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Study on the Effectiveness and Safety of Ralinepag for Patients with Pulmonary Arterial Hypertension

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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 a condition known as pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study is evaluating a treatment called Ralinepag, which is taken as a prolonged-release tablet. This means the medication is designed to release slowly into the body over time. The purpose of the study is to understand how effective and safe Ralinepag is in improving treatment outcomes for patients with PAH.

Participants in the study will be randomly assigned to receive either Ralinepag or a placebo, which looks like the medication but does not contain the active substance. The study will monitor the time it takes for participants to experience a worsening of their condition, as defined by the study's guidelines. This will help researchers determine the effectiveness of Ralinepag in delaying the progression of PAH. The study will also look at other factors, such as changes in exercise capacity and overall health status, to gather comprehensive data on the treatment's impact.

The study will last for a period of up to 48 weeks, during which participants will have regular check-ups and assessments to track their health and any changes in their condition. This will include various tests and evaluations to ensure the safety and effectiveness of the treatment. The information gathered from this study will contribute to a better understanding of how Ralinepag can be used to manage PAH and improve the quality of life for those affected by this condition.

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 informed about all relevant aspects of the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

    The participant must provide a signed and dated informed consent form before any study-related procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of pulmonary arterial hypertension (PAH) and ensuring the participant meets all inclusion criteria.

    A right heart catheterization (RHC) may be performed if not done within the last three years to confirm the PAH diagnosis.

  3. Step 3

    Randomization and treatment

    Participants will be randomly assigned to receive either ralinepag or a placebo. Ralinepag is administered as a prolonged-release tablet taken orally.

    The dosage and frequency of administration will be determined by the study protocol and communicated to the participant.

  4. Step 4

    Regular follow-up visits

    Participants will attend scheduled follow-up visits to monitor their health and response to the treatment. These visits will include physical examinations, laboratory tests, and assessments of PAH symptoms.

    Participants are expected to comply with the treatment plan and attend all scheduled visits.

  5. Step 5

    Monitoring and data collection

    Throughout the study, data will be collected on the participant's health status, including any clinical worsening events, hospitalizations, and overall treatment outcomes.

    Participants may be asked to complete questionnaires or undergo additional tests to assess their quality of life and functional status.

  6. Step 6

    End of study

    The study will conclude on the estimated end date, or earlier if necessary. Participants will have a final visit to assess their health and discuss any further steps.

    A follow-up visit may be scheduled 30 days after the last dose of the study medication to ensure the participant's well-being.

Who can join the trial?

10 criteria

  • Must be at least 18 years old.
  • Both men and women must agree to use a **highly effective method of birth control** during the study and for a period after the study ends, if they can have children. They must also agree not to try to become pregnant or father a child during the study and for a certain time after the last dose of the study medication. Men must also agree not to donate sperm for a period after the last dose.
  • Must have signed an **Informed Consent Form**, which means they understand the important details of the study before any study-related activities begin.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.
  • Must have a primary diagnosis of **symptomatic pulmonary arterial hypertension (PAH)**, which is a type of high blood pressure affecting the lungs and heart. This can be due to various causes, such as being idiopathic (unknown cause), inherited, or caused by drugs, toxins, or other conditions like connective tissue disease or HIV infection.
  • Must have had a **right heart catheterization (RHC)**, a test to check the pressure in the heart and lungs, within the last 3 years or be willing to have one during the study screening. The results must confirm the diagnosis of PAH.
  • Must have symptoms classified as **WHO/NYHA functional class II to IV**, which describes the severity of symptoms and how they affect daily activities.
  • If taking specific PAH medications, must be on a stable dose of these medications for at least 30 days before starting the study and continue this stable dose throughout the study. These medications include **endothelin receptor antagonists (ERA)**, **PDE5 inhibitors**, or **soluble guanylate cyclase (sGC) stimulators**. If taking a PDE5 inhibitor for erectile dysfunction, it is allowed up to 3 times a week.
  • Must be able to walk at least 150 meters in a **6-minute walk distance (6MWD)** test, which measures how far a person can walk in 6 minutes.
  • If taking other medications that might affect PAH symptoms, such as **calcium channel blockers, diuretics, digoxin, L-arginine supplements, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers**, the dose must be stable for at least 30 days before starting the study and remain stable during the study. Diuretics must be stable for at least 10 days before starting the study.
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Investigated drugs

Ralinepag is a medication being studied for its potential to improve treatment outcomes in patients with pulmonary arterial hypertension (PAH). The main goal of the study is to see how well ralinepag can delay the time until a patient's condition worsens according to specific criteria set by the study.

What is already known about the treatment

Ralinepag – Ralinepag is administered orally and is currently being studied for its effectiveness and safety in treating pulmonary arterial hypertension (PAH). It is in the clinical trial phase, with ongoing research to evaluate its impact on delaying clinical worsening in PAH patients. The medication works by targeting specific receptors in the body to help relax blood vessels and improve blood flow, thereby reducing the pressure in the arteries of the lungs. Ralinepag is classified as a prostacyclin receptor agonist, which means it mimics the action of natural substances in the body that help to dilate blood vessels.

Investigated diseases

Pulmonary Arterial Hypertension (PAH) – Pulmonary arterial hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may become enlarged and weakened due to the increased workload. The disease progresses as the blood vessels in the lungs become more narrowed or blocked, further increasing the pressure. This can lead to a reduced ability to exercise and perform daily activities. As the condition advances, it may cause complications affecting the heart and other organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509304-16-00Protocol codeROR-PH-301Estimated enrolment765 patientsSponsorUnited Therapeutics Corp.

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