A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis

Sponsor
Eli Lilly and Company
Study ID
NCT03733301
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • Topical corticosteroid — DRUG
    Administered as standard-of-care.
  • Placebo — DRUG
    Administered orally.

Study Details

The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.

Key Dates

Start date
Nov 16, 2018
Status verified
Sep 2019
Primary completion
Jul 29, 2019
Completion
Aug 22, 2019

Study Design

Enrollment
329 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4 Milligram (mg) Baricitinib
    4 mg Baricitinib administered orally once daily in combination with topical corticosteroids (TCS). Placebo administered orally once daily to match 2 mg Baricitinib.
  • Experimental: 2 mg Baricitinib
    2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.
  • Placebo Comparator: Placebo
    Placebo administered orally once daily in combination with TCS.

Primary Outcome Measure

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement [ Time Frame: Week 16 ]

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