calculated for anxiety and depression. The recall period will be the past 7 days for both the VC and VCE periods.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score	The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score	The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD)	The WPAI-AD questionnaire is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and regular activities outside of it during the past 7 days.	Baseline to Week 8 and Week 24

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: eczema; topical therapy; Atopic dermatitis; pruritus; JAK inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: INCB18424-326; 2023-505433-27-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No