Study Stopped
Terminated due to lack of alignment during regulatory negotiations.
A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
BREEZE-AD6
A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
2 other identifiers
interventional
374
3 countries
74
Brief Summary
This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
Typical duration for phase_3
74 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
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2022
CompletedResults Posted
Study results publicly available
November 8, 2022
CompletedNovember 8, 2022
October 1, 2022
3.3 years
June 6, 2018
October 11, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
Week 16
Secondary Outcomes (3)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1
Week 16
Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%
Week 16
Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)
Week 16
Study Arms (4)
Placebo/Baricitinib 2-milligram (mg)
EXPERIMENTALOpen-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
Baricitinib 1-mg/Baricitinib 2-mg
EXPERIMENTALOpen-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
Baricitinib 2-mg/Baricitinib 2-mg
EXPERIMENTALOpen-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
Baricitinib 2-mg Open-Label Addendum
EXPERIMENTALParticipants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.
- Have moderate to severe AD, including all of the following:
- EASI score ≥16
- IGA score of ≥3
- %- 50% BSA involvement
- 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)
- 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 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 before randomization
- received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization
- received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- have had an intra-articular corticosteroid injection within 6 weeks of planned randomization
- probenecid at the time of randomization that cannot be discontinued for the duration of the study
- 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: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (74)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Keck School of Medicine University of Southern California
Los Angeles, California, 90033, United States
Wallace Medical Group, Inc.
Los Angeles, California, 90056, United States
University of California Davis-Dermatology
Sacramento, California, 95816, United States
Medical Center For Clinical Research
San Diego, California, 92108, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Care Access Research-Walnut Creek
Walnut Creek, California, 94598, United States
GWU/Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028, United States
University of South Florida
Tampa, Florida, 33612, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217, United States
Advanced Medical Research
Sandy Springs, Georgia, 30328, United States
Advanced Clinical Research LLC
Meridian, Idaho, 83642, United States
Northwestern University
Chicago, Illinois, 60611, United States
University Dermatology
Darien, Illinois, 60561, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617, United States
Forefront Research
Louisville, Kentucky, 40241, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, 20850, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
Skin Specialists, P.C
Omaha, Nebraska, 68144, United States
Icahn Sch of Med at Mt. Sinai
New York, New York, 10003, United States
DermResearchCenter of New York, Inc
Stony Brook, New York, 11790, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wright State Univ School of Medicine
Fairborn, Ohio, 45324, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Bellaire Dermatology
Bellaire, Texas, 77401, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
University of Utah MidValley Dematology
Murray, Utah, 84107, United States
MultiCare Good Samaritan Hospital
Tacoma, Washington, 98405, United States
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Beacon Dermatology
Calgary, Alberta, T3E 0B2, Canada
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3A 1W8, Canada
Lynderm Research Inc.
Markham, Ontario, L3P1X2, Canada
Allergy Research Canada Inc.
Niagara Falls, Ontario, L2H 1H5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research
Windsor, Ontario, N8W 1E6, Canada
Innovaderm Research Inc
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Dermatologique de Quebec Metropolitain
Québec, Quebec, G1V 4X7, Canada
Dr. Samuel Sanchez PSC
Caguas, PR, 00727, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, 00985, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Related Publications (2)
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.
PMID: 36749121DERIVEDKing 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: 33826132DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The trial was terminated before completion, due to lack of alignment during regulatory negotiations.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
June 18, 2018
Study Start
June 27, 2018
Primary Completion
October 14, 2021
Study Completion
June 13, 2022
Last Updated
November 8, 2022
Results First Posted
November 8, 2022
Record last verified: 2022-10
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.