A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— BREEZE-AD1  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334396
• Other study ID #: 16580
• Secondary ID: I4V-MC-JAHL2017-
• Status: Completed
• Phase: Phase 3
• Start date: November 23, 2017
• Est. completion date: August 16, 2019

Study information

• Verified date: January 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: August 16, 2019
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.

• Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.

• Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

• Agree to use emollients daily.

Exclusion Criteria:

• Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.

• A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.

• Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.

• Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).

• Have been treated with the following therapies:

• Monoclonal antibody for less than 5 half-lives prior to randomization.

• Received prior treatment with any oral Janus kinase (JAK) inhibitor.

• Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.

• Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.

• Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.

• Have had major surgery within the past eight weeks or are planning major surgery during the study.

• Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.

• Have a history of recurrent (= 2) VTE or are considered at high risk of VTE as deemed by the investigator.

• Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.

• Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.

• Have specific laboratory abnormalities.

• Have received certain treatments that are contraindicated.

• Pregnant or breastfeeding.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Baricitinib
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Czechia	Fakultni Nemocnice U svate Anny	Brno	Jihomoravský Kraj
Czechia	Kozni ambulance Kutna Hora, s.r.o.	Kutna Hora	Stredocesky Kraj
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin	Moravskoslezsky Kraj
Czechia	Fakultni Nemocnice Plzen	Plzen, Jizni Predmesti	Plzensky Kraj
Czechia	Clintrial, s.r.o.	Praha 10	Hl. M. Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10	Hl. M. Praha
Czechia	Fakultni Nemocnice v Motole	Praha 5	Hl. M. Praha
Czechia	Nemocnice Na Bulovce	Praha 8	Hl. M. Praha
Czechia	Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem	Ustecký Kraj
Denmark	Aarhus Universitehospital Marselisborg Centret	Aarhus
France	CHU de Bordeaux Hopital Saint Andre	Bordeaux Cedex
France	CHRU de Brest - Hôpital Morvan	Brest
France	CHU Grenoble Alpes	Grenoble Cédex 9
France	Chru De Nantes Hotel-Dieu	Nantes Cedex 1
France	CHU de Nice Hopital de L'Archet	Nice cedex 3
France	Hopital Saint-Louis	Paris	Cedex 10
France	Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	Hopital Larrey	Toulouse
Germany	ISA GmbH	Berlin
Germany	Praxis für Ganzheitliche Dermatologie im Ärztehaus	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Gemeinschaftspraxis Mahlow	Blankenfelde-Mahlow	Brandenburg
Germany	Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen
Germany	Dermatologisches Zentrum Osnabrück Nord	Bramsche	Niedersachsen
Germany	Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH	Darmstadt	Hessen
Germany	Praxis Gerlach	Dresden	Sachsen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	Universitätsklinikum Freiburg	Freiburg im Breisgau	Baden-Württemberg
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Hautarztzentrum Kiel	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Universität Leipzig - Universitätsklinikum	Leipzig	Sachsen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Otto-von-Guericke-Universität	Magdeburg	Sachsen-Anhalt
Germany	Klinikum der Universität München	München	Bayern
Germany	Universitätsmedizin Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Praxis Dr. Thomas Dirschka	Wuppertal	Nordrhein-Westfalen
India	Byramjee Jeejeebhoy Medical College & Civil Hospital	Ahmedabad	Gujarat
India	Panchshil Hospital	Ahmedabad	Gujarat
India	M S Ramaiah Medical College Hospital	Bangalore	Karnataka
India	Chennai Meenakshi Multispeciality Hospital	Chennai	Tamil Nadu
India	MV Hospital and Research Centre	Lucknow	Uttar Pradesh
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharshtra
India	Dr. D. Y. Patil Medical College & Hospital	Navi Mumbai	Maharashtra
India	All India Institue of Medical Sciences (AIIMS)	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Jehangir Hospital	Pune	Maharashtra
India	Gandhi Hospital	Secunderabad	Telangana
India	King George Hospital	Vizag	Andhra Pradesh
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera - Universitaria Pisana	Pisa
Italy	Policlinico di Tor Vergata	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale Policlinico Giambattista Rossi, Borgo Roma	Verona
Japan	Iidabashi Clinic	Chiyoda-ku	Tokyo
Japan	Nihonbashi Sakura Clinic	Chuo-ku	Tokyo
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Fukuoka University Hospital	Fukuoka
Japan	Fumimori Clinic	Fukuoka-shi	Fukuoka
Japan	JA Shizuoka Kohseiren Enshu Hospital	Hamamatsu-shi	Shizuoka
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-ken
Japan	Kawashima Dermatology Clinic	Ichikawa-shi	Chiba
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Kume Clinic	Nishi-ku Sakai-shi	Osaka
Japan	Queen's Square Dermatology and Allergology	Nishi-ku, Yokohama-city	Kanagawa
Japan	NTT Medical Center Tokyo	Shinagawa-KU	Tokyo
Japan	Shirasaki Clinic	Takaoka-shi	Toyama
Japan	Yokohama City Minato Red Cross Hospital	Yokohama-shi	Kanagawa
Mexico	JM Research S.C.	Cuernavaca
Mexico	RM Pharma Specialists S.A. de C.V.	Distrito Federal
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C	Durango
Mexico	Hospital de Jesus I.A.P.	Mexico City	Distrito Federal
Mexico	Grupo Médico CAMINO S.C.	México City	Distrito Federal
Mexico	CRI Centro Regiomontano de Investigacion S.C.	Monterrey	Nuevo Leon
Mexico	Hospital Univ. Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Clínica Enfermedades Crónicas y Procedimientos Especiales SC	Morella	Michoacan
Russian Federation	GBUZ Clinical dermatology and venereological dispensary	Krasnodar
Russian Federation	Russian state medical-stomatological university n.a. Evdokimov	Moscow
Russian Federation	State scientific centre for dermatovenerology and cosmetolog	Moscow
Russian Federation	LLC ArsVitae NorthWest	Saint-Petersburg
Russian Federation	LLC Medical Center "Kurator"	Saint-Petersburg
Russian Federation	SPb SBHI Skin-venerologic dispensary #10	St. Petersburg
Taiwan	Chang Gung Memorial Hospital - Kaohsiung	Kaohsiung City
Taiwan	Taipei Medical University- Shuang Ho Hospital	New Taipei City
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	Chang Gung Memorial Hospital - Taipei	Taipei City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

