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

Lilly

Status and phase: Terminated; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03559270

I4V-MC-JAIX (Other Identifier)

17064

Details and patient eligibility

About

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

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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374 participants in 4 patient groups

Placebo/Baricitinib 2-milligram (mg)

Experimental group

Description:

Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).

Treatment:

Drug: Baricitinib

Baricitinib 1-mg/Baricitinib 2-mg

Experimental group

Description:

Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).

Treatment:

Drug: Baricitinib

Baricitinib 2-mg/Baricitinib 2-mg

Experimental group

Description:

Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).

Treatment:

Drug: Baricitinib

Baricitinib 2-mg Open-Label Addendum

Experimental group

Description:

Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.

Treatment:

Drug: Baricitinib