A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT03435081
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Baricitinib — DRUGAdministered orally
- Placebo — DRUGAdministered orally
Study Details
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.
Key Dates
- Start date
- Feb 20, 2018
- Status verified
- Aug 2022
- Primary completion
- Dec 9, 2019
- Completion
- Aug 16, 2021
Study Design
- Enrollment
- 440 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 2 milligram (mg) Baricitinib2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
- Experimental: 1 mg Baricitinib1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
- Placebo Comparator: PlaceboPlacebo administered orally every day.
Primary Outcome Measure
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) [ Time Frame: Week 16 ]
Locations (60)
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University of Alabama at Birmingham· Birmingham, ALJohnson Dermatology· Fort Smith, ARWallace Medical Group, Inc.· Beverly Hills, CACalifornia Dermatology and Clinical Research Institute· Encinitas, CATien Q. Nguyen, MD inc. DBA First OC Dermatology· Fountain Valley, CACenter for Dermatology Clinical Research, Inc.· Fremont, CA
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