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
NCT ID: NCT03428100
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
463 participants
INTERVENTIONAL
2018-05-15
2023-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional Placebo administered orally to maintain the blind.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Substudy 2 mg Baricitinib to 1 mg Baricitinib (Responders/Partial Responders)
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Interventions
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Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have had inadequate response 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.
* Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past.
Exclusion Criteria
* A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
* Participants who are currently experiencing a skin infection that requires treatment, or are 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 less than 4 weeks prior to randomization.
* Received oral corticosteroids within 4 weeks prior to randomization or 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, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
* Have a current or recent and/or clinically serious viral, bacterial, fungal, or parasitic 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Universitätsklinikum Graz
Graz, Styria, Austria
Universitätsklinik Innsbruck
Innsbruck, Tyrol, Austria
KA Rudolfstiftung
Vienna, , Austria
AKH
Vienna, , Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna, , Austria
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven - Campus Sint-Rafaël
Leuven, , Belgium
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd
Vitória, Espírito Santo, Brazil
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, Rio de Janeiro, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro, Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento - Instituto de Educação e Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Ciências Médicas - UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clinicas da FMRP
Ribeirão Preto, São Paulo, Brazil
Fundação Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Terveystalo Tampere
Tampere, Irkanmaa, Finland
Helsinki University Central Hospital
Helsinki, , Finland
Hospital Mehiläinen Neo
Turku, , Finland
Hôpital de Pontchaillou
Rennes, Cedex 9, France
CHU de Besancon Hopital Jean Minjoz
Besançon, , France
CHU de Bordeaux Hopital Saint Andre
Bordeaux, , France
Hôpital C. HURIEZ
Lille, , France
Hôpital Emile Muller
Mulhouse, , France
Chru De Nantes Hotel-Dieu
Nantes, , France
CHU de Nice Hopital de L'Archet
Nice, , France
Hopital Sainte Anne (H.I.A)
Toulon, , France
Hopital Larrey
Toulouse, , France
Centre Hospitalier de Valence
Valence, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Hautarztpraxis Dr. Leitz und Kollegen
Stuttgart, Baden-Wurttemberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum Rechts der Isar der TU München
München, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
Buxtehude, Lower Saxony, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Klinische Forschung Osnabrück
Osnabrück, Lower Saxony, Germany
Fachklinik Bad Bentheim
Bad Bentheim, North Rhine-Westphalia, Germany
St Josef-Hospital Bochum
Bochum, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia
Milan, Milan, Italy
Ospedale Clinicizzato San Donato
San Donato Milanese, Milan, Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, Rome, Italy
Azienda Ospedaliera Umberto I
Ancona, , Italy
Spedali Civili - Universita degli Studi
Brescia, , Italy
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, , Italy
Azienda Ospedaliera di Perugia
Perugia, , Italy
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
Policlinico di Tor Vergata
Roma, , Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, , Italy
Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, Japan
Fumimori Clinic
Fukuoka, Fukuoka, Japan
Queen's Square Dermatology and Allergology
Nishi-ku, Yokohama-city, Kanagawa, Japan
Noguchi Dermatology
Kashima-machi, Kamimashiki-gun, Kumamoto, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, Japan
Sanrui Dermatology Clinic
Ohmiya-ku,Saitama-shi, Saitama, Japan
Iidabashi Clinic
Chiyoda-ku, Tokyo, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, Japan
Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, Japan
Academisch Medisch Centrum
Amsterdam, , Netherlands
Bravis Ziekenhuis
Bergen op Zoom, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, , Poland
Centrum Badan Klinicznych, PI House
Gdansk, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Barbara Rewerska DIAMOND CLINIC
Krakow, , Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
Olsztyn, , Poland
DermoDent, Centrum Medyczne Czajkowscy
Osielsko, , Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, , Poland
Centralny Szpital Kliniczny MSW Klinika Dermatologii
Warsaw, , Poland
Wojskowy Instytut Medyczny CSK MON
Warsaw, , Poland
State scientific centre for dermatovenerology and cosmetolog
Moscow, , Russia
First Moscow State Medical University n.a. Sechenov
Moscow, , Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, , Russia
LLC ArsVitae NorthWest
Saint Petersburg, , Russia
LLC Medical Center "Kurator"
Saint Petersburg, , Russia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Univ. Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital De Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario Dr Pesset
Valencia, , Spain
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Inselspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
West Glasgow Ambulatory Care Hospital
Glasgow, Lanarkshire, United Kingdom
Whipps Cross University Hospital
Leytonstone, London, United Kingdom
Broadgreen Hospital
Liverpool, Merseyside, United Kingdom
Guys/St. Thomas Hospital
London, Surrey, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis (Eczema) Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Adv
Other Identifiers
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I4V-MC-JAIN
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004574-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16841
Identifier Type: -
Identifier Source: org_study_id
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