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NCT04146363 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)
A Phase 3 study of Atopic Dermatitis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
- 20
- Study locations
NCT04146363: Completed Phase 3 study of Atopic Dermatitis, sponsored by Eli Lilly and Company.
NCT04146363 is a Phase 3 study of Atopic Dermatitis that has completed, run by Eli Lilly and Company. The registered enrollment target is 424 participants, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04146363, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Lebrikizumab
Study Locations (20)
California
- Wallace Medical Group, Inc. - Beverly Hills
- California Dermatology & Clinical Research Institute - Encinitas
- Belle Aimee Skincare Clinic - Fountain Valley
- Dermatology Research Associates - Los Angeles
- ACRC Studies - San Diego
Florida
- St. Francis Medical Institute - Clearwater
- Community Research Foundation Inc - Miami
- ForCare Clinical Research - Tampa
Michigan
- Henry Ford Hospital - Detroit
- St Joseph Dermatology and Vein Clinic - Saint Joseph
Arkansas
- Johnson Dermatology - Fort Smith
Connecticut
- Central Connecticut Dermatology - Cromwell
Georgia
- IACT Health - VHC - Columbus
Indiana
- The Indiana Clinical Trials Center - Plainfield
Kentucky
- Skin Sciences, PLLC - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 3 |
What the finished NCT04146363 record still lists
NCT04146363 is an interventional study that assigns participants to a tested intervention. The registered 424 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04146363 names 20 study sites across 13 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04146363 about?
NCT04146363 is a clinical study titled "Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)". 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...
What is the current status of trial NCT04146363?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2019-09-24. Estimated completion is 2022-05-03.
What conditions does trial NCT04146363 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT04146363?
The interventions under investigation include: Placebo (OTHER), Lebrikizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04146363?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04146363 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04146363's enrollment target sits among peer trials
424 29th of 150 higher than 122 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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