Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis
NCT04178967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445
Last updated 2023-05-24
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Conditions
Interventions
- BIOLOGICAL
-
Lebrikizumab
Subcutaneous injection
- OTHER
-
Placebo
Subcutaneous Injection
Sponsors & Collaborators
-
Dermira, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-29
- Primary Completion
- 2021-07-12
- Completion
- 2022-04-28
- FDA Drug
- Yes
Countries
- United States
- Bulgaria
- Canada
- Germany
- Mexico
- Singapore
- Taiwan
- Ukraine
Study Locations
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