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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT03559270

Run by

Eli Lilly and Company

People needed

374

Starts

2018-06-27

Expected to finish

2022-06-13

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johnson Dermatology — Fort Smith, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• 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
• Wallace Medical Group, Inc. — 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, Inc. — Santa Ana, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Care Access Research-Walnut Creek — Walnut Creek, California, 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 and 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
• Advanced Clinical Research LLC — Meridian, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• University Dermatology — Darien, Illinois, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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