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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 1645
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1027AAP
    • Centro de Investigaciones Metabólicas (CINME)
  • Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
    • Buenos Aires Skin
  • Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
    • Instituto de Neumonologia y Dermatologia
  • Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
    • Psoriahue Medicina Interdisciplinaria
  • Ciudad Autonoma Buenos Aires, Argentina, C1121ABE
    • Fundacion CIDEA
  • Mendoza, Argentina, 5500
    • Parra Dermatología
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1425DES
      • CEDIC-Centro de Investigaciones Clinicas
• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Skin & Cancer Foundation Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • South Australia
    • Adelaide, South Australia, Australia, 5073
      • Clinical Trials SA Pty Ltd
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin and Cancer Foundation Inc.
  • Western Australia
    • Perth, Western Australia, Australia, 6160
      • Fremantle Dermatology
• Austria
  • Wien, Austria, 1220
    • Sozialmed. Zentrum Ost - Donauspital
  • Wien, Austria, 1090
    • AKH
  • Wien, Austria, 1030
    • KA Rudolfstiftung
  • Wien, Austria, 1130
    • KH Hietzing mit neurologischem Zentrum Rosenhügel
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Ordensklinikum Linz GmbH - Elisabethinen
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
• Czechia
  • Hl. M. Praha
    • Praha 10, Hl. M. Praha, Czechia, 100 00
      • CLINTRIAL, s.r.o.
    • Praha 10, Hl. M. Praha, Czechia, 100 34
      • Fakultní nemocnice Královské Vinohrady
    • Praha 5, Hl. M. Praha, Czechia, 150 06
      • Fakultní nemocnice v Motole
    • Praha 8, Hl. M. Praha, Czechia, 180 81
      • Nemocnice Na Bulovce
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 656 91
      • Fakultni Nemocnice U svate Anny
  • Moravskoslezsky Kraj
    • Novy Jicin, Moravskoslezsky Kraj, Czechia, 741 01
      • Nemocnice Novy Jicin a.s.
  • Plzeňský Kraj
    • Plzen-Bory, Plzeňský Kraj, Czechia, 305 99
      • Fakultní nemocnice Plzeň
  • Středočeský Kraj
    • Kutna Hora, Středočeský Kraj, Czechia, 28401
      • Kozni ambulance Kutna Hora, s.r.o.
  • Ustecký Kraj
    • Usti nad Labem, Ustecký Kraj, Czechia, 40113
      • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
• Denmark
  • Region Hovedstaden
    • Hellerup, Region Hovedstaden, Denmark, 2900
      • Gentofte Hospital
  • Region Midtjyland
    • Aarhus, Region Midtjyland, Denmark, 8200
      • Aarhus Universitehospital Marselisborg Centret
• France
  • Bordeaux Cedex, France, 33075
    • CHU de Bordeaux Hôpital Saint André
  • Grenoble Cédex 9, France, 38043
    • CHU Grenoble Alpes
  • Nantes Cedex 1, France, 44093
    • Chru De Nantes Hotel-Dieu
  • Nice cedex 3, France, 06202
    • Chu de Nice Hopital de L'Archet
  • Pierre Benite Cedex, France, 69495
    • Centre Hospitalier Lyon Sud
  • Toulouse, France, 31059
    • Hopital Larrey
  • Cedex 10
    • Paris, Cedex 10, France, 75475
      • Hopital Saint-Louis
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik
  • Berlin, Germany, 10789
    • ISA GmbH
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 13055
    • Praxis für Ganzheitliche Dermatologie im Ärztehaus
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH
  • Baden-Württemberg
    • Freiburg im Breisgau, Baden-Württemberg, Germany, 79104
      • Universitätsklinikum Freiburg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Universitätsklinikum Heidelberg
  • Bayern
    • München, Bayern, Germany, 80337
      • Klinikum der Universität München
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Gemeinschaftspraxis Mahlow
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
    • Frankfurt am Main, Hessen, Germany, 60590
      • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
      • Universitatsmedizin Rostock
  • Niedersachsen
    • Bramsche, Niedersachsen, Germany, 49565
      • Dermatologisches Zentrum Osnabrück Nord
    • Göttingen, Niedersachsen, Germany, 37075
      • Universitatsmedizin Gottingen
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitaetsklinikum Essen
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus
    • Dresden, Sachsen, Germany, 01097
      • Praxis Gerlach
    • Leipzig, Sachsen, Germany, 04103
      • Universität Leipzig - Universitätsklinikum
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Universitätsklinikum Otto-von-Guericke-Universität
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein
• Hungary
  • Budapest, Hungary, 1135
    • UNO Medical Trials Kft.
