Lebrikizumab for Atopic Dermatitis
(ADorable-2 Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Eligibility Criteria

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.

Inclusion Criteria

For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.

Exclusion 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.

+2 more

Participant Groups

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.

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.

Lebrikizumab is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Ebglyss for: