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

NCT06208306 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-05-18

No results posted yet for this 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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06208306 on ClinicalTrials.gov