Lebrikizumab for Eczema

(ADapt Trial)

Recruiting in Palo Alto (17 mi)

+81 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 will test the safety and effectiveness of lebrikizumab in people with severe eczema who have already tried another treatment called Dupilumab. Lebrikizumab aims to reduce skin inflammation by blocking a protein that causes it.

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 with moderate-to-severe atopic dermatitis (AD) who previously used Dupilumab but stopped due to intolerance, adverse events, cost issues, or lack of efficacy. They must have had AD for over a year, an IGA score of ≥3, EASI score ≥16, and at least 10% body surface area affected. Adolescents must weigh ≥40 kg. Exclusions include HIV infection, uncontrolled asthma requiring steroids recently, liver disease like cirrhosis/hepatitis, recent use of certain AD treatments including Dupilumab.

Inclusion Criteria

I stopped using dupilumab after 4 months due to it not working well enough.

I stopped taking dupilumab because it caused side effects or I couldn't tolerate it.

I have been treated with dupilumab under certain conditions.

Exclusion Criteria

You currently have a hepatitis C virus (HCV) infection.

I frequently need oral steroids for a chronic condition.

My asthma has been severe, needing steroids or hospital stays in the last year.

Treatment Details

Interventions

• Lebrikizumab (Monoclonal Antibodies)

Trial Overview The trial is testing the safety and effectiveness of Lebrikizumab in those who've had previous treatment with Dupilumab without success or could not tolerate it. The goal is to see if Lebrikizumab can improve symptoms in patients with moderate-to-severe AD.

Participant Groups

Group I: Lebrikizumab Experimental Treatment 1 Intervention

Participants will receive Lebrikizumab by subcutaneous (SC) injection.

Lebrikizumab is already approved in Canada for the following indications:

Approved in Canada as Ebglyss for:

• Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University