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Atopic DermatitisPhase 3BREEZE-AD6NCT03559270

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

A Phase 3 study testing Baricitinib in people with Atopic Dermatitis, run by Eli Lilly and Company at 74 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Baricitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
74 sitesin 3 countries
Study dates
27 Jun 2018to 13 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

74 sites in 3 countries.

74 sites in 3 countries

United States53 sites

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Bellaire Dermatology

    Bellaire, Texas, 77401

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Modern Research Associates

    Dallas, Texas, 75231

  • University Dermatology

    Darien, Illinois, 60561

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania, 19341

  • Wright State Univ School of Medicine

    Fairborn, Ohio, 45324

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32256

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Olympian Clinical Research

    Largo, Florida, 33770

  • Keck School of Medicine University of Southern California

    Los Angeles, California, 90033

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056

  • Forefront Research

    Louisville, Kentucky, 40241

  • Dermatologic Surgery Specialists, PC

    Macon, Georgia, 31217

  • Advanced Clinical Research LLC

    Meridian, Idaho, 83642

  • Miami Dermatology and Laser Research

    Miami, Florida, 33173

  • University of Utah MidValley Dematology

    Murray, Utah, 84107

  • Icahn Sch of Med at Mt. Sinai

    New York, New York, 10003

  • Skin Specialists, P.C

    Omaha, Nebraska, 68144

  • Riverchase Dermatology and Cosmetic Surgery

    Pembroke Pines, Florida, 33028

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • University of California Davis-Dermatology

    Sacramento, California, 95816

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Medical Center For Clinical Research

    San Diego, California, 92108

  • University Clinical Trials, Inc.

    San Diego, California, 92123

  • Advanced Medical Research

    Sandy Springs, Georgia, 30328

  • Southern California Dermatology, Inc.

    Santa Ana, California, 92701

  • Clinical Science Institute

    Santa Monica, California, 90404

  • The South Bend Clinic Center for Research

    South Bend, Indiana, 46617

  • Central Dermatology PC

    St Louis, Missouri, 63117

  • DermResearchCenter of New York, Inc

    Stony Brook, New York, 11790

  • MultiCare Good Samaritan Hospital

    Tacoma, Washington, 98405

  • University of South Florida

    Tampa, Florida, 33612

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • Care Access Research-Walnut Creek

    Walnut Creek, California, 94598

  • GWU/Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

Canada17 sites

  • Simcoderm Medical & Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9

  • Medicor Research Inc

    Greater Sudbury, Ontario, P3A 1W8

  • Lynderm Research Inc.

    Markham, Ontario, L3P1X2

  • Innovaderm Research Inc

    Montreal, Quebec, H2X 2V1

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario, L2H 1H5

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique de Quebec Metropolitain

    Québec, Quebec, G1V 4X7

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • York Dermatology Center

    Richmond Hill, Ontario, L4C 9M7

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8W 1E6

Other trials in Canada

Puerto Rico4 sites

  • Dr. Samuel Sanchez PSC

    Caguas, PR, 00727

  • Office of Dr. Alma M. Cruz

    Carolina, PR, 00985

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

Other trials in Puerto Rico

About this study

Official title: 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).

Being tested
Baricitinib
Keywords
eczema, atopic eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally

Study groups in NCT03559270
Study groupRoleWhat they receive
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).
Receives: Drug: Baricitinib
Baricitinib 1-mg/Baricitinib 2-mgExperimentalOpen-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
Receives: Drug: Baricitinib
Baricitinib 2-mg/Baricitinib 2-mgExperimentalOpen-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
Receives: Drug: Baricitinib
Baricitinib 2-mg Open-Label AddendumExperimentalParticipants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
Receives: Drug: Baricitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 16

Secondary outcomes (3)

  1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1

    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.

    Measured: Week 16

  2. Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%

    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.

    Measured: Week 16

  3. Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)

    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.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start27 Jun 2018
  3. Primary completion14 Oct 2021
  4. Study completion13 Jun 2022

Why it stopped: Terminated due to lack of alignment during regulatory negotiations.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559270
Sponsor's protocol ID
17064
Other IDs
I4V-MC-JAIX
Acronym
BREEZE-AD6
Status last verified
Oct 2022
First submitted
6 Jun 2018
Last updated
8 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36749121

  • 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.

    PubMed 33826132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib in people with Atopic Dermatitis, run by Eli Lilly and Company at 74 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03559270, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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