A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis

Last updated: August 11, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Dermatitis, Atopic

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT03435081
17049
I4V-MC-JAIW
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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
  • ≥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 topicaltreatments during a washout period).
  • Agree to use emollients daily.

Exclusion

Exclusion Criteria:

  • 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 intravenoustreatment for skin infections.
  • A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodeof 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 systemiccorticosteroids or otherwise interfere with study participation or require activefrequent 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 4weeks before randomization
  • received any parenteral corticosteroid administered by intramuscular orintravenous injection within 6 weeks of planned randomization or are anticipatedto require parenteral injection of corticosteroids during the study
  • have had an intra-articular corticosteroid injection within 6 weeks of plannedrandomization
  • probenecid at the time of randomization that cannot be discontinued for theduration of the study
  • Have high blood pressure characterized by a repeated systolic blood pressure >160millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
  • Have had major surgery within the past eight weeks or are planning major surgeryduring the study.
  • Have experienced any of the following within 12 weeks of screening: myocardialinfarction (MI), unstable ischemic heart disease, stroke, or New York HeartAssociation Stage III/IV heart failure.
  • Have a history of venous thromboembolic event (VTE), or are considered at high riskfor VTE.
  • Have a history or presence of cardiovascular, respiratory, hepatic, chronic liverdisease gastrointestinal, endocrine, hematological, neurological, lymphoproliferativedisease or neuropsychiatric disorders or any other serious and/or unstable illness.
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasiticinfection including herpes zoster, tuberculosis.
  • Have specific laboratory abnormalities.
  • Have received certain treatments that are contraindicated.
  • Pregnant or breastfeeding.

Study Design

Total Participants: 440
Study Start date:
February 20, 2018
Estimated Completion Date:
August 16, 2021

Connect with a study center

  • Institute for Skin Advancement

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Kirk Barber Research

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Stratica Medical

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Simcoderm Medical & Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P1X2
    Canada

    Site Not Available

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario L2H 1H5
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • Medicor Research Inc

    Sudbury, Ontario P3C 1X8
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • XLR8 Medical Research

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Innovaderm Research Inc

    Montreal, Quebec H2K4L5
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Montréal, H2K4L5
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique de Quebec Metropolitain

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • York Dermatology Center

    Richmond Hill, L4C 9M7
    Canada

    Site Not Available

  • Office of Dr. Samuel Sanchez PSC

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • Office of Dr. Alma M. Cruz

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Ponce School of Medicine CAIMED Center

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • GCM Medical Group PSC

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Wallace Medical Group, Inc.

    Beverly Hills, California 90211
    United States

    Site Not Available

  • California Dermatology and Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Keck School of Medicine University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California Davis-Dermatology

    Sacramento, California 95816
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • University Clinical Trials, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Southern California Dermatology

    Santa Ana, California 92701
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Care Access Research-Walnut Creek

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Research Center of CT/NY

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Univ of Connecticut

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • GWU/Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Olympian Clinical Research

    Largo, Florida 33770
    United States

    Site Not Available

  • Miami Dermatology & Laser Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Riverchase Dermatology and Cosmetic Surgery

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Dermatologic Surgery Specialists, PC

    Macon, Georgia 31217
    United States

    Site Not Available

  • Advanced Medical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Meridian Clinical Research

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Treasure Valley Dermatology

    Boise, Idaho 83713
    United States

    Site Not Available

  • Dermatology Center of Canyon County

    Nampa, Idaho 83651
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University Dermatology

    Darien, Illinois 60561
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • The South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Dermatology Specialist

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Central Dermatology PC

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Skin Specialists, P.C

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10003
    United States

    Site Not Available

  • DermResearchCenter of New York, Inc

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Wright State Univ School of Medicine

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio, Inc.

    Mason, Ohio 45040
    United States

    Site Not Available

  • OHSU Center for Health and Healing

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Clinical Partners LLC

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Dermatology & Laser Center of Charleston

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Bellaire Dermatology

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Modern Research Associates PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Acclaim Dermatology, PLLC

    Sugar Land, Texas 77497
    United States

    Site Not Available

  • University of Utah MidValley Dematology

    Murray, Utah 84107
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Virginia Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Multicare Health System

    Tacoma, Washington 98405
    United States

    Site Not Available

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