Not recruitingRare disease

Study on Inhaled Seralutinib (GB002) for Patients with Pulmonary Arterial Hypertension (PAH)

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment for Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The treatment being tested is an inhaled medication called seralutinib, which is delivered through a dry powder inhaler. The purpose of the study is to evaluate how well this medication can be tolerated by patients over an extended period.

Participants in the study will use the inhaler to take the medication regularly. The study will monitor the occurrence of any side effects and assess changes in the participants' ability to walk a certain distance in six minutes, which is a common way to measure physical endurance in people with PAH. This study is an open-label extension, meaning that all participants will receive the active medication rather than a placebo.

The study aims to provide valuable information about the long-term use of seralutinib for treating Pulmonary Arterial Hypertension. By participating, individuals who have completed a previous study with this medication can continue to receive treatment while contributing to the understanding of its safety and benefits over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, confirmation of eligibility is required. This includes a review of previous participation in a seralutinib study and compliance with its procedures.
A negative pregnancy test is necessary for women of childbearing potential before starting the treatment.
Step 2
Treatment initiation
The treatment involves the use of seralutinib, administered as an inhalation powder in hard capsules.
The medication is taken through inhalation, which means breathing it in through the mouth.
Step 3
Treatment schedule
The treatment is ongoing, with regular administration of the medication as prescribed by the study protocol.
Participants are required to adhere to the treatment plan and attend scheduled visits for monitoring.
Step 4
Monitoring and assessments
Regular assessments are conducted to monitor the safety and effectiveness of the treatment.
These assessments include tracking any side effects and measuring changes in physical activity, such as the distance walked in six minutes.
Step 5
Completion
The study is expected to continue until April 2027, with participants completing the treatment as per the study's timeline.
Upon completion, final assessments are conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

9 criteria

Adult women aged 18 to 80 years or adult men aged 50 to 80 years can participate.
Participants must have signed a document showing they understand the study and agree to take part.
Participants should be willing and able to attend scheduled visits, follow the treatment plan, and complete tests and other study procedures.
Participants must have completed a previous study with the medication seralutinib for **Pulmonary Arterial Hypertension (PAH)** and followed the study rules.
Participants should be on stable doses of standard treatments for **Pulmonary Arterial Hypertension (PAH)**.
Women who can have children must have a negative pregnancy test before starting the study medication.
Women who cannot have children must show evidence of being post-menopausal, which means they haven't had a period for 12 months without another medical reason.
Women who can have children and are sexually active with a male partner must use a highly effective method of birth control during the study and for 30 days after the last dose of the study medication.
Men who are not sterilized and are sexually active with a female partner who can have children must use a condom during the study and for 90 days after the last dose of the study medication. They should also not donate sperm during this time.

Who cannot join the trial?

9 criteria

Patients who have a different type of high blood pressure in the lungs other than Pulmonary Arterial Hypertension (PAH) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to take the study medication as an inhaled treatment cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent surgery or are planning to have surgery soon cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Universitario 12 De Octubre
Madrid, Spain
Verified
Hospital Universitario Marques De Valdecilla
Santander, Spain
Verified
Medizinische Hochschule Hannover
Hanover, Germany

Trial locations

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Investigated drugs

GB002: This medication is being studied for its long-term safety and effectiveness in treating pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the arteries in the lungs and the heart. It is administered through oral inhalation, which means it is breathed in through the mouth to reach the lungs directly. The goal of this study is to see how well patients tolerate this treatment over an extended period.

Seralutinib

What is already known about the treatment

Seralutinib – This medication is administered through oral inhalation and is currently being studied for its long-term safety and effectiveness in treating Pulmonary Arterial Hypertension (PAH). It is in the clinical trial phase, with ongoing research to establish its role in medical practice. The main therapeutic indication for seralutinib is PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, seralutinib works by inhibiting certain pathways that contribute to the narrowing of blood vessels, thereby reducing blood pressure in the lungs. It is classified pharmacologically as a kinase inhibitor, targeting specific enzymes involved in the disease process.

Investigated diseases

Pulmonary Arterial Hypertension (PAH) – This is a condition characterized by high blood pressure in the arteries that supply the lungs. It occurs when the small arteries in the lungs become narrowed or blocked, making it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through these arteries, which can lead to heart strain and enlargement. Over time, this increased pressure can cause symptoms such as shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The disease progresses as the blood vessels in the lungs continue to narrow, leading to worsening symptoms and reduced ability to exercise.