A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable

Last updated: April 18, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Skin Infections/disorders

Skin Wounds

Treatment

Topical corticosteroid

Baricitinib

Placebo

Clinical Study ID

NCT03428100
16841
2017-004574-34
I4V-MC-JAIN
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for atleast 12 months.

  • Have had inadequate response to existing topical (applied to the skin) medicationswithin 6 months preceding screening.

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

  • Agree to use emollients daily.

  • Have a medical contraindication to cyclosporine, or had intolerance and/orunacceptable toxicity or inadequate response to cyclosporine in the past.

Exclusion

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 intravenoustreatment for skin infections.

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

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

  • Have any serious illness that is anticipated to require the use of systemiccorticosteroids or otherwise interfere with study participation or require activefrequent 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 less than 4weeks prior to randomization.

  • Received oral corticosteroids within 4 weeks prior to randomization orparenteral corticosteroids administered by intramuscular or intravenous (IV)injection within 2 weeks prior to study entry or within 6 weeks prior toplanned randomization or are anticipated to require parenteral injection ofcorticosteroids during the study.

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

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

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

  • Have experienced any of the following within 12 weeks of screening: venousthromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heartdisease, 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 asdeemed by the investigator.

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

  • Have a current or recent and/or clinically serious viral, bacterial, fungal, orparasitic infection including but not limited to herpes zoster, tuberculosis.

  • Have specific laboratory abnormalities related to thyroid, renal and liver function,or blood cells.

  • Have received certain treatments that are contraindicated.

  • Pregnant or breastfeeding.

Study Design

Total Participants: 463
Treatment Group(s): 3
Primary Treatment: Topical corticosteroid
Phase: 3
Study Start date:
May 15, 2018
Estimated Completion Date:
April 20, 2023

Connect with a study center

  • Universitätsklinikum Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Site Not Available

  • AKH

    Wien, 1090
    Austria

    Site Not Available

  • KA Rudolfstiftung

    Wien, 1030
    Austria

    Site Not Available

  • Sozialmed. Zentrum Ost - Donauspital

    Wien, 1220
    Austria

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven - Campus Sint-Rafaël

    Leuven, 3000
    Belgium

    Site Not Available

  • Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd

    Vitoria, ES 29055 450
    Brazil

    Site Not Available

  • CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

    Rio de Janeiro, RJ 22271-100
    Brazil

    Site Not Available

  • IDERJ - Instituto de Dermatologia e Estética do Brasil

    Rio de Janeiro, RJ 22470-220
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

    Porto Alegre, Rio Grande Do Sul 90560-030
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Hospital das Clinicas da FMRP

    Ribeirao Preto, SP 14048-900
    Brazil

    Site Not Available

  • Faculdade de Ciências Médicas - UNICAMP

    Campinas, Sao Paulo 13083-887
    Brazil

    Site Not Available

  • Fundação Faculdade de Medicina do ABC

    Santo André, Sao Paulo 09060-650
    Brazil

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Ribeirão Preto, 14048-900
    Brazil

    Site Not Available

  • Hospital da Clinicas da Faculdade de Medicina da USP

    Sao Paulo, 05403-000
    Brazil

    Site Not Available

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    São Paulo, 09060-650
    Brazil

    Site Not Available

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    Vitória, 29055 450
    Brazil

    Site Not Available

  • Terveystalo Tampere

    Tampere, Irkanmaa 33100
    Finland

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, 00250
    Finland

    Site Not Available

  • Hospital Mehiläinen Neo

    Turku, 20520
    Finland

    Site Not Available

  • Hôpital de Pontchaillou

    Rennes, Cedex 9 35033
    France

    Site Not Available

  • CHU de Besancon Hopital Jean Minjoz

    Besancon Cedex, 25030
    France

    Site Not Available

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    Besançon, 25030
    France

