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Study on the Safety and Effectiveness of Cibotercept (KER-012) with Other Drugs for Adults 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 will investigate a treatment called KER-012, which is a solution for injection. KER-012 is a recombinant fusion protein, meaning it is a specially designed protein that combines parts from different sources to help treat the disease. The trial will compare the effects of KER-012 with a placebo, which is a substance with no active medication, to see how well KER-012 works in combination with other PAH therapies that participants are already receiving.

The purpose of the study is to evaluate the safety and effectiveness of KER-012 in improving the condition of patients with PAH. Participants will receive either KER-012 or a placebo, and the study will monitor changes in their health over time. The trial will last for a period of up to 96 weeks, during which participants will have regular check-ups to assess their response to the treatment. The main focus will be on how KER-012 affects the blood flow in the lungs and the ability of participants to perform physical activities, such as walking.

Throughout the study, researchers will also keep track of any side effects or adverse reactions that participants may experience. This will help determine the overall safety of KER-012. The study aims to provide valuable information on whether KER-012 can be a beneficial addition to existing PAH treatments, potentially improving the quality of life for those living with this challenging condition.

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

    Joining the study

    Upon joining the study, the participant will be required to provide written consent. This involves signing and dating a consent form to confirm understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility. This includes checking age, symptoms, and specific health parameters related to pulmonary arterial hypertension (PAH).

    The participant must have stable PAH therapy and meet certain health criteria, such as specific blood pressure measurements and walking distance capabilities.

  3. Step 3

    Treatment administration

    The participant will receive either the study medication, KER-012, or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous).

    The dosage and frequency of administration will be determined by the study protocol and will continue throughout the study duration.

  4. Step 4

    Ongoing monitoring

    Throughout the study, the participant will be monitored for changes in pulmonary vascular resistance and other health indicators.

    Regular assessments will include measuring the distance walked in six minutes and checking for any adverse effects from the treatment.

  5. Step 5

    Completion of study

    The study is expected to conclude by the end of 2026. At the end of the study, the participant's health data will be analyzed to evaluate the effects of the treatment.

Who can join the trial?

13 criteria

  • Participants must be adults, aged 18 years or older.
  • Participants should have symptoms of **Pulmonary Arterial Hypertension (PAH)**, which is a type of high blood pressure that affects the lungs and heart. This can be classified as:
    • Idiopathic PAH, meaning the cause is unknown.
    • Hereditary PAH, meaning it runs in families.
    • PAH caused by drugs or toxins.
    • PAH associated with:
      • Connective tissue disease, which affects the tissues that support and connect different parts of the body.
      • A heart condition that has been surgically corrected at least a year before the study, with no significant leftover issues.
      • Participants must have certain heart and lung measurements that match the PAH diagnosis:
        • Mean pulmonary arterial pressure (mPAP) greater than 20 mmHg at rest.
        • Pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg.
        • Pulmonary vascular resistance (PVR) of at least 5 Wood units.
        • Participants should have symptoms that are classified as **WHO/New York Heart Association (NYHA) Functional Class II or III**, which indicates a certain level of physical activity limitation due to PAH.
        • Participants must be on a stable PAH treatment plan, which includes medications like endothelin-receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators, or prostacyclin analogues. The treatment should not have changed for at least 90 days before the study starts.
        • Participants must be able to walk a distance between 150 and 500 meters in a test called the **6-minute walk distance (6MWD)**, done twice during the screening period. The results of these tests should be similar to each other.
        • Participants must provide written consent to join the study, which means they agree to participate after understanding the study details.

Who cannot join the trial?

10 criteria

  • Participants with any other serious health condition that could interfere with the study.
  • Individuals who have had a recent heart attack or stroke.
  • People with severe liver or kidney disease.
  • Participants who are pregnant or breastfeeding.
  • Individuals who are currently participating in another clinical trial.
  • People who have had an allergic reaction to similar medications in the past.
  • Participants with uncontrolled high blood pressure.
  • Individuals with a history of drug or alcohol abuse.
  • People who have been diagnosed with cancer in the past five years.
  • Participants who have had a major surgery within the last three months.
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Investigated drugs

KER-012 is an investigational medication being studied for its potential to improve blood flow in the lungs of patients with pulmonary arterial hypertension (PAH). This medication is being tested to see if it can help reduce the pressure in the blood vessels of the lungs, which can improve symptoms and overall heart function in people with PAH. It is used in combination with other standard treatments for PAH to assess its added benefits.

What is already known about the treatment

KER-012 – KER-012 is administered orally and is currently being studied in clinical trials for its potential use in treating pulmonary arterial hypertension (PAH). This medication is in the investigational stage, with ongoing research to determine its safety and effectiveness. The main therapeutic indication for KER-012 is to improve pulmonary hemodynamics in patients with PAH. At the molecular level, KER-012 works by modulating specific pathways involved in blood vessel function, aiming to reduce the pressure in the arteries of the lungs. It is classified pharmacologically as a potential treatment for cardiovascular conditions, specifically targeting pulmonary hypertension.

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 difficult for blood to flow through the lungs. As a result, the heart has to work harder to pump blood through these arteries, which can lead to symptoms such as shortness of breath, fatigue, and dizziness. Over time, the increased workload on the heart can cause the right side of the heart to become enlarged and weakened. PAH can progress gradually, with symptoms worsening over time if not managed. 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 IITrial ID2022-502378-17-00Protocol codeKER-012-A201Estimated enrolment90 patientsSponsorKeros Therapeutics Inc.

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