  • Veszprem, Hungary, 8200
    • Medmare Bt
  • Bekes
    • Oroshaza, Bekes, Hungary, 5900
      • Oroshaza Varosi Onkormanyzat Korhaza
  • Csongrad
    • Szeged, Csongrad, Hungary, 6720
      • SZTE AOK Borgyogyaszati es Allergologiai Klinika
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
    • Puspokladany, Hajdu-Bihar, Hungary, 4150
      • Trial Pharma Kft.
  • Jasz-Nagykun-Szolnok
    • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
      • Allergo-Derm Bakos Kft
  • Somogy
    • Kaposvar, Somogy, Hungary, 7400
      • Kaposi Mór Oktató Kórház
  • Vas
    • Szombathely, Vas, Hungary, 9700
      • Markusovszky Korhaz
• India
  • Andhra Pradesh
    • Vizag, Andhra Pradesh, India, 530002
      • King George Hospital
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital
    • New Delhi, Delhi, India, 110 029
      • All India Institue of Medical Sciences (AIIMS)
  • Gujarat
    • Ahmedabad, Gujarat, India, 380005
      • Panchshil hospital
    • Ahmedabad, Gujarat, India, 380016
      • Byramjee Jeejeebhoy Medical College & Civil Hospital
  • Maharashtra
    • Navi Mumbai, Maharashtra, India, 400706
      • Dr. D. Y. Patil Medical College & Hospital
  • Maharshtra
    • Mumbai, Maharshtra, India, 400012
      • Seth GS Medical College & KEM Hospital
  • Telangana
    • Secunderabad, Telangana, India, 500003
      • Gandhi Hospital
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center- Dermatology
  • Haifa, Israel, 3525408
    • Rambam Medical Center
  • Jerusalem, Israel, 91220
    • Hadassah Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
• Italy
  • Genova, Italy, 16132
    • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Pisa, Italy, 56126
    • Azienda Ospedaliera - Universitaria Pisana
  • Roma, Italy, 00133
    • Policlinico di Tor Vergata
  • Verona, Italy, 37134
    • Ospedale Policlinico Giambattista Rossi, Borgo Roma
  • Vicenza, Italy, 36100
    • ULSS 8
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Policlinico Univ. Agostino Gemelli
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
• Japan
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Chiba
    • Ainokawa, Ichikawa-shi, Chiba, Japan, 272-0143
      • Yanagihara dermatology clinic
    • Ichikawa-shi, Chiba, Japan, 272-0033
      • Kawashima Dermatology Clinic
    • Matsudo-shi, Chiba, Japan, 271-0092
      • Medical Corporation Soleil Miyata Dermatology Clinic
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 815-0082
      • Fumimori Clinic
    • Kurume, Fukuoka, Japan, 830 0011
      • Kurume University Hospital
  • Hiroshima-ken
    • Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0063
      • Sapporo Skin Clinic
    • Sapporo, Hokkaido, Japan, 006 0022
      • Shibaki Dermatology Clinic
  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Tokyo Medical University Ibaraki Medical Center
  • Kanagawa
    • Nishi-ku, Yokohama-city, Kanagawa, Japan, 220-6208
      • Queen's Square Dermatology and Allergology
    • Yokohama-shi, Kanagawa, Japan, 231-8682
      • Yokohama City Minato Red Cross Hospital
    • Yokohama-shi, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic
  • Kumamoto
    • Kashima-machi, Kamimashiki-gun, Kumamoto, Japan, 861-3101
      • Noguchi Dermatology
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • Kyoto Prefectural University of Medicine
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Neyagawa-shi, Osaka, Japan, 572-0838
      • Yoshioka Dermatology Clinic
    • Nishi-ku Sakai-shi, Osaka, Japan, 593-8324
      • Kume Clinic
    • Toyonaka-shi, Osaka, Japan, 560-0085
      • Senri-Chuo Hanafusa Dermatology Clinic
  • Saitama
    • Ohmiya-ku,Saitama-shi, Saitama, Japan, 330-0854
      • Sanrui Dermatology Clinic
  • Shimane
    • Izumo, Shimane, Japan, 693-8501
      • Shimane University Hospital
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 430-0929
      • JA Shizuoka Kohseiren Enshu Hospital
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Chiyoda-Ku, Tokyo, Japan, 102-8798
      • Tokyo Teishin Hospital
    • Chiyoda-ku, Tokyo, Japan, 102-0072
      • Iidabashi Clinic
    • Chuo-ku, Tokyo, Japan, 103-0025
      • Nihonbashi Sakura Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Hosono Clinic
    • Edogawa-ku, Tokyo, Japan, 133-0057
      • Sumire Dermatology Clinic
    • Nerima-ku, Tokyo, Japan, 178-0063
      • Oizumi Hanawa Clinic
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Naoko Dermatology Clinic
    • Shinagawa-KU, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo
    • Shinjuku, Tokyo, Japan, 169-0075
      • Yamate Dermatological Clinic
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Tachikawa Dermatology Clinic
  • Toyama
    • Takaoka-shi, Toyama, Japan, 9330871
      • Shirasaki Clinic
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-8506
      • Yamanashi Prefectural Central Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06973
    • Chungang University Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul st. mary's hospital
  • Gyeonggi Do
    • Suwon, Gyeonggi Do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Goyang, Gyeonggi-do, Korea, Republic of, 10326
      • DongGuk University ilsan Hospital
  • Korea
    • Incheon, Korea, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
• Mexico
  • Cuernavaca, Mexico, 62290
    • JM Research S.C.
