A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Investigation of Safety and Tolerability of 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 safety and tolerability of an investigational medication in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe. The study involves patients who have already participated in previous clinical trials. The purpose is to gather more information about how the treatment affects the body and how long the effects last.
Participants in this study will receive the investigational medication through injections under the skin, either every two weeks or every four weeks. The study will also involve checking the body's response to the medication and watching for any side effects. Participants will have regular check-ups and phone calls to monitor their health during the study.
- Who can participate: Adults with COPD who completed a previous study with the investigational medication are eligible. They must have finished their last study visit within 3 days before joining this study. Key exclusions include recent cancer, certain infections, or severe allergic reactions during the previous study.
- Study details: Participants will receive injections of the investigational medication. They will be monitored for safety and side effects through regular visits and phone calls.
- Study Timelines and Visits: The study will last 72 weeks. The study requires 7 visits.
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