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Monoclonal Antibodies
Lebrikizumab for Atopic Dermatitis (ADorable-2 Trial)
Phase 3
Waitlist Available
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 up to 5 years
Awards & highlights
Pivotal 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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lebrikizumab - Optional Extension Period (OEP)Experimental Treatment1 Intervention
During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
Group II: LebrikizumabExperimental Treatment2 Interventions
Participants will receive Lebrikizumab administered 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
~6770
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,667 Previous Clinical Trials
3,228,227 Total Patients Enrolled
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11,076 Patients Enrolled for Eczema
Study DirectorEli Lilly and Company
1,383 Previous Clinical Trials
425,891 Total Patients Enrolled
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9,447 Patients Enrolled for Eczema
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was removed or withdrew from study KGBI due to issues related to lebrikizumab or other reasons like noncompliance.You had a bad reaction to lebrikizumab during a previous study, and the doctors think it's not safe for you to take it again.If my previous study's results are unknown, any side effects are assumed to be from lebrikizumab.You had a serious health problem in a previous study related to lebrikizumab, and the doctors think it might be risky for you to continue using it.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lebrikizumab
- Group 2: Lebrikizumab - Optional Extension Period (OEP)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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