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

Lilly

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Triamcinolone (Optional); Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576938

I4V-MC-JAHG (Other Identifier)

16284

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

124 participants in 2 patient groups, including a placebo group

Baricitinib

Experimental group

Description:

Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted)

Treatment:

Drug: Baricitinib

Drug: Triamcinolone (Optional)

Placebo

Placebo Comparator group

Description:

Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted)

Treatment:

Drug: Triamcinolone (Optional)

Drug: Placebo