    Site Not Available

  • CHU de Bordeaux Hopital Saint Andre

    Bordeaux Cedex, 33075
    France

    Site Not Available

  • CHRU de Brest - Hôpital Morvan

    Brest, 29609
    France

    Site Not Available

  • Hôpital C. HURIEZ

    Lille, 59037
    France

    Site Not Available

  • Hôpital Emile Muller

    Mulhouse, 68100
    France

    Site Not Available

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    Nantes, 44093
    France

    Site Not Available

  • Chru De Nantes Hotel-Dieu

    Nantes Cedex 1, 44093
    France

    Site Not Available

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    Nice, 06202
    France

    Site Not Available

  • CHU de Nice Hopital de L'Archet

    Nice cedex 3, 06202
    France

    Site Not Available

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    Toulon, 83800
    France

    Site Not Available

  • Hopital Sainte Anne (H.I.A)

    Toulon Cedex 9, 83800
    France

    Site Not Available

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    Toulouse, 31059
    France

    Site Not Available

  • Hopital Larrey

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Centre Hospitalier de Valence

    Valence, 26953
    France

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Leitz und Kollegen

    Stuttgart, Baden-Württemberg 70178
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Klinikum Rechts der Isar der TU München

    München, Bayern 80802
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

    Buxtehude, Niedersachsen 21614
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Niedersachsen 30449
    Germany

    Site Not Available

  • Klinische Forschung Osnabrück

    Osnabrück, Niedersachsen 49074
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, Nordrhein-Westfalen 48455
    Germany

    Site Not Available

  • St Josef-Hospital Bochum

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • Praxis Rotterdam

    Gelsenkirchen, Nordrhein-Westfalen 45883
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, Thüringen 07743
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Hessen, 60590
    Germany

    Site Not Available

  • Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia

    Milano, Milan 20122
    Italy

    Site Not Available

  • Ospedale Clinicizzato San Donato

    San Donato Milanese, Milan 20097
    Italy

    Site Not Available

  • Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

    Roma, Rome 00161
    Italy

    Site Not Available

  • Azienda Ospedaliera Umberto I

    Ancona, 60020
    Italy

    Site Not Available

  • Spedali Civili - Universita degli Studi

    Brescia, 25123
    Italy

    Site Not Available

  • Fondazione Universitaria degli Studi G D'Annunzio

    Chieti, 66100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia

    Perugia, 06129
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Policlinico di Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Ospedale Policlinico Giambattista Rossi, Borgo Roma

    Verona, 37134
    Italy

    Site Not Available

  • Yanagihara dermatology clinic

    Ainokawa, Ichikawa-shi, Chiba 272-0143
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Ichikawa, Chiba 272-0143
    Japan

    Site Not Available

  • Fumimori Clinic

    Fukuoka-shi, Fukuoka 815-0082
    Japan

    Site Not Available

  • Queen's Square Dermatology and Allergology

    Nishi-ku, Yokohama-city, Kanagawa 220-6208
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Yokohama, Kanagawa 220-6208
    Japan

    Site Not Available

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    Kamimachi, Kumamoto 861-3101
    Japan

    Site Not Available

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    Kashima, Kumamoto 861-3101
    Japan

    Site Not Available

  • Noguchi Dermatology

    Kashima-machi, Kamimashiki-gun, Kumamoto 861-3101
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Neyagawa, Osaka 572-0838
    Japan

    Site Not Available

  • Yoshioka Dermatology Clinic

    Neyagawa-shi, Osaka 572-0838
    Japan

    Site Not Available

  • Kume Clinic

    Nishi-ku Sakai-shi, Osaka 593-8324
    Japan

    Site Not Available

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    Sakai, Osaka 593-8324
    Japan

    Site Not Available

  • Sanrui Dermatology Clinic

    Ohmiya-ku,Saitama-shi, Saitama 330-0854
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Ōmiya, Saitama 330-0854
    Japan

    Site Not Available

  • Iidabashi Clinic

    Chiyoda-ku, Tokyo 102-0072
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Edogawa, Tokyo 133-0057
    Japan

    Site Not Available

  • Sumire Dermatology Clinic

    Edogawa-ku, Tokyo 133-0057
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Tachikawa, Tokyo 190-0023
    Japan

