A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03435081
Last Updated: 2022-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
440 participants
INTERVENTIONAL
2018-02-20
2021-08-16
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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2 milligram (mg) Baricitinib
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally
Placebo
Administered orally
1 mg Baricitinib
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
Baricitinib
Administered orally
Placebo
Administered orally
Placebo
Placebo administered orally every day.
Placebo
Administered orally
Interventions
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Baricitinib
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have moderate to severe AD, including all of the following:
* EASI score ≥16
* IGA score of ≥3
* ≥10% of 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 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 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 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, 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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Wallace Medical Group, Inc.
Beverly Hills, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Keck School of Medicine University of Southern California
Los Angeles, California, United States
University of California Davis-Dermatology
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Care Access Research-Walnut Creek
Walnut Creek, California, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Univ of Connecticut
Farmington, Connecticut, United States
GWU/Medical Faculty Associates
Washington D.C., District of Columbia, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Olympian Clinical Research
Largo, Florida, United States
Miami Dermatology & Laser Research
Miami, Florida, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States
University of South Florida
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Treasure Valley Dermatology
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University Dermatology
Darien, Illinois, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Dermatology Specialist
Louisville, Kentucky, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Central Dermatology PC
St Louis, Missouri, United States
Skin Specialists, P.C
Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
DermResearchCenter of New York, Inc
Stony Brook, New York, United States
Bexley Dermatology Research
Bexley, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Wright State Univ School of Medicine
Fairborn, Ohio, United States
Dermatologists of Southwest Ohio, Inc.
Mason, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Dermatology & Laser Center of Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bellaire Dermatology
Bellaire, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Acclaim Dermatology, PLLC
Sugar Land, Texas, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Multicare Health System
Tacoma, Washington, United States
Kirk Barber Research
Calgary, Alberta, Canada
Institute for Skin Advancement
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Medicor Research Inc
Greater Sudbury, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Centre de Recherche Dermatologique de Quebec Metropolitain
Québec, Quebec, Canada
York Dermatology Center
Richmond Hill, , Canada
Office of Dr. Samuel Sanchez PSC
Caguas, PR, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
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.
Simpson EL, Bissonnette R, Paller AS, King B, Silverberg JI, Reich K, Thyssen JP, Doll H, Sun L, DeLozier AM, Nunes FP, Eichenfield LF. The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21.
Rosmarin D, Casillas M, Chen S, Dawson Z, Pierce E, Zhang H, Bukhalo M, Smith S. Onset of Symptom Relief Reported in Daily Diaries of Patients With Atopic Dermatitis Treated With Baricitinib in a United States Clinical Trial (BREEZE-AD5). J Cutan Med Surg. 2022 May-Jun;26(3):262-266. doi: 10.1177/12034754211073661. Epub 2022 Jan 28.
Silverberg JI, Boguniewicz M, Waibel J, Weisman J, Strowd L, Sun L, Ding Y, Feely M, Nunes FP, Simpson EL. Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16. Dermatol Ther (Heidelb). 2022 Jan;12(1):137-148. doi: 10.1007/s13555-021-00640-7. Epub 2021 Nov 30.
Silverberg 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.
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 Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis (Eczema) (BREEZE-AD5)
Other Identifiers
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I4V-MC-JAIW
Identifier Type: OTHER
Identifier Source: secondary_id
17049
Identifier Type: -
Identifier Source: org_study_id
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