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

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Phillip, Australia, 02606
    • Paratus Clinical Research, Woden
  • New South Wales
    • Kogarah, New South Wales, Australia, 02217
      • Premier Specialists Pty Ltd
    • Maroubra, New South Wales, Australia, 02035
      • Australian Clinical Research Network
  • Queensland
    • Woolloongabba, Queensland, Australia, 04102
      • Veracity Clinical Research
  • South Australia
    • Campbelltown, South Australia, Australia, 05074
      • Clinical Trials Sa
  • Victoria
    • Carlton, Victoria, Australia, 03053
      • Skin Health Institute Inc.
• Belgium
  • Brussels, Belgium, 01200
    • Cliniques Universitaires Ucl Saint-Luc
  • Brussels, Belgium, 01070
    • Ulb Hospital Erasme
  • Edegem, Belgium, 02650
    • Universitair Ziekenhuis Antwerpen (UZA)
  • Ghent, Belgium, 09000
    • Universitair Ziekenhuis Gent (Uz Gent)
  • Gilly, Belgium, 06060
    • Grand Hôpital de Charleroi
  • Kortrijk, Belgium, 08500
    • Dermatologie Handelskaai
• Bulgaria
  • Gabrovo, Bulgaria, 05300
    • MHAT Dr. Tota Venkova AD
  • Pleven, Bulgaria, 05800
    • Medical center Medconsult Pleven OOD
  • Sofia, Bulgaria, 01431
    • DCC 'Alexandrovska', EOOD
  • Sofia, Bulgaria, 01510
    • Medical Center Hera EOOD
  • Sofia, Bulgaria, 01407
    • Ambulatory for Specialized Medical Help - skin and venereal diseases
  • Sofia, Bulgaria, 01592
    • Diagnostic Consultative Center Xxviii
  • Sofia, Bulgaria, 01618
    • Medical Center Assoc. Prof. Vasilev
• Canada
  • St. John's, Canada, A1E 1V4
    • Skincare Studio Dermatology Centre
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc.
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin Pc Inc.
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique du Quebec metropolitain
• France
  • Lille, France, 59020
    • Ghicl - Hôpital Saint-Vincent de Paul
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Rouen, France, 76000
    • Chu de Rouen - Hospital Charles Nicolle
  • Saint-Etienne, France, 42055
    • University Hospital of Saint Etienne
• Germany
  • Augsburg, Germany, 86179
    • Universitaetsklinikum Augsburg Sued
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim Dermatologie
  • Berlin, Germany, 13055
    • Praxis Fuer Haut- Und Geschlechtskrankheiten Dr. Med. Thomas Wildfeuer Und Partner
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Potsdam, Germany, 14467
    • Dermatologie Potsdam Mvz Gmbh
• Hungary
  • Budapest, Hungary, 01085
    • Semmelweis Egyetem
  • Budapest, Hungary, 01033
    • Clinexpert Kft.
  • Budapest, Hungary, 01036
    • Obudai Egeszsegugyi Centrum Kft.
  • Debrecen, Hungary, 04032
    • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
  • Szeged, Hungary, 06720
    • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
• Italy
  • Milan, Italy, 20122
    • Fondazione Irccs Ca Granda Ospedale Maggiore
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Naples, Italy, 80131
    • Università degli Studi della Campania Luigi Vanvitelli
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Rozzano, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
• Netherlands
  • Bergen op Zoom, Netherlands, 4624 VT
    • Bravis Ziekenhuis
  • Breda, Netherlands, 04818
    • Amphia Ziekenhuis, Molengracht
  • Groningen, Netherlands, 9713GZ
    • Universitair Medisch Centrum Groningen
• Poland
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Krakow, Poland, 30-033
    • Centrum Medyczne ALL-MED
  • Krakow, Poland, 30-727
    • Pratia MCM Krakow
  • Lodz, Poland, 90-302
    • Santa Sp. Z O.O. Santa Familia Ptg Lodz
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Poznan, Poland, 60-529
    • SOLUMED Centrum Medyczne
  • Szczecin, Poland, 71- 500
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warsaw, Poland, 02-625
    • Centrum Medyczne Evimed
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak Dermatologia
  • Wroclaw, Poland, 51-503
    • dermMedica Sp. z o.o.
