MedTrace Logo

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

NCT04146363 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2022-11-30

Study results available
· View outcomes & findings →

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

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
2019-09-24
Primary Completion
2021-06-21
Completion
2022-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Estonia
  • France
  • Latvia
  • Lithuania
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146363 on ClinicalTrials.gov