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Study on Seralutinib for Treating Pulmonary Arterial Hypertension in Patients

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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 Pulmonary Arterial Hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. The study will evaluate the effectiveness and safety of a treatment called seralutinib, which is administered as an inhalation powder in a hard capsule. Participants will either receive seralutinib or a placebo, which looks identical to the treatment but does not contain the active substance.

The purpose of the study is to assess how seralutinib affects exercise capacity after 24 weeks of treatment when used alongside existing PAH medications. Participants will be randomly assigned to receive either seralutinib or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for a total of 48 weeks, during which participants will continue their regular PAH treatment while adding the study medication or placebo.

Throughout the study, participants will undergo various assessments to monitor their health and the effects of the treatment. These assessments will include measuring the distance they can walk in six minutes, which helps evaluate their exercise capacity. The study aims to provide valuable information on whether seralutinib can improve the quality of life for individuals with PAH by enhancing their ability to exercise and perform daily activities.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the investigational drug seralutinib or a placebo. The placebo is an inhalation powder that looks identical to the drug and is administered in the same way.

  2. Step 2

    Medication administration

    The participant will use the assigned inhalation powder, either seralutinib or placebo, through an inhaler device. The specific dosage and frequency of administration will be provided by the study team.

  3. Step 3

    Treatment duration

    The treatment will last for a period of 24 weeks. During this time, the participant will continue their background medication for pulmonary arterial hypertension (PAH) as prescribed.

  4. Step 4

    Exercise capacity evaluation

    The main objective of the study is to evaluate the effect of seralutinib on exercise capacity. This will be measured by the change in distance achieved on the six-minute walk test from the start of the study to week 24.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the participant will undergo regular assessments to monitor their health and the effects of the treatment. This includes checking for any adverse events and measuring specific health indicators.

  6. Step 6

    Study completion

    At the end of the 24-week treatment period, the participant will complete a final set of assessments to evaluate the overall impact of the treatment.

Who can join the trial?

11 criteria

  • Adults aged between 18 and 75 years can participate.
  • Participants should have a Body Mass Index (BMI) between 17 and 40. BMI is a measure of body fat based on height and weight.
  • Participants must have a diagnosis of Pulmonary Arterial Hypertension (PAH), which can be idiopathic (unknown cause), heritable (runs in families), associated with connective tissue disease, linked to certain drugs, or related to congenital heart disease.
  • Participants should be able to walk between 150 and 475 meters in a 6-minute walk test.
  • Participants should be classified as WHO Functional Class II or III, which indicates the severity of their symptoms.
  • Participants need a certain score on the REVEAL Lite 2 Risk Score or specific levels of NT-proBNP or PVR, which are measures related to heart and lung function.
  • Participants must have had a cardiac catheterization recently, which is a test to check heart and lung pressures.
  • Participants should be on stable treatment with at least one PAH-specific medication for at least 12 weeks before the study.
  • Participants need to have recent pulmonary function tests, which check how well the lungs are working.
  • Women who can have children must have a negative pregnancy test before starting the study and use effective birth control if they are sexually active.
  • Men who are sexually active with women who can have children must use a condom during the study and for 90 days after the last dose of the study medication.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Pulmonary Arterial Hypertension cannot participate. This condition affects the blood vessels in the lungs, making it hard for the heart to pump blood through them.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
  • Patients who are not taking specific medications for Pulmonary Arterial Hypertension as part of their current treatment cannot participate. These medications are important for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Seralutinib is an investigational medication being studied for its potential to help people with pulmonary arterial hypertension (PAH). It is taken through oral inhalation, which means it is breathed in through the mouth. The goal of using seralutinib in this study is to see if it can improve exercise capacity, which is how well a person can perform physical activities, after 24 weeks of treatment. This medication is being tested to see if it can provide additional benefits when used alongside other PAH-specific treatments that patients are already taking.

What is already known about the treatment

Seralutinib – Seralutinib is administered through oral inhalation and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating Pulmonary Arterial Hypertension (PAH). This medication is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for Seralutinib is to improve exercise capacity in individuals with PAH. It works by targeting specific pathways involved in the narrowing of blood vessels in the lungs, helping to reduce blood pressure in these vessels. Seralutinib is classified as a pulmonary vasodilator, aiming to improve blood flow and reduce symptoms associated with PAH.

Investigated diseases

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This disease causes the small arteries in the lungs to become narrow or blocked, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through the lungs, which can lead to heart strain and enlargement. Over time, this increased workload can weaken the heart muscle and reduce its ability to pump blood effectively. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms gradually worsening over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503614-80-00Protocol codeGB002-3101Estimated enrolment384 patientsSponsorGB002 Inc.

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