Czechia,  Denmark,  France,  Germany,  India,  Italy,  Japan,  Mexico,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)	The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	16 Weeks
Secondary	Percentage of Participants Achieving IGA of 0 or 1 With a = 2 Point Improvement (Placebo, 1 mg Baricitinib)	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	16 Weeks
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a = 75% improvement from baseline in the EASI score.	16 Weeks
Secondary	Percentage of Participants Achieving EASI90	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a = 90% improvement from baseline in the EASI score.	16 Weeks
Secondary	Percent Change From Baseline in EASI Score	The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).; Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect	Baseline, 16 Weeks
Secondary	Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)	The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a = 75% improvement from baseline in the SCORAD score.	16 Weeks
Secondary	Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)	The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.	16 Weeks
Secondary	Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)	Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)	Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Percentage of Participants Achieving EASI50	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a = 50% improvement from baseline in EASI score.	16 Weeks
Secondary	Percentage of Participants Achieving IGA of 0	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	16 Weeks
Secondary	Change From Baseline in SCORAD	The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Percentage of Participants Achieving SCORAD90	The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a = 90% improvement from baseline in the SCORAD score.	16 Weeks
Secondary	Change From Baseline in Body Surface Area (BSA) Affected	Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.; LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment	Percentage of participants developing skin infections requiring antibiotic treatment.	16 Weeks
Secondary	Percent Change From Baseline in Itch NRS	The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score	The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)	The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline in the Dermatology Life Quality Index (DLQI)	The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire	The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.; LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm	EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.; LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)	EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.; LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a = 2 Point Improvement	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	4 Weeks

External Links

•   A Study of Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis (Eczema) (BREEZE-AD1)