Lebrikizumab for Eczema
(ADjoin Trial)

Recruiting in Palo Alto (17 mi)

+421 other locations

Age: Any Age

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?

This trial is testing the safety and effectiveness of lebrikizumab, a medication for eczema. It targets people with moderate-to-severe atopic dermatitis, including those from previous studies and new participants. Lebrikizumab works by blocking a protein that causes inflammation and itching.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults and adolescents (12+ years, ≥40 kg) with chronic moderate-to-severe atopic dermatitis for over a year, who haven't responded well to topical treatments. Participants must not be pregnant or breastfeeding, agree to contraception if applicable, and have no recent live vaccines or use of certain drugs. Excludes those with serious reactions to lebrikizumab in past trials.

Inclusion Criteria

Participants coming from a parent study must have received treatment in a lebrikizumab study and have adequately completed the study treatments and last patient visit of the parent trial

I agree to use birth control or abstain from sex during and for 18 weeks after my treatment.

Participants for the Open-Label Extension Addendum must have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study

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Exclusion Criteria

I don't have hepatitis, HIV, cancer in the last 5 years, or certain medical conditions.

I have never taken lebrikizumab or had a severe allergic reaction.

I have not used certain immune drugs, had phototherapy, or received live vaccines recently.

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Treatment Details

Interventions

Lebrikizumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing the long-term safety and effectiveness of Lebrikizumab in treating moderate-to-severe atopic dermatitis over a period of 110 weeks. It aims to see how well it works over time and what side effects may occur with extended use.

Participant Groups

7Treatment groups

Experimental Treatment

Group I: Lebrikizumab Q8W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.

Group II: Lebrikizumab Q4W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.

Group III: Lebrikizumab Q4WExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection. Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

Group IV: Lebrikizumab Q2W (Open-Label) from Parent StudyExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.

Group V: Lebrikizumab Q2W (Open-Label Extension Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.

Group VI: Lebrikizumab Q2W (Open-Label Addendum)Experimental Treatment1 Intervention

Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.

Group VII: Lebrikizumab Q2W (Blinded) from Parent StudyExperimental Treatment1 Intervention

Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.

Lebrikizumab is already approved in Canada for the following indications: