A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Investigating Long-term Safety and Tolerability of an Investigational Medication in COPD Patients
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
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Age: 40 years - 85 years
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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.
This study investigates the long-term safety and tolerability of an investigational medication in participants with Chronic Obstructive Pulmonary Disease (COPD). The study will evaluate the safety and tolerability of two dosing schedules of the investigational medication administered subcutaneously every two weeks or every four weeks to participants who have completed previous related clinical studies.
Participants will undergo various study procedures, including safety assessments and evaluations of treatment response. The study will also involve pharmacokinetic (PK) and immunogenicity assessments, which are tests to understand how the body processes the investigational medication and whether it triggers an immune response. The study consists of two arms, meaning participants will be divided into two groups receiving different treatment schedules.
- Who can participate: Participants must have COPD and have completed the treatment period in a previous Phase 3 clinical study involving the investigational medication. They must have had their end-of-treatment visit no more than 3 days before enrolling in this study. Individuals with a recent diagnosis of malignancy, certain infections, or severe allergic reactions during the parent study are excluded.
- Study details: Participants will receive the investigational medication through subcutaneous injections. They will be monitored for safety and treatment response, with assessments including pharmacokinetic and immunogenicity tests.
- Study timelines and visits: The study will last up to 72 weeks. The study requires 7 visits.
