Overview

This trial is active, not recruiting.

Condition atopic dermatitis
Treatments baricitinib, placebo, triamcinolone (optional)
Phase phase 2
Targets JAK, JAK1
Sponsor Eli Lilly and Company
Start date February 2016
End date March 2017
Trial size 120 participants
Trial identifier NCT02576938, 16284, I4V-MC-JAHG

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted)
baricitinib LY3009104
Administered orally
triamcinolone (optional)
Administered topically
(Placebo Comparator)
Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted)
placebo
Administered orally
triamcinolone (optional)
Administered topically

Primary Outcomes

Measure
Proportion of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
time frame: Week 16

Secondary Outcomes

Measure
Change from Baseline in the EASI Score
time frame: Baseline, Week 16
Mean Change from Baseline in the Scoring Atopic Dermatitis (SCORAD)
time frame: Baseline, Week 16
Mean Change from Baseline in the Investigator's Global Assessment (IGA)
time frame: Baseline, Week 16
Change from Baseline in the Dermatologic Life Quality Index (DLQI)
time frame: Baseline, Week 16
Change from Baseline in the Itch Numerical Rating Scale (NRS)
time frame: Baseline, Week 16
Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of Baricitinib
time frame: Predose Baseline through Post Dose Week 16

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.