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Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis — ATLANTIS  

Dermatitis Atopic Clinical Trial

Official title:
An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Clinical Trial Summary

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: - A screening period of up to 2 to 4 weeks - An open label treatment period of up to 160 weeks (approximately 3 years) - A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05769777
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Status Recruiting
Phase Phase 2
Start date April 3, 2023
Completion date October 9, 2028
View Details
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