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Monoclonal Antibodies

Lebrikizumab for Eczema (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.

Phase 3

Recruiting

Research 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 a diagnosis of AD for at least 12 months if participants are ≥6 years of age, and 6 months if participants are 6 months to <6 years of age as per American Academy of Dermatology criteria

Have ≥10% BSA of AD involvement at the screening and baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 16

Awards & highlights

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.

Who is the study for?

This trial is for kids aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis (eczema). They must have had eczema for a certain time and meet specific severity scores. Kids can't join if they've used experimental skin treatments recently, been in another study, or received certain vaccines or drugs too close to the start of this trial.Check my eligibility

What is being tested?

The study tests Lebrikizumab's effects on young patients with eczema compared to a placebo, alongside standard eczema creams. It aims to see how safe it is and how their bodies handle it.See study design

What are the potential side effects?

Lebrikizumab may cause reactions like inflammation, pain at the injection site, infections due to immune response changes, headaches, and possibly other symptoms not yet known.

ADorable-1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with atopic dermatitis for the required time based on my age.

Select...

At least 10% of my skin is affected by my condition.

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dermira, Inc.Industry Sponsor

16 Previous Clinical Trials

5,771 Total Patients Enrolled

Eli Lilly and CompanyLead Sponsor

2,618 Previous Clinical Trials

3,201,260 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,347 Previous Clinical Trials

405,454 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 > Atopic Dermatitis