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

Sponsor
Eli Lilly and Company
Study ID
NCT03334396
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 23, 2017
Status verified
Jan 2020
Primary completion
Dec 6, 2018
Completion
Aug 16, 2019

Study Design

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

Arms

  • Experimental: 4 milligram (mg) Baricitinib
    4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
  • Experimental: 2 mg Baricitinib
    2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
  • Experimental: 1 mg Baricitinib
    1 mg 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.
  • Experimental: 4 mg Baricitinib Maximum Extended Enrollment Cohort
    4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
  • Experimental: 2 mg Baricitinib Maximum Extended Enrollment Cohort
    2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
  • Experimental: 1 mg Baricitinib Maximum Extended Enrollment Cohort
    1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
  • Placebo Comparator: Placebo Maximum Extended Enrollment Cohort
    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, 2 mg, or 4 mg Baricitinib) [ Time Frame: 16 Weeks ]

Related Studies