A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis (BREEZE-AD6)

October 11, 2022 updated by: Eli Lilly and Company

A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique de Quebec Metropolitain
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research
      • Calgary, Alberta, Canada, T3E 0B2
        • Beacon Dermatology
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta Dermasurgery Centre
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research
      • Markham, Ontario, Canada, L3P1X2
        • Lynderm Research Inc.
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Allergy Research Canada Inc.
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Center
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicor Research Inc
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC
      • Carolina, Puerto Rico, 00985
        • Office of Dr. Alma M. Cruz
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, United States, 92708
        • First Oc Dermatology
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90056
        • Wallace Medical Group, Inc.
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine University of Southern California
      • Sacramento, California, United States, 95816
        • University of California Davis-Dermatology
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
      • Santa Ana, California, United States, 92701
        • Southern California Dermatology, Inc.
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Walnut Creek, California, United States, 94598
        • Care Access Research-Walnut Creek
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GWU/Medical Faculty Associates
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Solutions Through Advanced Research, Inc.
      • Largo, Florida, United States, 33770
        • Olympian Clinical Research
      • Miami, Florida, United States, 33173
        • Miami Dermatology and Laser Research
      • Pembroke Pines, Florida, United States, 33028
        • Riverchase Dermatology and Cosmetic Surgery
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research
    • Georgia
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists, PC
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Darien, Illinois, United States, 60561
        • University Dermatology
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center for Research
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Forefront Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Dermatology and Skin Cancer Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology PC
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, P.C
    • New York
      • New York, New York, United States, 10003
        • Icahn Sch of Med at Mt. Sinai
      • Stony Brook, New York, United States, 11790
        • DermResearchCenter of New York, Inc
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Fairborn, Ohio, United States, 45324
        • Wright State Univ School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, United States, 97239
        • OHSU Center for Health and Healing
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • The Pennsylvania Centre for Dermatology, LLC
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah MidValley Dematology
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Have participated in Study JAIW (NCT03435081), and meet specific completion requirements for that study, and do not meet any of the following Exclusions:

  • Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
  • Have a known hypersensitivity to baricitinib or any component of this investigational product.
  • Had investigational product permanently discontinued at any time during a previous baricitinib study, except for participants who had investigational product discontinued during originating study because of rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate).
  • Had temporary investigational product interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study.
  • Pregnant or breastfeeding

OR

• Have not participated in a Study JAIW (NCT03435081) and satisfy the following criteria:

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%- 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.

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 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo/Baricitinib 2-milligram (mg)
Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Experimental: Baricitinib 1-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Experimental: Baricitinib 2-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
Experimental: Baricitinib 2-mg Open-Label Addendum
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
Time Frame: Week 16

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1
Time Frame: Week 16

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.

The results were analyzed using 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 IGA 0/1.
Week 16
Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%
Time Frame: Week 16
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Week 16
Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)
Time Frame: Week 16
The NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2018

Primary Completion (Actual)

October 14, 2021

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17064
  • I4V-MC-JAIX (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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