← Back to Search

Monoclonal Antibodies

Lebrikizumab for Atopic Dermatitis(ADorable-1 Trial)

Q: How many research subjects are being sought for this investigation?

The trial needs 300 individuals that meet the eligibility requirements in order to go ahead. The study will be conducted by Eli Lilly and Company at Treasure Valley Medical Research (Boise, ID) and Phoenix Children's Hospital (Phoenix, AZ), among other locations.

Q: For patients that are elderly, does this program still have availability?

As noted, children must be at least 6 months old but no older than 17 to participate in this clinical trial.

Q: Who would be an eligible participant in this experiment?

This trial is enrolling 300 participants, aged 6 months to 17 years, who currently have dermatitis. In order to be eligible for the study, participants must meet the following criteria: 12 months if participants are ≥6 years of age; Have ≥10% BSA of AD involvement at the screening and baseline; Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology; 6 months if participants are 6 months to &#x3C;6 years of age; Have an EASI score ≥16 at the screening and baseline; Have an IGA score ≥3 (scale of 0 to 4

Q: Are there any documented dangers in taking Lebrikizumab (Cohort 1)?

There is some prior clinical data supporting lebrikizumab's efficacy, and multiple rounds of testing have confirmed its safety. Therefore, it received a score of 3.

Q: Where are patients being treated as part of this clinical trial?

Treasure Valley Medical Research (Boise, ID), Phoenix Children's Hospital (Phoenix, AZ), and the Medical University of <a href="https://www.withpower.com/clinical-trials/south-carolina">South Carolina</a> (Charleston, SC) are three of the 30+ locations enrolling patients for this clinical trial.

Q: Are new patients being accepted into this program at the moment?

The study, which is currently recruiting patients, was first posted on clinicaltrials.gov on October 18th, 2020. The listing was most recently updated on November 9th, 2020.

Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil

Targeting 2 different conditionsLebrikizumab +2 morePhase 3RecruitingResearch Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an EASI score ≥16 at the screening and baseline

Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, week 16

Awards & highlights

Pivotal Trial

ADorable-1 Trial Summary

This trial will test lebrikizumab, a potential new treatment for atopic dermatitis, in children aged 6 months to 18 years. The trial will measure the effect, safety and how well the body absorbs lebrikizumab.

Eligible Conditions

Atopic Dermatitis

ADorable-1 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have at least 10% of your body surface area affected by atopic dermatitis (AD) during the initial screening and baseline assessments.

ADorable-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score

Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline

Secondary outcome measures

Change from Baseline in Body Surface Area (BSA)

Change from Baseline in Children Dermatology Life Quality Index (cDLQI)

Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM)

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

ADorable-1 Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Lebrikizumab (Cohort 2)Experimental Treatment2 Interventions

Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight.

Group II: Lebrikizumab (Cohort 1)Experimental Treatment2 Interventions

Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight.

Group III: PlaceboPlacebo Group2 Interventions

Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lebrikizumab

2014

Completed Phase 3

~6420

Topical corticosteroid

2018

Completed Phase 4

~1350

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dermira, Inc.Industry Sponsor

16 Previous Clinical Trials

5,583 Total Patients Enrolled

Eli Lilly and CompanyLead Sponsor

2,564 Previous Clinical Trials

3,180,527 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,319 Previous Clinical Trials

399,081 Total Patients Enrolled

Media Library

Lebrikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05559359 — Phase 3

Atopic Dermatitis Research Study Groups: Lebrikizumab (Cohort 1), Lebrikizumab (Cohort 2), Placebo

Atopic Dermatitis Clinical Trial 2023: Lebrikizumab Highlights & Side Effects. Trial Name: NCT05559359 — Phase 3

Lebrikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559359 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are being sought for this investigation?

"The trial needs 300 individuals that meet the eligibility requirements in order to go ahead. The study will be conducted by Eli Lilly and Company at Treasure Valley Medical Research (Boise, ID) and Phoenix Children's Hospital (Phoenix, AZ), among other locations."

Answered by AI

For patients that are elderly, does this program still have availability?

"As noted, children must be at least 6 months old but no older than 17 to participate in this clinical trial."

Answered by AI

Who would be an eligible participant in this experiment?

"This trial is enrolling 300 participants, aged 6 months to 17 years, who currently have dermatitis. In order to be eligible for the study, participants must meet the following criteria: 12 months if participants are ≥6 years of age; Have ≥10% BSA of AD involvement at the screening and baseline; Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology; 6 months if participants are 6 months to <6 years of age; Have an EASI score ≥16 at the screening and baseline; Have an IGA score ≥3 (scale of 0 to 4"

Answered by AI

Are there any documented dangers in taking Lebrikizumab (Cohort 1)?

"There is some prior clinical data supporting lebrikizumab's efficacy, and multiple rounds of testing have confirmed its safety. Therefore, it received a score of 3."

Answered by AI

Where are patients being treated as part of this clinical trial?

"Treasure Valley Medical Research (Boise, ID), Phoenix Children's Hospital (Phoenix, AZ), and the Medical University of South Carolina (Charleston, SC) are three of the 30+ locations enrolling patients for this clinical trial."

Answered by AI

Are new patients being accepted into this program at the moment?

"The study, which is currently recruiting patients, was first posted on clinicaltrials.gov on October 18th, 2020. The listing was most recently updated on November 9th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

2022. "A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05559359.

All > Seborrheic Dermatitis > Michigan