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Monoclonal Antibodies
Lebrikizumab for Eczema (ADorable-1 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
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 belowSelect...
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
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 moreADorable-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
~6750
Topical corticosteroid
2018
Completed Phase 4
~1350
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
2,627 Previous Clinical Trials
3,217,503 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
416,176 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken Dupilumab in the last 8 weeks.I received a BCG vaccine or treatment less than 4 weeks ago.I haven't taken any experimental drugs recently.Your IGA score is 3 or higher during the screening and baseline.I haven't used any experimental skin treatments in the last 2 weeks.You have a skin condition with an EASI score of 16 or higher at the screening and baseline.I have been diagnosed with atopic dermatitis for the required time based on my age.At least 10% of my skin is affected by my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Lebrikizumab (Cohort 1)
- Group 2: Lebrikizumab (Cohort 2)
- Group 3: Placebo
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.
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.
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