Active not recruitingPHASE2INTERVENTIONAL

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

This study is an extension of previous research into a medicine called GB002 (also known as seralutinib) for a lung condition called Pulmonary Arterial Hypertension (PAH). It's designed to see how the medicine works over a longer period. If you’ve already taken part in an earlier GB002 study for PAH, and your doctors believe you followed the study rules well, you might be able to join this one. This is an "open-label" study, which means everyone involved – both you and your medical team – will know you are receiving the active drug GB002. The goal is to gather more information about its effects and safety over time, building on what was learned in earlier phases of the research.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Enrolment target

Start

05 Apr 2021

Estimated completion

01 Dec 2027

Pulmonary Arterial Hypertension

What is this study about?

You're looking at information about a research study for a condition called Pulmonary Arterial Hypertension (PAH). PAH is a serious condition where the blood vessels in your lungs become narrowed, making it harder for your heart to pump blood through them. This study is focused on a new medicine called GB002, also known as seralutinib.

This particular study is an 'extension study.' This means it's for people who have already taken part in a previous research study looking at GB002 for PAH. The main aim is to understand the long-term effects of this medicine. Researchers want to see how it works over a longer period, including its benefits and any potential side effects when used over months or even years. This kind of long-term data is really important for understanding how a new medicine performs in the real world.

By joining an extension study, you help scientists gather more complete information about GB002. This allows them to build a full picture of the medicine's safety and how well it helps people manage their PAH over time. The results from studies like this are crucial in deciding if new treatments like GB002 can eventually become widely available to help more people with PAH.

Key takeaways

This study is for people who have already participated in a GB002 PAH study.
It aims to understand the long-term effects of the medicine GB002 for Pulmonary Arterial Hypertension.
It's an 'open-label' study, meaning everyone knows you're getting the active drug.
You will continue using an inhaler for the study medicine.
Your health will be closely monitored by medical professionals.
You can withdraw from the study at any point.

Who may be eligible?

To join this study, you first need to have already taken part in an earlier study looking at GB002 for PAH. It’s also important that your doctors believe you followed the rules of that first study carefully.

You'll need to be between 18 and 80 years old. You should also be taking your usual PAH medicines at a steady dose. Before you can join, you'll be asked to read and sign an informed consent form, which explains everything about the study in detail.

There are also some reasons why you might not be able to join. For example, if you have very high or low blood pressure that is causing problems, or if you've recently developed new heart problems on your left side. Having certain serious infections or a history of severe milk allergies could also prevent you from taking part. People who smoke or vape tobacco or marijuana, or have certain substance use disorders, might also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I previously taken part in a GB002 study for PAH?
Am I aged between 18 and 80 years old?
Am I currently on stable doses of my usual PAH medications?
Do I have any serious uncontrolled medical conditions or severe allergies, especially to milk?
Do I currently smoke or vape tobacco/marijuana, or have certain substance use disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll continue to receive the study medicine, GB002, using a generic dry powder inhaler. Because this is an extension study, the exact number of visits, tests, and how long you'll be in the study will build on your experience from the previous GB002 study you were in. The aim is to continue monitoring your health, track the effects of the medication, and identify any long-term side effects. You can expect regular check-ups, which may include physical exams, blood tests, and other assessments related to your PAH. Your medical team will explain the full schedule of visits and what each will involve, as it will be tailored to gather long-term safety and effectiveness information.

Potential risks and benefits

Taking part in this study means you'll continue to receive the promising medicine GB002, which could potentially help manage your PAH symptoms for longer. However, like all medicines, GB002 may have side effects, and these will be carefully monitored throughout the study. There's also the chance that the medicine might not work for you, or that unknown side effects could emerge over a longer period. Your health will be closely watched by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California, Davis Medical Center
Verified postcode
Sacramento, United States
Medical Corporation
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Santa Barbara, United States
Mayo Clinic
Verified postcode
Jacksonville, United States
Cleveland Clinic Florida
Verified postcode
Weston, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
Norton Pulmonary Specialists
Verified postcode
Louisville, United States
Tufts Medical Center
Verified postcode
Boston, United States
University of Nebraska Medical Center
Verified postcode
Omaha, United States
NYU Langone Health
Verified postcode
New York, United States
New York Presbyterian Hospital - Weill Cornell Medicine
Verified postcode
New York, United States
University of Rochester Medical Center
Verified postcode
Rochester, United States
The Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States

Common questions

What is 'open-label'?

Open-label means that everyone involved – you, your doctor, and the study team – will know that you are receiving the active study medicine, GB002.

Why is this study only for people who were in a previous GB002 study?

This is an 'extension' study. It builds on earlier research to understand how GB002 works over a longer time in people who have already started treatment.

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a condition where the blood vessels in your lungs become narrow, stiff, or blocked, making it harder for blood to flow through them and causing strain on your heart.

Will I stop taking my other PAH medicines?

No, you will generally continue taking your usual PAH medicines at a stable dose alongside the study medicine, GB002.

What if I decide I don't want to continue the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your regular medical care.