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

Investigation of Safety and Tolerability of an Investigational Medication in Chronic Obstructive Pulmonary Disease (COPD) Patients

Recruiting
40 years - 85 years
All
Phase 3
700 participants needed
36 Locations

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Pulmonary Disease
  • Age: 40 years - 85 years
  • Gender: All

Inclusion Criteria:

  • Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Exclusion Criteria:

  • Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
  • Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
  • Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
  • Any situation that led to a permanent premature IMP discontinuation in parent trials

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 18 Jun 2024. Study ID: NCT06208306

This study investigates the safety and tolerability of an investigational medication given by injection every two or four weeks in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study aims to gather more information on how safe the treatment is and how well it works over time.

Participants will receive the investigational medication through injections. Some participants will receive it every two weeks, while others will receive it every four weeks. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure the results are unbiased.

  • Who can participate: Adults aged 18 and older with COPD who completed a previous Phase 3 study involving the investigational medication are eligible. Participants must have completed the treatment period of the earlier studies and must not have had certain infections or allergic reactions during those studies.
  • Study details: Participants will receive injections of the investigational medication every two or four weeks.
  • Study Timelines and Visits: The study will last 72 weeks. The study requires 7 visits.

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