RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This research study is looking into the long-term safety of a medicine called astegolimab. It's for people who have long-term obstructive pulmonary disease (COPD), a condition that makes breathing difficult. Participants for this study are those who have already completed a 52-week treatment period in two earlier studies (known as GB43311 or GB44332). The main goal is to understand if astegolimab is safe to use over a longer period, and researchers will also be checking if it helps with COPD symptoms. This study is an important step in learning more about how astegolimab might help people with COPD in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

2,000

Start

28 Jun 2023

Estimated completion

01 Jul 2034

Chronic Obstructive Pulmonary Disease

What is this study about?

This study is designed to learn more about a new medicine called astegolimab for people living with a lung condition known as chronic obstructive pulmonary disease, or COPD. COPD can make it hard to breathe, leading to symptoms like shortness of breath and coughing. Researchers want to understand if astegolimab is safe to use over a longer period of time, especially since participants have already been taking it in previous studies.

This particular study is like a follow-on for people who have already completed a full year of treatment in two earlier studies, called GB43311 or GB44332. By continuing to follow these participants, the researchers can gather important information about the long-term effects of astegolimab. This kind of information is crucial for health authorities to decide if new medicines are safe and effective enough to be made widely available.

Ultimately, the goal of this research is to help improve treatments for people with COPD. By carefully studying astegolimab, scientists hope to find better ways to help people breathe more easily and improve their quality of life. Your participation, if you're eligible, plays a vital role in advancing this understanding.

Key takeaways

This study is examining the long-term safety of astegolimab for COPD.
It's for people who have already been in earlier astegolimab studies.
Participants must have completed the full 52-week treatment in the previous studies.
The study aims to understand how the medicine works over an extended period.
You must be aged 40-90 years old to be considered.

Who may be eligible?

This study is specifically for people who have already taken part in one of two earlier research studies concerning astegolimab for COPD. You must have completed the entire 52-week treatment period in either study GB43311 or GB44332 to be considered.

There are also a few reasons why you might not be able to join. For example, if you decided to stop participating in the previous study early, or if you had to stop taking the study medication permanently, then this study might not be suitable for you. Also, if your doctor felt you didn't follow the instructions well in the earlier study, or if you've developed new health problems like a new diagnosis of asthma, another serious lung condition, or unstable heart disease, you wouldn't be able to join.

To be eligible, you need to be between 40 and 90 years old. Both men and women can take part, as long as they meet all the other requirements.

Quick self-check

Did I complete the full 52-week treatment in study GB43311 or GB44332?
Did I _not_ withdraw early from the parent study?
Have I _not_ had to stop taking the study drug permanently in the parent study?
Have I _not_ been diagnosed with new asthma or a serious new lung condition since joining the parent study?
Have I _not_ developed new unstable heart problems since joining the parent study?
Am I between 40 and 90 years old?

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, you will continue to receive the study medication, astegolimab. The study will involve regular visits to the clinic so the research team can monitor your health and see how you are responding to the treatment. These visits will likely include checking your breathing, taking blood samples, and answering questions about how you are feeling.

The duration of your participation will depend on the study design, but generally, long-term safety studies involve multiple follow-up appointments over an extended period. The research team will explain the exact schedule of visits and what each visit will involve. They will also let you know how long they expect you to be in the study in total.

Potential risks and benefits

Participating in this study might offer you continued access to a potential new treatment for COPD. The study will carefully monitor your health, which could lead to early detection of any new health issues. However, like all medicines, astegolimab may have side effects, and some may not be known yet. The research team will explain all known or potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (486)

UAB Lung Health Center
Birmingham, United States· Recruiting
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, United States· Recruiting
Jasper Summit Research LLC
Jasper, United States· Recruiting
Pulmonary Associates of Mobile PC
Mobile, United States· Recruiting
Pulmonary Associates Deer Valley Office
Phoenix, United States· Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, United States· Recruiting
Kern Allergy and Medical Research
Bakersfield, United States· Recruiting
Cadena Care Institute, LLC
Poway, United States· Recruiting
Apex Clinical Research
San Diego, United States· Completed
St Francis Medical Institute ClinEdge PPDS
Clearwater, United States· Recruiting
Finlay Medical Research Corporation
Greenacres City, United States· Recruiting
Flourish Research - Leesburg - PPDS
Leesburg, United States· Recruiting

+474 more sites — see the official record for the full list.

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, such as shortness of breath and coughing.

What is astegolimab?

Astegolimab is the name of the new medicine being tested in this study. It's hoped that it might help people with COPD, but researchers are still learning about how well it works and its long-term safety.

Why is this study only for people who were in other studies?

This study is a continuation for previous participants to see how astegolimab affects them over a longer time. This helps researchers gather important information about its long-term safety and effects.

Will I always know if I'm getting the active drug?

In some studies, participants might not know if they are getting the actual drug or a dummy treatment (placebo). However, if you've completed a prior study, the research team will explain your treatment status clearly for this long-term study.

Can I stop participating if I want to?

Yes, taking part in a study is always voluntary. You can choose to leave the study at any time, and you don't need to give a reason. This will not affect your future medical care.

How to find out more

Reference Study ID Number: GB43374 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.