NCT05735483

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	Lebrikizumab	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2023-03-09
• Primary completion: 2027-12-01
• Completion: 2029-04-01
• First posted: 2023-02-21
• Last updated: 2025-12-17

Locations

94 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan

Regulatory

• FDA-regulated drug study