drugset / Trial / NCT06526182

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

NCT06526182

Phase 3 Active not recruiting 520 enrolled Almirall, S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-07-03
Primary completion
2027-04-25
Completion
2027-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Lebrikizumab Monoclonal antibody 250 mg Subcutaneous
Subject Lebrikizumab Monoclonal antibody 500 mg Subcutaneous

Indications