Clinical Trials

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

    Investigator: Lisa Kopas

    Study Coordinator: Brooke Shope

    Status: Enrolling

    ClinicalTrials.gov Number: NCT06208306

    Phone: 713.441.3248

    Protocol Number: PRO00038590

    Description


    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