Lebrikizumab for Eczema

(ADtouch Trial)

Recruiting at 81 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis. This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

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

This trial is for adults and teens with chronic atopic hand or foot dermatitis lasting over a year, who haven't responded well to steroid creams. Participants must have moderate-to-severe symptoms in at least two of their hands or feet and experience significant itching.

Inclusion Criteria

* Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4.

My hand-foot skin reaction is severe or very severe.

I weigh at least 40 kg.

Treatment Details

Interventions

• Lebrikizumab (Monoclonal Antibodies)

Trial Overview The study tests Lebrikizumab's effectiveness against a placebo in improving skin lesions caused by severe eczema on the hands and feet. It includes a screening phase, treatment for 16 weeks, and follows up after 12 weeks post-treatment.

Participant Groups

Group I: Lebrikizumab Experimental Treatment 1 Intervention

Lebrikizumab administered subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Placebo Administered SC.

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