Phase 2 N=124 Randomized Double-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT02576938 ↗

Enrolled (actual)

124

Serious AEs

2.4%

Results posted

Mar 2018

Primary outcome: Primary: Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50) — 37; 57; 61 percentage of participants — p==0.065

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Baricitinib (Drug); Placebo (Drug); Triamcinolone (Optional) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)	37; 57; 61	=0.065
SECONDARY Change From Baseline in the EASI at Week 16	-10.84; -16.44; -16.04	—
SECONDARY Percentage Change From Baseline in the EASI at Week 16	-45.87; -64.19; -64.69	—
SECONDARY Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16	-11.89; -23.87; -26.54	—
SECONDARY Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16	-0.9; -1.4; -1.3	—
SECONDARY Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16	-6.27; -6.89; -7.96	—
SECONDARY Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16	-1.72; -2.61; -2.22	—
SECONDARY Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib	18.5; 37.7	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02576938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.