A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis
BREEZE-AD1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
3 other identifiers
interventional
660
10 countries
93
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2017
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedAugust 18, 2020
January 1, 2020
1 year
November 3, 2017
December 5, 2019
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)
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.
16 Weeks
Secondary Outcomes (23)
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)
16 Weeks
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
16 Weeks
Percentage of Participants Achieving EASI90
16 Weeks
Percent Change From Baseline in EASI Score
Baseline, 16 Weeks
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
16 Weeks
- +18 more secondary outcomes
Study Arms (8)
4 milligram (mg) Baricitinib
EXPERIMENTAL4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
2 mg Baricitinib
EXPERIMENTAL2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
1 mg Baricitinib
EXPERIMENTAL1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Placebo
PLACEBO COMPARATORPlacebo administered orally once daily.
4 mg Baricitinib Maximum Extended Enrollment Cohort
EXPERIMENTAL4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
2 mg Baricitinib Maximum Extended Enrollment Cohort
EXPERIMENTAL2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
1 mg Baricitinib Maximum Extended Enrollment Cohort
EXPERIMENTAL1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Placebo Maximum Extended Enrollment Cohort
PLACEBO COMPARATORPlacebo administered orally once daily.
Interventions
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (93)
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, Central Bohemia, 28401, Czechia
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34, Czechia
Fakultni Nemocnice v Motole
Prague, Hl. M. Praha, 150 06, Czechia
Nemocnice Na Bulovce
Prague, Hl. M. Praha, 180 81, Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, Moravskoslezský kraj, 741 01, Czechia
Fakultni Nemocnice Plzen
Plzen, Jizni Predmesti, Plzeň Region, 301 00, Czechia
Fakultni Nemocnice U svate Anny
Brno, South Moravian, 656 91, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, 40113, Czechia
Aarhus Universitehospital Marselisborg Centret
Aarhus, 8200, Denmark
Hopital Saint-Louis
Paris, Cedex 10, 75475, France
CHU de Bordeaux Hopital Saint Andre
Bordeaux, 33075, France
CHRU de Brest - Hôpital Morvan
Brest, 29200, France
CHU Grenoble Alpes
Grenoble Cédex 9, 38043, France
Chru De Nantes Hotel-Dieu
Nantes, 44093, France
CHU de Nice Hopital de L'Archet
Nice, 06202, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hopital Larrey
Toulouse, 31059, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Klinikum der Universität München
München, Bavaria, 80337, Germany
Gemeinschaftspraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15831, Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, 49565, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075, Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Praxis Dr. Thomas Dirschka
Wuppertal, North Rhine-Westphalia, 42287, Germany
Praxis Gerlach
Dresden, Saxony, 01097, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Otto-von-Guericke-Universität
Magdeburg, Saxony-Anhalt, 39120, Germany
Hautarztzentrum Kiel
Kiel, Schleswig-Holstein, 24103, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
ISA GmbH
Berlin, 10789, Germany
Praxis für Ganzheitliche Dermatologie im Ärztehaus
Berlin, 13055, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
King George Hospital
Vizag, Andhra Pradesh, 530002, India
Panchshil Hospital
Ahmedabad, Gujarat, 380005, India
Byramjee Jeejeebhoy Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, 560054, India
Dr. D. Y. Patil Medical College & Hospital
Navi Mumbai, Maharashtra, 400706, India
Jehangir Hospital
Pune, Maharashtra, 411001, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharshtra, 400012, India
All India Institue of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110 029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Chennai Meenakshi Multispeciality Hospital
Chennai, Tamil Nadu, 600004, India
Gandhi Hospital
Secunderabad, Telangana, 500003, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003, India
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliera - Universitaria Pisana
Pisa, 56126, Italy
Policlinico di Tor Vergata
Roma, 00133, Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, 37134, Italy
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, 272-0033, Japan
Fumimori Clinic
Fukuoka, Fukuoka, 815-0082, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Queen's Square Dermatology and Allergology
Nishi-ku, Yokohama-city, Kanagawa, 220-6208, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, 593-8324, Japan
Shimane University Hospital
Izumo, Shimane, 693-8501, Japan
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, 430-0929, Japan
Iidabashi Clinic
Chiyoda-ku, Tokyo, 102-0072, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0057, Japan
NTT Medical Center Tokyo
Shinagawa-KU, Tokyo, 141-8625, Japan
Shirasaki Clinic
Takaoka-shi, Toyama, 9330871, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Grupo Médico CAMINO S.C.
Mexico City, Mexico City, 03310, Mexico
Hospital de Jesus I.A.P.
Mexico City, Mexico City, 06090, Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morella, Michoacán, 58249, Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, 64060, Mexico
Hospital Univ. Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
JM Research S.C.
Cuernavaca, 62290, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000, Mexico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, 350020, Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow, 107076, Russia
Russian state medical-stomatological university n.a. Evdokimov
Moscow, 111398, Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, 194021, Russia
LLC ArsVitae NorthWest
Saint Petersburg, 194223, Russia
LLC Medical Center "Kurator"
Saint Petersburg, 196240, Russia
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei, 10508, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, 33305, Taiwan
Related Publications (5)
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.
PMID: 36255569DERIVEDSilverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.
PMID: 34688290DERIVEDThyssen 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.
PMID: 34275122DERIVEDKing 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.
PMID: 33826132DERIVEDReich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22.
PMID: 33222559DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 7, 2017
Study Start
November 23, 2017
Primary Completion
December 6, 2018
Study Completion
August 16, 2019
Last Updated
August 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.