Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis
BREEZE-AD2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Patients With Moderate to Severe Atopic Dermatitis
3 other identifiers
interventional
615
9 countries
75
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
Shorter than P25 for phase_3
75 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 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2018
CompletedResults Posted
Study results publicly available
January 22, 2020
CompletedJanuary 22, 2020
January 1, 2020
1 year
November 3, 2017
December 11, 2019
January 13, 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, 2mg and 4mg Baricitinib)
The IGA measures the investigator's global assessment of the participants 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, 1mg 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 on EASI Score
Baseline, 16 Weeks
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
16 Weeks
- +18 more secondary outcomes
Study Arms (4)
4 Milligram (mg) Baricitinib
EXPERIMENTAL4mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match
2mg Baricitinib
EXPERIMENTAL2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
1mg Baricitinib
EXPERIMENTAL1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Placebo
PLACEBO COMPARATORPlacebo administered orally once daily.
Interventions
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 (80)
CENIT Centro de Neurociencias, Investigación y Tratamiento
Caba, Buenos Aires, C1125ABD, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, C1430EGF, Argentina
Fundacion CIDEA
Buenos Aires, C1121ABE, Argentina
Instituto de Neumonología y Dermatología
Buenos Aires, C1425BEA, Argentina
Psoriahue Medicina Interdisciplinaria
Buenos Aires, C1425DKG, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
Parra Dermatología
Mendoza, 5500, Argentina
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Skin & Cancer Foundation Australia
Westmead, New South Wales, 2145, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Clinical Trials SA Pty Ltd
Adelaide, South Australia, 5073, Australia
Skin and Cancer Foundation Inc.
Carlton, Victoria, 3053, Australia
Fremantle Dermatology
Perth, Western Australia, 6160, Australia
Ordensklinikum Linz GmbH - Elisabethinen
Linz, Upper Austria, 4020, Austria
KA Rudolfstiftung
Vienna, 1030, Austria
AKH
Vienna, 1090, Austria
KH Hietzing mit neurologischem Zentrum Rosenhügel
Vienna, 1130, Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna, 1220, Austria
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Trial Pharma Kft.
Püspökladány, Hajdú-Bihar, 4150, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, 5901, Hungary
Markusovszky Korhaz
Szombathely, H-9700, Hungary
MedMare Bt
Veszprém, 8200, Hungary
Haemek Medical Center- Dermatology
Afula, 1834111, Israel
Rambam Medical Center
Haifa, 3525408, Israel
Hadassah Medical Center - Ein Karem
Jerusalem, 91220, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, 272-0143, Japan
Kurume University Hospital
Kurume, Fukuoka, 830 0011, Japan
Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825, Japan
Noguchi Dermatology
Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3101, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838, Japan
Sanrui Dermatology Clinic
Ohmiya-ku,Saitama-shi, Saitama, 330-0854, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498, Japan
Tokyo Teishin Hospital
Chiyoda-Ku, Tokyo, 102-8798, Japan
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097, Japan
Yamate Dermatological Clinic
Shinjuku, Tokyo, 169-0075, Japan
Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, 190-0023, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, 15-375, Poland
Centrum Badan Klinicznych, PI House
Gdansk, 80-546, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Barbara Rewerska DIAMOND CLINIC
Krakow, 31-209, Poland
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz, 90-265, Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn, 10-229, Poland
DermoDent, Centrum Medyczne Czajkowscy
Osielsko, 86-031, Poland
LASER CLINIC S.C. Dr Tomasz Kochanowski, Dr Andrzej Krolicki
Szczecin, 70-332, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Gachon University Gil Medical Center
Incheon, Korea, 21565, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Hospital
Seoul, 05030, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Hallym University of Medicine
Seoul, 07441, South Korea
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Universitario Alicante
Alicante, 03010, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Centro de Especialidades Mollabao
Pontevedra, 36001, Spain
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
HUG-Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Related Publications (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.
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: 34275122DERIVEDBuhl 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.
PMID: 33899152DERIVEDKing 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 27, 2017
Primary Completion
December 12, 2018
Study Completion
December 12, 2018
Last Updated
January 22, 2020
Results First Posted
January 22, 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.