NCT06526182

A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

A Phase 3, 2-Part, Open-Label and Double-Blind, Randomised Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.

Detailed description

This study consists of two parts. Part 1 is a single-arm, open-label design, where participants will receive lebrikizumab subcutaneous (SC) injections up to Week 24. Part 2 is a randomized, double-blind design, in which participants who achieve clinical response in Part 1 will continue receiving lebrikizumab treatment across two periods: a Run-in period and a Double-blind period. Participants who do not maintain at least a 50% reduction in Eczema Area and Severity Index (EASI) from baseline during Double-Blind Period will enter an Escape Arm.

Conditions

• Dermatitis, Atopic
• Eczema

Interventions

Type	Name	Description
BIOLOGICAL	Lebrikizumab	Lebrikizumab solution for injection administered subcutaneously.
OTHER	Placebo	Lebrikizumab Matching placebo solution for injection administered subcutaneously.

Timeline

• Start date: 2024-07-03
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-07-29
• Last updated: 2025-05-21

Locations

4 sites across 1 country: Spain