A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03733301
Last Updated: 2020-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
329 participants
INTERVENTIONAL
2018-11-16
2019-08-22
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 Milligram (mg) Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids (TCS). Placebo administered orally once daily to match 2 mg Baricitinib.
Baricitinib
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Placebo
Administered orally.
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.
Baricitinib
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Placebo
Administered orally.
Placebo
Placebo administered orally once daily in combination with TCS.
Topical corticosteroid
Administered as standard-of-care.
Placebo
Administered orally.
Interventions
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Baricitinib
Administered orally.
Topical corticosteroid
Administered as standard-of-care.
Placebo
Administered orally.
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.
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 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 less than 4 weeks prior to randomization.
* Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection 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 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.
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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Centro de Investigaciones Metabólicas (CINME) - Comite
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, , Argentina
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Skin & Cancer Foundation Australia
Westmead, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Clinical Trials SA Pty Ltd
Adelaide, South Australia, Australia
Skin and Cancer Foundation Inc.
Melbourne, Victoria, Australia
Fremantle Dermatology
Perth, Western Australia, Australia
Universitätsklinikum Graz
Graz, Styria, Austria
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Klinikum der Universität München
München, Bavaria, Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, Germany
Universitätsklinikum Aachen - UKA
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Policlinico Univ. Agostino Gemelli
Rome, Lazio, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Genova, , Italy
Azienda Ospedaliera - Universitaria Pisana
Pisa, , Italy
ULSS 8 UOC Dermatologia Viale Rodolfi, 37
Vicenza, , Italy
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, Japan
Medical Corporation Soleil Miyata Dermatology Clinic
Matsudo-shi, Chiba, Japan
Yamano Dermatological Clinic
Dazaifu, Fukuoka, Japan
Tashiro Dermatological Clinic
Iizuka, Fukuoka, Japan
Shibaki Dermatology Clinic
Sapporo, Hokkaido, Japan
Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Queen's Square Dermatology and Allergology
Nishi-ku, Yokohama-city, Kanagawa, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
Senri-Chuo Hanafusa Dermatology Clinic
Toyonaka-shi, Osaka, Japan
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, Japan
Iidabashi Clinic
Chiyoda-ku, Tokyo, Japan
Tokyo Teishin Hospital
Chiyoda-Ku, Tokyo, Japan
Hosono Clinic
Chuo-ku, Tokyo, Japan
Oizumi Hanawa Clinic
Nerima-ku, Tokyo, Japan
Yamate Dermatological Clinic
Shinjuku, Tokyo, Japan
Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, Japan
Shirasaki Clinic
Takaoka-shi, Toyama, Japan
Dermed Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Centrum Medyczne Evimed
Warsaw, , Poland
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, Korea, South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Chungang University Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Hospital del Mar
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.), , Taiwan
Countries
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References
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Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.
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.
Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.
Buhl T, Rosmarin D, Serra-Baldrich E, Fernandez-Penas P, Igarashi A, Konstantinou MP, Chen S, Lu N, Pierce E, Casillas M. Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies. Dermatol Ther (Heidelb). 2021 Jun;11(3):971-982. doi: 10.1007/s13555-021-00534-8. Epub 2021 Apr 25.
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.
Reich K, Kabashima K, Peris K, Silverberg JI, Eichenfield LF, Bieber T, Kaszuba A, Kolodsick J, Yang FE, Gamalo M, Brinker DR, DeLozier AM, Janes JM, Nunes FP, Thyssen JP, Simpson EL. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1333-1343. doi: 10.1001/jamadermatol.2020.3260.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis
Other Identifiers
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I4V-MC-JAIY
Identifier Type: OTHER
Identifier Source: secondary_id
2018-001726-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17100
Identifier Type: -
Identifier Source: org_study_id
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