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Study on Long-term Safety of Seralutinib for Patients with Pulmonary Arterial Hypertension

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). PAH is a condition where the blood pressure in the arteries of the lungs is higher than normal, which can lead to heart problems. The treatment being tested is called seralutinib, which is taken as an inhalation powder in a hard capsule form. This means the medication is inhaled directly into the lungs to help manage the condition.

The purpose of the study is to evaluate how safe and tolerable seralutinib is for people with PAH over a long period. Participants in the study will continue using the medication and will be monitored for any side effects or changes in their condition. The study will also look at how the treatment affects the distance participants can walk in six minutes, which is a common way to measure physical ability in people with PAH.

Participants will be involved in the study for up to 52 weeks, during which they will have regular check-ups and tests to ensure their safety and to gather information about the treatment's effects. The study will help researchers understand more about the long-term use of seralutinib and its potential benefits for people living with Pulmonary Arterial Hypertension.

The research process

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

  1. Step 1

    Enrollment

    Upon joining the study, confirmation of completion of a prior seralutinib study is required.

    Women of childbearing potential must undergo a pregnancy test to ensure a negative result before starting the treatment.

    Participants must provide informed consent, acknowledging understanding of the study details.

  2. Step 2

    Treatment initiation

    The treatment involves the use of seralutinib, administered as an inhalation powder in hard capsule form.

    The medication is taken through inhalation, which is a method of breathing in the medicine.

  3. Step 3

    Treatment duration

    The study aims to evaluate the long-term safety and tolerability of seralutinib in individuals with pulmonary arterial hypertension (PAH).

    Participants are expected to adhere to the treatment plan, including scheduled visits and laboratory tests.

  4. Step 4

    Monitoring and assessments

    Regular monitoring for any treatment-emergent adverse events (TEAEs) is conducted.

    Secondary assessments include changes in the distance achieved on the six-minute walk test and changes in NT-proBNP levels, which are indicators of heart stress.

  5. Step 5

    Completion

    The study is estimated to conclude by October 31, 2028.

    Participants are required to comply with all study procedures until the end of the trial.

Who can join the trial?

7 criteria

  • Participants must have completed a previous study involving the investigational product, seralutinib, for **Pulmonary Arterial Hypertension (PAH)**.
  • **Women of childbearing potential** must have a negative pregnancy test before starting the study. This test checks for a hormone called **human chorionic gonadotropin (hCG)**, which indicates pregnancy.
  • Women who can become pregnant and are sexually active with a male partner must use a highly effective form of birth control during the study and for 30 days after the last dose of seralutinib. Acceptable methods include hormonal birth control (like pills, patches, implants, or injections), intrauterine devices, or other reliable methods. They should not donate eggs during this time.
  • **Women of nonchildbearing potential** include those who have had surgical procedures like removal of ovaries or fallopian tubes, or those who are post-menopausal. Post-menopausal means not having a period for 12 months or more after stopping hormone treatments, with certain hormone levels confirming this status.
  • **Male participants** who are sexually active with a female partner who can become pregnant must use a condom during the study and for 90 days after the last dose of seralutinib. They should not donate sperm during this time.
  • Participants must have signed a document called **informed consent**, which shows they understand the important details of the study before starting any study-related activities.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.
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Investigated drugs

Seralutinib is an investigational medication being studied for its potential to treat pulmonary arterial hypertension (PAH). It is administered through oral inhalation, which means it is breathed in through the mouth using a special device. The purpose of this study is to assess how safe and well-tolerated seralutinib is when used over a long period by people with PAH. This medication aims to help manage the symptoms of PAH and improve the quality of life for those affected by this condition.

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 – Pulmonary Arterial Hypertension (PAH) is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure is due to the narrowing or blockage of these small arteries, which makes it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through the lungs, which can lead to symptoms such as shortness of breath, fatigue, and dizziness. Over time, the increased workload can cause the heart to become enlarged and weakened. PAH can progress gradually, with symptoms worsening as the disease advances. It is considered a rare disease and can affect individuals of any age, though it is more common in young adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506334-75-00Protocol codeGB002-3102Estimated enrolment343 patientsSponsorGB002 Inc.

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