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Monoclonal Antibodies

Lebrikizumab for Atopic Dermatitis(ADorable-1 Trial)

Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
Targeting 2 different conditionsLebrikizumab +2 morePhase 3RecruitingResearch Sponsored by Eli Lilly and Company

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
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 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Topical corticosteroid
Completed Phase 4

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
~105 spots leftby Jul 2024