A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— BREEZE-AD3  

Official title:

A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334435
• Other study ID #: 16587
• Secondary ID: I4V-MC-JAHN2017-
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2018
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• 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 long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1645
• Est. completion date: July 12, 2023
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:

Exclusion Criteria:

• Had investigational product permanently discontinued at any time during a previous Baricitinib study.
• Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study OR Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:

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	Centro de Investigaciones Metabólicas (CINME)	Buenos Aires
Argentina	CEDIC-Centro de Investigaciones Clinicas	Caba	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	Fundacion CIDEA	Ciudad Autonoma Buenos Aires
Argentina	Instituto de Neumonología y Dermatología	Ciudad Autonoma Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Ciudad Autonoma Buenos Aires
Argentina	Parra Dermatología	Mendoza
Australia	Clinical Trials SA Pty Ltd	Adelaide	South Australia
Australia	The Skin Centre	Benowa	Queensland
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	Universitätsklinikum Graz	Graz	Steiermark
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
Czechia	Fakultni Nemocnice U svate Anny	Brno	Jihomoravský Kraj
Czechia	Kozni ambulance Kutna Hora, s.r.o.	Kutna Hora	Stredoceský Kraj
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin	Moravskoslezsky Kraj
Czechia	Fakultni Nemocnice Plzen	Plzen-Bory	Plzenský 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	Region Midtjyland
Denmark	Gentofte Hospital	Hellerup	Region Hovedstaden
France	CHU de Bordeaux Hopital Saint Andre	Bordeaux Cedex
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	Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik	Aachen
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	ISA GmbH	Berlin
Germany	Praxis für Ganzheitliche Dermatologie im Ärztehaus	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Gemeinschaftspraxis Mahlow	Blankenfelde-Mahlow	Brandenburg
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	Universitaetsklinikum Essen	Essen	Nordrhein-Westfalen
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	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
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
Hungary	UNO Medical Trials Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika	Debrecen	Hajdu-Bihar
Hungary	Kaposi Mor Oktato Korhaz	Kaposvar	Somogy
Hungary	Oroshaza Varosi Onkormanyzat Korhaza	Oroshaza	Bekes
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	Vas
Hungary	MedMare Bt	Veszprem
India	Byramjee Jeejeebhoy Medical College & Civil Hospital	Ahmedabad	Gujarat
India	Panchshil Hospital	Ahmedabad	Gujarat
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	Gandhi Hospital	Secunderabad	Telangana
India	King George Hospital	Vizag	Andhra Pradesh
Israel	Haemek Medical Center- Dermatology	Afula
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera Universitaria Ospedale San Martino di Genova	Genova
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera - Universitaria Pisana	Pisa
Italy	Policlinico di Tor Vergata	Roma
Italy	Policlinico Univ. Agostino Gemelli	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale Policlinico Giambattista Rossi, Borgo Roma	Verona
Italy	ULSS 8	Vicenza
Japan	Yanagihara dermatology clinic	Ainokawa, Ichikawa-shi	Chiba
Japan	Iidabashi Clinic	Chiyoda-ku	Tokyo
Japan	Tokyo Teishin Hospital	Chiyoda-Ku	Tokyo
Japan	Hosono Clinic	Chuo-ku	Tokyo
Japan	Nihonbashi Sakura Clinic	Chuo-ku	Tokyo
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Fumimori Clinic	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital	Gifu
Japan	Osaka Habikino Medical Center	Habikino	Osaka
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	Tokyo Medical University Ibaraki Medical Center	Inashiki-gun	Ibaraki
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Noguchi Dermatology	Kashima-machi, Kamimashiki-gun	Kumamoto
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Medical Corporation Soleil Miyata Dermatology Clinic	Matsudo-shi	Chiba
Japan	Oizumi Hanawa Clinic	Nerima-ku	Tokyo
Japan	Yoshioka Dermatology Clinic	Neyagawa-shi	Osaka
Japan	Kume Clinic	Nishi-ku Sakai-shi	Osaka
Japan	Queen's Square Dermatology and Allergology	Nishi-ku, Yokohama-city	Kanagawa
Japan	Sanrui Dermatology Clinic	Ohmiya-ku,Saitama-shi	Saitama
Japan	Osaka City University Hospital	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Shibaki Dermatology Clinic	Sapporo	Hokkaido
Japan	Naoko Dermatology Clinic	Setagaya-ku	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	NTT Medical Center Tokyo	Shinagawa-KU	Tokyo
Japan	Yamate Dermatological Clinic	Shinjuku	Tokyo
Japan	Tachikawa Dermatology Clinic	Tachikawa-shi	Tokyo
Japan	Shirasaki Clinic	Takaoka-shi	Toyama
Japan	Senri-Chuo Hanafusa Dermatology Clinic	Toyonaka-shi	Osaka
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa
Japan	Yokohama City Minato Red Cross Hospital	Yokohama-shi	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Korea
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	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
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 Medico Camino S.C.	México City	Distrito Federal
Mexico	CRI Centro Regiomontano de Investigacion S.C.	Monterrey	Nuevo Leon
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Clinica De Enfermedades Cronicas y Procedimientos Especiales	Morelia	Michoacan Morelia
Poland	NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych, PI House	Gdansk	Pomorskie
Poland	Centrum Medyczne Angelius Provita	Katowice	Slaskie
Poland	Barbara Rewerska DIAMOND CLINIC	Krakow	Malopolskie
Poland	Dermed Centrum Medyczne Sp. z o.o.	Lodz	Lodzkie
Poland	Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii	Olsztyn	Warminsko-mazurskie
Poland	DermoDent, Centrum Medyczne Czajkowscy	Osielsko	Kujawsko-pomorskie
Poland	Lubelskie Centrum Diagnostyczne	Swidnik	Lubelskie
Poland	LASER CLINIC Specjalistyczne Gabinety Lekarskie	Szczecin	Zachodniopomorskie
Poland	Wojskowy Instytut Medyczny CSK MON	Warsaw	Mazowieckie
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa	Mazowieckie
Poland	Centrum Medyczne AMED	Warszawa	Mazowieckie
Poland	Centrum Medyczne Evimed	Warszawa	Mazowieckie
Russian Federation	GBUZ Clinical dermatology and venereological dispensary	Krasnodar	Krasnodarskiy Kray
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
Spain	Hospital General Universitario Alicante	Alicante
Spain	Hospital del Mar	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona	Badalona
Spain	Hospital De Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	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
Taiwan	Chang Gung Memorial Hospital - Kaohsiung	Kaohsiung
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
Taiwan	Chang Gung Memorial Hospital - Taipei	Taipei City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan, (r.o.c.)

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1	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.; The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 16, 36 and 52
Primary	RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 16, 36, and 52
Secondary	RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 16, 36, and 52
Secondary	RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 16, 36, and 52
Secondary	Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 16, 36 and 52
Secondary	NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 16, 36, and 52
Secondary	NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 16, 36, 52
Secondary	NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 16, 36, and 52
Secondary	RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 16, 36, and 52 Weeks
Secondary	RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 16, 36, and 52
Secondary	NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 16, 36, and 52
Secondary	NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 16, 36, and 52
Secondary	RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16
Secondary	RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16
Secondary	NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16
Secondary	NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16
Secondary	NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1	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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1	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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75	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.; The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.	Weeks 4, 16, 24, 52
Secondary	NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16
Secondary	NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS	The Itch 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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.	Week 16

External Links

•   A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (Eczema) (BREEZE-AD3)