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

Condition(s) studied

Investigational drug(s) / intervention(s)

Itepekimab (SAR440340): Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Placebo: Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Study 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

Eligibility

Primary outcome measure(s)

• Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation — Baseline up to Week 72
  All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit

Trial sites (223)

+ 183 more sites — see the full list on the official registry below.