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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

1. EASI of 12 or more

2. Greater than or equal to 10% of body surface area involvement

3. Diagnosed with AD at least 2 years prior

• Have a history of inadequate clinical response to other eczema treatments

Exclusion Criteria:

• 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