Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Sponsor
Eli Lilly and Company
Study ID
NCT03334422
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

Key Dates

Start date
Nov 27, 2017
Status verified
Jan 2020
Primary completion
Dec 12, 2018
Completion
Dec 12, 2018

Study Design

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

Arms

  • Experimental: 4 Milligram (mg) Baricitinib
    4mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match
  • Experimental: 2mg Baricitinib
    2mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
  • Experimental: 1mg Baricitinib
    1mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
  • Placebo Comparator: Placebo
    Placebo administered orally once daily.

Primary Outcome Measure

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib) [ Time Frame: 16 Weeks ]

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