NCT06208306

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Itepekimab (SAR440340)	Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
DRUG	Placebo	Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Timeline

• Start date: 2024-01-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-01-17
• Last updated: 2025-06-12

Locations

223 sites across 32 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study