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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

Must not have

Treatment with an investigational drug within 8 weeks or less than 5 half-lives, whichever is longer, prior to the baseline

Treatment with a topical investigational drug within 2 weeks prior to the baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs recently.

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I haven't used any experimental skin treatments in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~6770

Topical corticosteroid

2018