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

Atopic Dermatitis Clinical Trial

— TRuE-AD4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238817
• Other study ID #: INCB18424-326
• Secondary ID: 2023-505433-27-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 26, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: October 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
• Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc.	Carlton	Victoria
Australia	Clinical Trials Sa	Hectorville	South Australia
Australia	Premier Specialists Pty Ltd	Kogarah	New South Wales
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Paratus Clinical Research, Woden	Phillip
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Belgium	Ulb Hospital Erasme	Bruxelles
Belgium	Universitair Ziekenhuis Antwerpen (Uza)	Edegem
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Dermatologie Handelskaai	Kortrijk
Belgium	Grand Hopital de Charleroi	Loverval
Bulgaria	Mhat Dr. Tota Venkova Ad	Gabrovo
Bulgaria	Dcc 'Sveti Georgi' Eood	Haskovo
Bulgaria	Medical Center Medconsult Pleven Ood	Pleven
Bulgaria	Ambulatory For Specialized Medical Help - Skin and Venereal Diseases	Sofia
Bulgaria	Dcc 'Alexandrovska', Eood	Sofia
Bulgaria	Dcc Xxviii	Sofia
Bulgaria	Medical Center Assoc. Prof. Vasilev	Sofia
Bulgaria	Medical Center Hera Eood	Sofia
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	Brunswick Dermatology Center	Fredericton	New Brunswick
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Skin Centre For Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique Du Quebec Metropolitain	Quebec
Canada	Skincare Studio Dermatology Centre	St. John's	Newfoundland and Labrador
Canada	Dr. Chih-Ho Hong Medical Inc.	Surrey	British Columbia
Canada	Wiseman Dermatology Research Inc	Winnipeg	Manitoba
France	Centre Hospitalier Du Mans	Le Mans Cedex
France	Chru de Lille Hopital Claude Huriez	Lille Cedex
France	Ghicl - Hôpital Saint-Vincent de Paul	Lille Cedex
France	Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu	Nantes
France	Hospices Civils de Lyon Centre Hospitalier Lyon Sud	Pierre Bénite Cedex
France	Chu de Rouen - Hospital Charles Nicolle	Rouen
France	University Hospital of Saint Etienne	Saint Etienne Cedex 2
Germany	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	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitatsklinikum Munster	Muenster
Germany	Dermatologie Potsdam Mvz Gmbh	Potsdam
Hungary	Clinexpert Kft.	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika	Debrecen
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Hungary	Medmare Bt	Veszprem
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari	Bari
Italy	Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria 'Federico Ii'	Naples
Italy	Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli	Napoli
Italy	Fondazione Policlinico Universitario Agostino Gemelli Irccs	Roma
Italy	Irccs Istituto Clinico Humanitas	Rozzano
Korea, Republic of	Soon Chun Hyang University Hospital (Schuh) Bucheon	Bucheon
Korea, Republic of	Konkuk University Medical Center	Seoul
Netherlands	Bravis Ziekenhuis	Bergen Op Zoom
Netherlands	Amphia Ziekenhuis, Molengracht	Breda
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Poland	Centrum Badan Klinicznych Pi-House Sp. Z O.O.	Gdansk
Poland	Centrum Medyczne Pratia Katowice I	Katowice
Poland	Centrum Medyczne All-Med	Krakow
Poland	Centrum Medyczne Pratia Krakow	Krakow
Poland	Santa Familia Centrum Badan, Profilaktyki I Leczenia	Lodz
Poland	Etg Lublin	Lublin
Poland	Dermedic Dr. Zdybski	Ostrowiec
Poland	Solumed Centrum Medyczne	Poznan
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Centrum Medyczne Evimed	Warszawa
Poland	Klinika Ambroziak	Warszawa
Poland	Dermmedica Sp. Z O.O.	Wroclaw
Spain	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
Switzerland	Universitatsspital Basel	Basel
Switzerland	Inselspital Universitatsklinik Fur Medizinische Onkologie	Bern
Switzerland	Dermatology & Skin Care Clinic	Buochs
Switzerland	Universitatsspital Zurich	Zuerich
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	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 States	Oakland Hills Dermatology Pc	Auburn Hills	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Lane Dermatology and Dermatologic Surgery	Columbus	Georgia
United States	First Oc Dermatology	Fountain Valley	California
United States	Center For Dermatology Cosmetic and Laser Surgery	Fremont	California
United States	Ohio State University-Wexner Medical Center	Gahanna	Ohio
United States	Encore Medical Research, Llc Hollywood	Hollywood	Florida
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Marietta Dermatology the Skin Cancer Center Marietta	Marietta	Georgia
United States	Entrust Clinical Research	Miami	Florida
United States	North Sound Dermatology	Mill Creek	Washington
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Texas Dermatology Research Center	Plano	Texas
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Rainey and Finklea Dermatology	San Antonio	Texas
United States	Medderm Associates, Inc	San Diego	California
United States	Northshore University Healthsystem	Skokie	Illinois
United States	Dermdox Center For Dermatology	Sugarloaf	Pennsylvania
United States	Revival Research Institute, Llc Troy	Troy	Michigan
United States	Center For Clinical Studies Webster	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	VCE period: Time to first re-treatment		Week 8 to Week 24
Secondary	VCE Period: Proportion of time off study treatment due to lesion clearance		Week 8 to Week 24
Secondary	VCE period: Proportion of time on study treatment		Week 8 to Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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