    Site Not Available

  • Tachikawa Dermatology Clinic

    Tachikawa-shi, Tokyo 190-0023
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Chuo Ku, 103-0025
    Japan

    Site Not Available

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    Fukuoka, 815-0082
    Japan

    Site Not Available

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    Kanagawa, 220-6208
    Japan

    Site Not Available

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    Kumamoto, 861-3101
    Japan

    Site Not Available

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    Osaka, 593-8324
    Japan

    Site Not Available

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    Saitama, 330-0854
    Japan

    Site Not Available

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    Setagaya-Ku, 158-0097
    Japan

    Site Not Available

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    Tokyo, 133-0057
    Japan

    Site Not Available

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Bravis Ziekenhuis

    Bergen op Zoom, 4624 VT
    Netherlands

    Site Not Available

  • Amphia Ziekenhuis

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

    Bialystok, 15-375
    Poland

    Site Not Available

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    Białystok, 15-017
    Poland

    Site Not Available

  • Centrum Badan Klinicznych, PI House

    Gdansk, 80-546
    Poland

    Site Not Available

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    Gdańsk, 80-546
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Barbara Rewerska DIAMOND CLINIC

    Krakow, 31-559
    Poland

    Site Not Available

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    Kraków, 31-209
    Poland

    Site Not Available

  • Dermed Centrum Medyczne Sp. z o.o.

    Lodz, 90-265
    Poland

    Site Not Available

  • Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

    Olsztyn, 10-229
    Poland

    Site Not Available

  • DermoDent, Centrum Medyczne Czajkowscy

    Osielsko, 86-031
    Poland

    Site Not Available

  • LASER CLINIC Specjalistyczne Gabinety Lekarskie

    Szczecin, 70-332
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny CSK MON

    Warsaw, 04-141
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW Klinika Dermatologii

    Warszawa, 02-507
    Poland

    Site Not Available

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    Łódź, 90-265
    Poland

    Site Not Available

  • First Moscow State Medical University n.a. Sechenov

    Moscow, 119991
    Russian Federation

    Site Not Available

  • State scientific centre for dermatovenerology and cosmetolog

    Moscow, 107076
    Russian Federation

    Site Not Available

  • LLC ArsVitae NorthWest

    Saint Petersburg, 194223
    Russian Federation

    Site Not Available

  • LLC ArsVitae NorthWest

    Saint-Petersburg, 194223
    Russian Federation

    Site Not Available

  • LLC Medical Center "Kurator"

    Saint-Petersburg, 196240
    Russian Federation

    Site Not Available

  • SPb SBHI Skin-venerologic dispensary #10

    St. Petersburg, 194021
    Russian Federation

    Site Not Available

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Univ. Puerta de Hierro

    Majadahonda, Madrid 28220
    Spain

    Site Not Available

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid 28850
    Spain

    Site Not Available

  • Hospital de Manises

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Hospital De Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

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    Barcelona, 08907
    Spain

    Site Not Available

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    Madrid, 28220
    Spain

    Site Not Available

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    Torres De Segre, 28850
    Spain

    Site Not Available

  • Hospital Universitario Dr Pesset

    Valencia, 46017
    Spain

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

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    Geneva, 1211
    Switzerland

    Site Not Available

  • HUG-Hôpitaux Universitaires de Genève

    Genève, 1211
    Switzerland

    Site Not Available

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    Saint Gallen, 9007
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester M6 8HD
    United Kingdom

    Site Not Available

  • West Glasgow Ambulatory Care Hospital

    Glasgow, Lanarkshire G3 8SJ
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital

    Leytonstone, London E11 1NR
    United Kingdom

    Site Not Available

  • Broadgreen Hospital

    Liverpool, Merseyside L14 3LB
    United Kingdom

    Site Not Available

  • Guys/St. Thomas Hospital

    London, Surrey SE1 9RT
    United Kingdom

    Site Not Available

  • The Dudley Group NHS Foundation Trust

    Dudley, West Midlands DY1 2HQ
    United Kingdom

    Site Not Available

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