• Spain
  • Badalona, Spain, 08916
    • Ceim Hospital Universitari Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Hospital de La Santa Creu i Sant Pau
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Manises, Spain, 46940
    • Hospital de Manises
  • Villajoyosa, Spain, 03570
    • Hospital Marina Baixa
• Switzerland
  • Basel, Switzerland, CH-4055
    • Universitätsspital Basel
  • Bern, Switzerland, 03010
    • Inselspital Universitatsklinik Fur Medizinische Onkologie
  • Buochs, Switzerland, 06374
    • Dermatology & Skin Care Clinic
  • Zurich, Switzerland, 08091
    • Universitätsspital Zürich
• United Kingdom
  • Isleworth, United Kingdom, TW7 6AF
    • West Middlesex University Hospital
  • London, United Kingdom, SE1 9RT
    • Guys Hospital
  • Northampton, United Kingdom, NN1 5BD
    • Northampton General Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • University Hospital Plymouth
  • Walsall, United Kingdom, WS2 9PS
    • Walsall Manor Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Lynn Institute of the Ozarks
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center For Dermatology Cosmetic and Laser Surgery
    • San Diego, California, United States, 92103
      • Medderm Associates, Inc
  • Florida
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research, Llc Hollywood
    • Miami, Florida, United States, 33176
      • Entrust Clinical Research
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Lane Dermatology and Dermatologic Surgery
    • Marietta, Georgia, United States, 30060
      • Marietta Dermatology the Skin Cancer Center Marietta
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • Northshore University Healthsystem
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology PC
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, Llc Troy
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Best Skin Research
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies Webster
    • Plano, Texas, United States, 75025
      • Texas Dermatology Research Center
    • San Antonio, Texas, United States, 78213
      • Rainey and Finklea Dermatology
  • Washington
    • Mill Creek, Washington, United States, 98012
      • 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
Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8	EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe.	Baseline; Week 8
Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8	IGA-TS was defined as achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline. The IGA is an overall eczema severity rating on a 0 to 4 scale. 0: clear; no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1: almost clear; may be trace faint pink erythema, with almost no induration/papulation, and no oozing/crusting. 2: mild; may be faint pink erythema, with mild induration/papulation and no oozing/crusting. 3: moderate; may be pink-red erythema with moderate induration/papulation and may be some oozing/crusting. 4: severe; may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.	Baseline; Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving a ≥4-point Improvement in Itch Numeric Rating Scale (NRS) Score (ITCH4) From Baseline to Week 8	Baseline; Week 8
Percentage of Participants Achieving ITCH4 From Baseline to Days 2, 3, and 7	Baseline; Days 2, 3, and 7
Vehicle-controlled (VC) Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE )	up to Week 12
Vehicle-controlled Extension Double-blind (VCE DB) Period: Number of Participants With Any TEAE	up to 16 weeks (from Week 8 to Week 24)
VCE Escape Arm: Number of Participants With Any TEAE	up to 150 days
VC Period: Number of Participants With Any ≥Grade 3 TEAE	up to Week 12
VCE DB Period: Number of Participants With Any ≥Grade 3 TEAE	up to 16 weeks (from Week 8 to Week 24)
VCE Escape Arm: Number of Participants With Any ≥Grade 3 TEAE	up to 150 days
Double-blind Treatment Period: Percentage of Participants Achieving EASI75 From Baseline at Weeks 2, 4, 12, 16, 20, and 24	Baseline; Weeks 2, 4, 12, 16, 20, and 24
VCE Escape Arm: Percentage of Participants Achieving EASI75 From Baseline at Weeks 12, 16, 20, and 24	Baseline; Weeks 12, 16, 20, and 24
Double-blind Treatment Period: Percentage of Participants With IGA-TS From Baseline at Each Postbaseline Visit Except Week 8	Baseline; Weeks 2, 4, 12, 16, 20, and 24
VCE Escape Arm: Percentage of Participants With IGA-TS From Baseline at Weeks 12, 16, 20, and 24	Baseline; Weeks 12, 16, 20, and 24
Percentage of Participants Achieving ITCH4 From Baseline to Weeks 2 and 4	Baseline; Weeks 2 and 4
Time to Achieve ITCH4 During the VC Period	up to Week 8
Time to Achieve ITCH2 During the VC Period	up to Week 8
Change 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; Day 1
Percentage 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; Day 1
Percentage 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; Day 1
Double-blind Treatment Period: Percentage of Participants Achieving EASI50 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24	Baseline; Weeks 2, 4, 12, 16, 20, and 24
Double-blind Treatment Period: Percentage of Participants With EASI90 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24	Baseline; Weeks 2, 4, 12, 16, 20, and 24
Double-blind Treatment Period: Percentage of Participants Achieving Both EASI75 and IGA-TS at Weeks 2, 4, 8, 12, 16, 20, and 24	Baseline; Weeks 2, 4, 12, 16, 20, and 24
Change From Baseline for Atopic Dermatitis-affected %Body Surface Area (BSA) at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline for Atopic Dermatitis-affected %BSA at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline for the EASI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline for the EASI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline for the SCORing Atopic Dermatitis (SCORAD) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline for the SCORAD Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline for Itch NRS Score at Days 1 Through 56 (8 Weeks)	Baseline; Days 1 through 56 (8 weeks)
Change From Baseline for Skin Pain NRS Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline for Skin Pain NRS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Time to Open-label Escape Arm	up to 16 weeks (from Week 8 to Week 24)
Percentage of Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score, ≥4, BSA ≥10%, and Dermatology Life Quality Index (DLQI) Score >10	up to 16 weeks (from Week 8 to Week 24)
Time to Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score ≥4, BSA ≥10%, and DLQI Score >10	up to 16 weeks (from Week 8 to Week 24)
Percentage of Participants Who Experienced a Relapse After Study Treatment Discontinuation	up to 30 days following Week 24
Time to First Retreatment During the VCE DB Period	up to 16 weeks (from Week 8 to Week 24)
Percentage of Time Off Study Treatment Due to Lesion Clearance During the VCE DB Period	from Week 8 to Week 24
Percentage of Time on Study Treatment During the VCE DB Period	from Week 8 to Week 24
Double-blind Treatment Period: Percentage of Participants Who Achieved a ≥4-point Improvement in Dermatology Life Quality Index (DLQI) From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24	Baseline; Weeks 2, 4, 12, 16, 20, and 24
Change From Baseline in the DLQI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline in the DLQI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the Patient-oriented Eczema Measure (POEM) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline in the POEM Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period	Baseline; Weeks 2, 4, and 8
Change From Baseline in the HADS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 2, 4, and 8	Baseline; Weeks 2, 4, and 8
Change From Baseline in the PROMIS Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 12, 16, 20, and 24	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 2, 4, and 8	Baseline; Weeks 2, 4, and 8
Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 12, 16, 20, and 24	Baseline; Weeks 12, 16, 20, and 24
Change From Baseline in the Work Productivity and Activity Impairment Questionairre-Atopic Dermatitis (WPAI-AD) Score at Weeks 8 and 24	Baseline; Weeks 8 and 24

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): October 17, 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 (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: eczema; topical therapy; Atopic dermatitis; pruritus; JAK inhibitor
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis, Atopic; Eczema; Pruritus
• 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