  • Distrito Federal, Mexico, 3100
    • RM Pharma Specialists S.A. de C.V.
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 06090
      • Hospital de Jesus I.A.P.
    • México City, Distrito Federal, Mexico, 03310
      • Grupo Medico Camino S.C.
  • Michoacan Morelia
    • Morelia, Michoacan Morelia, Mexico, CP 58249
      • Clinica De Enfermedades Cronicas y Procedimientos Especiales
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • CRI Centro Regiomontano de Investigacion S.C.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez
• Poland
  • Kujawsko-pomorskie
    • Osielsko, Kujawsko-pomorskie, Poland, 86-031
      • DermoDent, Centrum Medyczne Czajkowscy
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-265
      • Dermed Centrum Medyczne Sp. z o.o.
  • Lubelskie
    • Swidnik, Lubelskie, Poland, 21-040
      • Lubelskie Centrum Diagnostyczne
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-559
      • Barbara Rewerska Diamond Clinic
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-141
      • Wojskowy Instytut Medyczny CSK MON
    • Warszawa, Mazowieckie, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA
    • Warszawa, Mazowieckie, Poland, 01-518
      • Centrum Medyczne AMED
    • Warszawa, Mazowieckie, Poland, 02-625
      • Centrum Medyczne Evimed
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-375
      • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych, PI House
  • Slaskie
    • Katowice, Slaskie, Poland, 40-611
      • Centrum Medyczne Angelius Provita
  • Warminsko-mazurskie
    • Olsztyn, Warminsko-mazurskie, Poland, 10-229
      • Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-332
      • LASER CLINIC Specjalistyczne Gabinety Lekarskie
• Russian Federation
  • Moscow, Russian Federation, 107076
    • State scientific centre for dermatovenerology and cosmetolog
  • Moscow, Russian Federation, 111398
    • Russian state medical-stomatological university n.a. Evdokimov
  • Saint-Petersburg, Russian Federation, 194223
    • LLC ArsVitae NorthWest
  • Saint-Petersburg, Russian Federation, 196240
    • LLC Medical Center "Kurator"
  • St. Petersburg, Russian Federation, 194021
    • SPb SBHI Skin-venerologic dispensary #10
  • Krasnodarskiy Kray
    • Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
      • GBUZ Clinical dermatology and venereological dispensary
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Alicante
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Las Palmas de Gran Canaria, Spain, 35010
    • Hospital De Gran Canaria Dr. Negrin
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Pontevedra, Spain, 36001
    • Centro de Especialidades Mollabao
  • Badalona
    • Barcelona, Badalona, Spain, 08916
      • Hospital Germans Trias i Pujol
  • Madrid
    • Mostoles, Madrid, Spain, 28933
      • Hospital Universitario Rey Juan carlos
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Genève, Switzerland, 1205
    • HUG-Hôpitaux Universitaires de Genève
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV centre hospitalier universitaire vaudois
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Chang Gung Memorial Hospital - Kaohsiung
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University- Shuang Ho Hospital
  • Taichung City, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei City, Taiwan, 10048
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 10508
    • Chang Gung Memorial Hospital - Taipei
  • Taoyuan, (r.o.c.), Taiwan, 33342
    • Chang Gung Memorial Hospital - Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Responders and Partial Responders (RPR)-Placebo; Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.	Drug: Placebo; Administered orally; Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: RPR-Bari 1-milligram (mg); RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: RPR-Bari 2-mg; RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: RPR-Bari 4-mg; RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: Non-responders (NR): Bari 1 mg to 2 mg; Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Bari 1 mg to 4 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Bari 2 mg to 2 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Bari 2 mg to 4 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Bari 4 mg to 4 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Placebo to Bari 2 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.	Drug: Placebo; Administered orally; Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: NR: Placebo to Bari 4 mg; NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.	Drug: Placebo; Administered orally; Drug: Baricitinib; Administered orally; Other Names: LY3009104
Placebo Comparator: Placebo; Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.	Drug: Placebo; Administered orally
Experimental: Bari 1 mg; Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: Bari 2 mg; Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: Bari 4 mg; Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104
Experimental: Bari 2-mg Open-Label Addendum; Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.	Drug: Baricitinib; Administered orally; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Incyte Corporation
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

General Publications

• King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
• Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
• Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: eczema; atopic eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 16587; I4V-MC-JAHN (Other Identifier: Eli Lilly and Company); 2017-000873-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No