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

Atopic Dermatitis Clinical Trial

— BREEZE-AD2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334422
• Other study ID #: 16581
• Secondary ID: I4V-MC-JAHM2017-
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2017
• Est. completion date: December 12, 2018

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: 615
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 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
Argentina	Fundacion CIDEA	Buenos Aires
Argentina	Instituto de Neumonología y Dermatología	Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Buenos Aires
Argentina	CENIT Centro de Neurociencias, Investigación y Tratamiento	Caba	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Clinica Adventista de Belgrano	Ciudad de Buenos Aires	Buenos Aires
Argentina	Parra Dermatología	Mendoza
Australia	Clinical Trials SA Pty Ltd	Adelaide	South Australia
Australia	Skin and Cancer Foundation Inc.	Carlton	Victoria
Australia	Fremantle Dermatology	Perth	Western Australia
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Skin & Cancer Foundation Australia	Westmead	New South Wales
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Austria	Ordensklinikum Linz GmbH - Elisabethinen	Linz	Oberösterreich
Austria	AKH	Wien
Austria	KA Rudolfstiftung	Wien
Austria	KH Hietzing mit neurologischem Zentrum Rosenhügel	Wien
Austria	Sozialmed. Zentrum Ost - Donauspital	Wien
Hungary	UNO Medical Trials Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika	Debrecen	Hajdu-Bihar
Hungary	Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Oroshaza Varosi Onkormanyzat Korhaza	Oroshaza
Hungary	Trial Pharma Kft.	Puspokladany	Hajdu-Bihar
Hungary	SZTE AOK Borgyogyaszati es Allergologiai Klinika	Szeged	Csongrad
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jasz-Nagykun-Szolnok
Hungary	Markusovszky Korhaz	Szombathely
Hungary	MedMare Bt	Veszprem
Israel	Haemek Medical Center- Dermatology	Afula
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center - Ein Karem	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Japan	Yanagihara dermatology clinic	Ainokawa, Ichikawa-shi	Chiba
Japan	Tokyo Teishin Hospital	Chiyoda-Ku	Tokyo
Japan	Gifu University Hospital	Gifu
Japan	Osaka Habikino Medical Center	Habikino	Osaka
Japan	Tokyo Medical University Ibaraki Medical Center	Inashiki-gun	Ibaraki
Japan	Noguchi Dermatology	Kashima-machi, Kamimashiki-gun	Kumamoto
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Yoshioka Dermatology Clinic	Neyagawa-shi	Osaka
Japan	Sanrui Dermatology Clinic	Ohmiya-ku,Saitama-shi	Saitama
Japan	Osaka City University Hospital	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Naoko Dermatology Clinic	Setagaya-ku	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Yamate Dermatological Clinic	Shinjuku	Tokyo
Japan	Tachikawa Dermatology Clinic	Tachikawa-shi	Tokyo
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Korea
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Hallym University of Medicine	Seoul
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi Do
Poland	NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm	Bialystok
Poland	Centrum Badan Klinicznych, PI House	Gdansk
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	Barbara Rewerska DIAMOND CLINIC	Krakow
Poland	"Dermed" Centrum Medyczne Sp. z o.o.	Lodz
Poland	Miejski Szpital Zespolony w Olsztynie	Olsztyn
Poland	DermoDent, Centrum Medyczne Czajkowscy	Osielsko
Poland	LASER CLINIC S.C. Dr Tomasz Kochanowski, Dr Andrzej Krolicki	Szczecin
Poland	Wojskowy Instytut Medyczny	Warsaw
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Spain	Hospital General Universitario Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Barcelona	Badalona
Spain	Hospital De Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Mostoles	Madrid
Spain	Clinica Universitaria De Navarra	Pamplona	Navarra
Spain	Centro de Especialidades Mollabao	Pontevedra
Switzerland	Inselspital Bern	Bern
Switzerland	HUG-Hôpitaux Universitaires de Genève	Genève
Switzerland	CHUV Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Hungary,  Israel,  Japan,  Korea, Republic of,  Poland,  Spain,  Switzerland, 

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, 2mg and 4mg Baricitinib)	The IGA measures the investigator's global assessment of the participants 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, 1mg Baricitinib)	The IGA measures the investigator's global assessment of the participants 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 is 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 is 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 on 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 is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).; Least Square (LS) Means were calculated using a mixed model repeated measures (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 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 VAS where 0 is no itching or no trouble sleeping and 10 is unbearable Itching or 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 Skin Pain 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.; LSMean was 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 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 (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 EASI 50 is defined as =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 participants 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 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. LSMeans was calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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 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 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.; LSMean 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.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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, ie, "(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 items 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.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects.	Baseline, 16 Weeks
Secondary	Change From Baseline on the Dermatology Life Quality Index (DLQI)	The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 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 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.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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. LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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. A higher score indicates better health state.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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.; LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. 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 participants 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-AD2)