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A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD — AERIFY-4  

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies

Clinical Trial Summary

This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: - The study duration will be up to 72 weeks - The treatment duration will be up to 52 weeks - A follow-up period of 20 weeks will be conducted - The number of on-site visits will be 7 and the number of phone contacts will be 5

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06208306
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email contact-us@sanofi.com
Status Recruiting
Phase Phase 3
Start date January 11, 2024
Completion date December 1, 2026
View Details
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