Active not recruitingPHASE3INTERVENTIONAL

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

This study is investigating the long-term safety and how well a new medicine called itepekimab is tolerated by people with Chronic Obstructive Pulmonary Disease (COPD). It aims to understand if the medicine remains safe and effective over a longer period. Participants in this study will have already taken part in a previous study of itepekimab. Researchers also want to confirm how the body handles the medicine and if the body develops a reaction to it. The study will compare itepekimab to a dummy treatment (placebo). This helps researchers understand the true effects of the medicine. It's designed to give more information about the medicine beyond the original studies.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

700

Start

11 Jan 2024

Estimated completion

01 Dec 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

This research study is designed to learn more about a new medicine called itepekimab, specifically for people who live with Chronic Obstructive Pulmonary Disease (COPD). You might have heard of COPD as a condition that makes it hard to breathe. The main goal of this study is to see if itepekimab is safe and well-tolerated when used for a longer time.

Researchers are particularly interested in checking for any long-term side effects and making sure the medicine continues to work over time. This study is a continuation for people who have already taken part in earlier studies of itepekimab. By following these participants, scientists can get a clearer picture of how the medicine affects people in the long run and understand its full benefits and potential risks.

The study also aims to learn more about how your body processes the medicine and if there's any immune response to it. Comparing itepekimab to a 'placebo' (a dummy treatment) helps make sure that any effects seen are truly due to the medicine and not just other factors. This detailed information is very important for deciding if this medicine could become a widely available treatment for COPD in the future.

Key takeaways

This study is for people who have already been in an itepekimab COPD study.
It aims to check the long-term safety and effects of itepekimab for COPD.
You would attend regular clinic visits and have phone calls over about 1.5 years.
Some participants will receive the real medicine, others a dummy treatment (placebo).
You can stop participating at any time if you change your mind.

Who may be eligible?

To be able to join this study, you must have previously taken part in one of two specific earlier studies on itepekimab for COPD (called EFC16750 or EFC16819). You would also need to have finished the treatment part of that study no more than three days before starting this new one.

There are also some reasons why you wouldn't be able to join. For example, if you developed certain serious health conditions during the previous study, such as specific types of cancer (other than some skin cancers), or serious infections like tuberculosis. Also, if you had a very serious allergic reaction to the study medicine in the previous trial, or if you had to stop the medicine early due to problems, you would not be able to participate in this long-term study.

This is just a general overview and isn't a complete list of everything that might make you suitable or unsuitable for this study. Your doctor or the study team will be able to discuss all the details with you.

Quick self-check

Did I complete a previous itepekimab COPD study (EFC16750 or EFC16819)?
Did I finish the treatment part of that study within the last 3 days?
Am I generally healthy, aside from my COPD, with no new serious illnesses?
Am I between 40 and 85 years old?
Did I not have any severe allergic reactions to the study medicine in the past?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the total time you would be involved is up to 72 weeks (about a year and a half). During this time, you would be taking the study medicine (itepekimab or placebo) for up to 52 weeks (one year).

After you finish taking the medicine, there will be a follow-up period of 20 weeks to check on your health. You would need to attend 7 visits at the study clinic and have 5 check-in calls over the phone. During your clinic visits, the study team would likely perform examinations, ask you questions about your health, and collect samples (like blood or urine) to see how you are doing and how the medicine is affecting your body. You will be told whether you are receiving the active medicine or a placebo, and how often to take it.

Potential risks and benefits

Participating in this study might offer you the benefit of continuing with a potential new treatment for your COPD, which could help manage your symptoms if the medicine is effective for you. However, as with any medicine, there's always a possibility of side effects, some of which might be serious. The study is specifically designed to understand these long-term safety aspects. You will be closely monitored by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (223)

Chandler Clinical Research Trials- Site Number : 8401034
Chandler, United States
Noble Clinical Research Site Number : 8401182
Tucson, United States
Tucson Clinical Research Institute- Site Number : 8401431
Tucson, United States
IMAX Clinical Trials- Site Number : 8401419
La Palma, United States
Antelope Valley Clinical Trials Site Number : 8401003
Lancaster, United States
Downtown L.A. Research Center- Site Number : 8401027
Los Angeles, United States
Allianz Research Institute CO Site Number : 8402061
Aurora, United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
Boulder, United States
Helix Biomedics- Site Number : 8402049
Boynton Beach, United States
Beautiful Minds Clinical Research Center Site Number : 8401201
Cutler Bay, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
DeBary, United States
Science Connections, LLC Site Number : 8402045
Doral, United States

+211 more sites — see the official record for the full list.

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that makes it hard to breathe.

What is itepekimab?

Itepekimab is a new medicine being studied to see if it can help people with COPD.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the medicine.

How long will I be in the study?

The study will last up to 72 weeks (about 1 year and 5 months), with medicine taken for up to 52 weeks.

Will I have to pay to join?

No, you should not have to pay to participate in a clinical trial. All study-related care and medicines are typically provided free of charge.