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Monoclonal Antibodies

Lebrikizumab for Atopic Dermatitis (ADorable-2 Trial)

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 52

Awards & highlights

ADorable-2 Trial Summary

This trial is studying lebrikizumab in kids 6-18yo with moderate-to-severe atopic dermatitis to see if it's safe & effective long-term.

Who is the study for?

This trial is for children and teenagers aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis. Participants must have completed a previous study (KGBI) without serious side effects related to the treatment, not be pregnant or breastfeeding, and agree to use effective contraception if applicable.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of Lebrikizumab compared to a placebo in young patients with atopic dermatitis. It aims to see how well Lebrikizumab works over an extended period and monitor any ongoing risks or benefits.See study design

What are the potential side effects?

Potential side effects of Lebrikizumab may include reactions where the medicine is injected, increased risk of infections, headaches, fatigue, and possibly other immune-related conditions. The exact side effects will be monitored throughout the trial.

ADorable-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52 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 Discontinued From Study Treatment due to Adverse Events (AEs)

Secondary outcome measures

Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)

Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI

Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI

+6 more

ADorable-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: Lebrikizumab + PlaceboExperimental Treatment2 Interventions

Lebrikizumab will be given subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lebrikizumab

2014

Completed Phase 3

~6420

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,349 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,495 Total Patients Enrolled

Media Library

Lebrikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05735483 — Phase 3

Lebrikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735483 — Phase 3

Atopic Dermatitis Research Study Groups: Lebrikizumab + Placebo

Atopic Dermatitis Clinical Trial 2023: Lebrikizumab Highlights & Side Effects. Trial Name: NCT05735483 — Phase 3

Frequently Asked Questions

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

Has the FDA sanctioned this practice?

"Our experts at Power gave this treatment a rating of 3 on the safety scale due to there being evidence based data demonstrating efficacy and multiple rounds of testing confirming its safeness."

Answered by AI

Is this clinical trial currently enrolling participants?

"Indeed, the trial is open for enrollment. Clinicaltrials.gov reveals that this research was initially posted on March 9th 2023 and has recently been updated as of June 9th 2023. Specifically, 250 individuals are sought from 94 diverse locations to take part in the study."

Answered by AI

What criteria must a patient fulfill to be eligible for this research?

"Patients aged between 6 Months and 18 Years old with atopic dermatitis will be considered for this medical study. 250 individuals are projected to join the trial in total."

Answered by AI

Are there any Canadian medical centers that are actively conducting this research?

"This trial has recruited 94 individuals so far, a sample of which include Hospital Universitario de Gran Canaria Doctor Negrín in Las Palmas, National Taiwan University Hospital - Hsinchu branch in Hsinchu City, and The Derm Institute of West Michigan at Caledonia."

Answered by AI

Is enrollment available to those of advanced age for this research endeavor?

"To participate in this medical trial, prospective patients must be between 6 months and 18 years of age. The study is further stratified into 97 trials for minors and 159 trials dedicated to the elderly population."

Answered by AI

What is the magnitude of participants in this clinical trial?

"Absolutely. According to information hosted on clinicaltrials.gov, this medical research is actively recruiting patients since its inception in March 9th 2023 and most recent update on June 9th 2023. In total, 250 persons are needed at 94 different sites for the trial to be completed successfully."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

2023. "A Study to Assess the Long-Term Safety and Efficacy 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/NCT05735483.

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