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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.

Key facts

Study ID

NCT02576938

Run by

Eli Lilly and Company

People needed

124

Starts

2016-02-01

Expected to finish

2017-03-01

Last updated by the study team

2020-06-17

Who can join

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

You may qualify if…

• Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:
• EASI of 12 or more
• Greater than or equal to 10% of body surface area involvement
• Diagnosed with AD at least 2 years prior
• Have a history of inadequate clinical response to other eczema treatments

You may not qualify if…

• Females who are pregnant or nursing
• Participants who do not agree to use adequate contraception
• Are currently experiencing or have a history of:
• Skin conditions such as psoriasis or lupus erythematosus
• Skin disease that requires frequent hospitalizations or intravenous treatment
• Compromised immunity
• Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
• Currently experiencing or have a history of:
• Active or latent Tuberculosis or specific immunity disorders and infections
• Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
• Human Immunodeficiency Virus (HIV)
• Hepatitis B, Hepatitis C, or chronic liver disease
• Have received certain types of vaccinations

Where it is running

• Dermatology Research Associates — Los Angeles, California, United States
• Forward Clinical Trials, Inc — Tampa, Florida, United States
• Medical Dermatology Specialists — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Icahn School of Medicine — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Menter Dermatology Research Institute — Dallas, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Fukuoka, Japan
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Sapporo, Japan
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Takaoka-shi, Japan

Full record on ClinicalTrials.gov

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