Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)

J2T-DM-KGAC -

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.

Trial Summary

Age Range
≥12 years
Conditions the trial is for
Atopic Dermatitis (Eczema)
What the trial is testing?
Lebrikizumab
Could I receive a Placebo?
Yes
Enrollment Goal
445
Trial Dates
Oct 29, 2019 - Apr 28, 2022
How long will I be in the trial?
The study will last about 66 weeks and may include up to 20 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must be an adult (18 years) or adolescent (12 to <18years) and weighing 40kg

  • Participants must have atopic dermatitis that has been present for at least one year

  • Participants must have 10% body surface area (BSA) of atopic dermatitis involvement

  • Participants must have had an inadequate response to treatment with topical medications and must not have had treatment with the medications dupilumab, tralokinumab or lebrikizumab

Participants Must Not:

  • Participant must not have used certain topical atopic dermatitis treatment within 1 week

  • Participants must not have received a vaccine within 12 weeks of starting the study

  • Participants must not have hepatitis

  • Participants must not have a history of HIV

  • Participants must not have a history of cancer within 5 years

  • Women must not be pregnant, breastfeeding or plan to become pregnant during the study

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