Active not recruitingPHASE3INTERVENTIONAL

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

This ongoing study, called PROSERA-EXT, is for adults with a condition called pulmonary arterial hypertension (PAH). Participants have already taken part in a previous study where they received an inhaled medication called seralutinib. This new study aims to understand the long-term safety, how well people tolerate the medicine, and how effective it is over a longer period. It's an "open-label" study, which means both you and your doctor will know you are receiving seralutinib. The study will continue until the medicine is approved for general use or the study ends. The goal is to gather more information about seralutinib to help people with PAH in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

GB002, Inc.

Enrolment target

316

Start

03 Sep 2024

Estimated completion

01 Dec 2026

Pulmonary Arterial Hypertension

What is this study about?

This study, called PROSERA-EXT, is designed for adults who have a serious lung condition known as pulmonary arterial hypertension, or PAH. PAH makes the blood vessels in the lungs narrow, which makes it harder for the heart to pump blood and get oxygen to the body. This study is an "extension" of a previous study where participants already received an inhaled medication called seralutinib.

The main purpose of this extension study is to keep a close eye on the long-term effects of seralutinib. We want to see how safe it is when taken over a longer period, how well people tolerate it (meaning if they have any side effects and how manageable they are), and how effective it is at helping manage their PAH symptoms. The study is "open-label," which means everyone involved – including the patients and doctors – knows that seralutinib is being given.

The information gathered from this study is really important. It helps researchers understand more about seralutinib before it might be made available to more people with PAH. By participating, you would be contributing valuable insights that could lead to new treatment options for this condition.

Key takeaways

This study is for adults with PAH who have already taken seralutinib in a previous study.
It aims to understand the long-term safety and effectiveness of inhaled seralutinib.
Participation involves taking the study medicine and attending regular check-ups.
You will know you are receiving seralutinib (it's an 'open-label' study).
The study continues until the medicine is approved or the study ends.
You can withdraw from the study at any time without affecting your normal medical care.

Who may be eligible?

To join this study, you must have already taken part in a previous study looking at seralutinib for PAH and completed it as planned. You also need to be willing to follow all the study instructions, attend appointments, and undergo tests.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study medicine. If you're sexually active with a male partner who hasn't had a vasectomy, you must agree to use a very effective form of birth control throughout the study and for 30 days afterwards. Men who could father a child and are sexually active with a woman who could become pregnant must use a condom for the duration of the study and for 90 days after their last dose of the study medicine.

Anyone between the ages of 18 and 75 can take part. You cannot join if you have other severe health problems or serious abnormal test results that the study doctors think might make it unsafe for you to participate or to take seralutinib.

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.

I have pulmonary arterial hypertension (PAH).
I have already completed a previous study with seralutinib.
I am between 18 and 75 years old.
I am willing and able to attend all study visits and follow instructions.
If I am a woman who could become pregnant, I am willing to use effective birth control during and shortly after the study.
If I am a man who could father a child, I am willing to use a condom during and shortly after the study.

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to take the inhaled medicine seralutinib. The study is designed to run for a longer period, either until seralutinib is approved for use by the public or until the study officially ends. This means there isn't a fixed end date for your participation right now.

You'll have scheduled visits where the study team will monitor your health, perform tests, and ask about how you're feeling and any side effects you might be having. You'll need to follow the specific instructions for taking your medication and attending all planned appointments. The exact number and frequency of visits would be explained in detail by the study team, but they are all important for gathering the necessary information about the long-term effects of the medicine.

Potential risks and benefits

Participating in this study might offer you the potential benefit of continuing to receive seralutinib, which you've already experienced in a previous study, and could potentially help manage your PAH symptoms. However, like all medications, seralutinib may have side effects, and some tests or procedures in the study might involve minor discomfort or risks. The study team will explain all known potential risks to you before you decide to join. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your medical care.

Locations (115)

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

Valley Advanced Lung Diseases Institute
Verified postcode
Fresno, United States
Department of Veterans Affairs Greater Los Angeles Healthcare System
Verified postcode
Los Angeles, United States
UC Davis Health Medical Center
Verified postcode
Sacramento, United States
Stanford Healthcare
Verified postcode
Stanford, United States
University of Florida Health
Verified postcode
Gainesville, United States
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Verified postcode
Atlanta, United States
The Emory Clinic
Verified postcode
Atlanta, United States
Northside Hospital - Atlanta
Verified postcode
Atlanta, United States
UI Health Hospital
Verified postcode
Chicago, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
Norton Pulmonary Specialists
Verified postcode
Louisville, United States

Common questions

What is pulmonary arterial hypertension (PAH)?

PAH is a serious condition where the blood vessels in the lungs become narrow, making it hard for blood to flow through. This causes high blood pressure in the arteries of the lungs.

What is an 'open-label' study?

In an 'open-label' study, both you and your doctor will know that you are receiving the study medicine, seralutinib.

How long will I be in this study?

The study is planned to continue until the medicine, seralutinib, gets approved for general use or until the study stops. There isn't a set end date right now.

What will happen if I decide to stop participating?

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

Will I have to pay to be in the study?

Typically, clinical trials cover the cost of study-related medication and visits. You should discuss any potential costs with the study team.