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

Brief summary (registry, in English)

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

What you commit to

• Study type: Interventional · Phase 3
• Participants enrolled: 669
• From 11 Jan 2024 to the primary completion date, 10 Sept 2026
• 257 sites in 34 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (257)

Sites in registry order. Pick your city on the disease page to sort them by distance.