Study of Sotatercept for Patients with Severe Pulmonary Arterial Hypertension at High Risk of Mortality

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What is this study about?

This clinical trial is focused on studying Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The study is evaluating a treatment called sotatercept, which is given as a solution for injection. Sotatercept is also known by the code name MK-7962. The purpose of the study is to assess the effects of sotatercept when added to the maximum tolerated background therapy for PAH, compared to a placebo, in participants who are at high risk of mortality and classified as World Health Organization (WHO) Functional Class III or IV.

Participants in the study will receive either sotatercept or a placebo, in addition to their existing PAH therapy. The study will monitor the time to the first event of all-cause death, lung transplantation, or PAH worsening-related hospitalization lasting 24 hours or more. The study aims to understand how sotatercept affects these outcomes in people with severe PAH. The treatment period is expected to last up to 40 weeks, during which participants will have regular check-ups and assessments to track their health and response to the treatment.

This study is designed to provide valuable information on the potential benefits of sotatercept for individuals with severe PAH, helping to determine if it can improve survival and reduce the need for lung transplantation or hospitalization due to worsening PAH. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of pulmonary arterial hypertension (PAH), and stability on current PAH therapies.

Participants must be between 18 and 75 years old and have a confirmed diagnosis of PAH through right heart catheterization.

2 initial assessment

An initial assessment is conducted to document the participant’s health status and confirm the diagnosis of PAH.

This includes a right heart catheterization to measure pulmonary vascular resistance and other heart pressures.

3 treatment phase

Participants receive either the study drug, sotatercept, or a placebo. Both are administered as a solution for injection under the skin (subcutaneous).

The treatment is given in addition to the participant’s maximum tolerated background PAH therapy.

4 monitoring and follow-up

Participants are monitored regularly to assess the effects of the treatment. This includes checking for any worsening of PAH, hospitalizations, or other health events.

Regular follow-up visits are scheduled to evaluate overall health, including changes in exercise capacity and heart function.

5 end of study

The study concludes with a final assessment to determine the overall impact of the treatment on the participant’s health.

Participants are evaluated for any changes in their condition and the need for further treatment is assessed.

Who Can Join the Study?

Participants must be between the ages of 18 and 75.
Participants need to have a confirmed diagnosis of Pulmonary Arterial Hypertension (PAH) through a test called right heart catheterization. This test checks the pressure in the heart and lungs.
Participants should have symptomatic PAH, which means they have noticeable symptoms, and it should be classified as WHO FC III or IV. These are categories that describe the severity of the condition.
Participants must have a REVEAL Lite 2.0 risk score of 9 or higher. This score helps to assess the risk level of the disease.
During screening, or within two weeks before, another right heart catheterization should show a PVR (Pulmonary Vascular Resistance) of 5 or more Wood units and a PCWP (Pulmonary Capillary Wedge Pressure) or LVEDP (Left Ventricular End-Diastolic Pressure) of 15 mmHg or less. These measurements help to understand the pressure in the lungs and heart.
Participants should be clinically stable and on stable doses of the maximum tolerated PAH therapies for at least 30 days before screening. This means their treatment should not have changed recently.
Females who can have children must have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing. They must use highly effective birth control methods before and during the study and for 16 weeks after the last dose of the study drug.
Male participants must agree to use a condom during sexual contact with a pregnant female or a female who can have children while in the study and for 16 weeks after the last dose. They should also not donate blood or sperm during this time.
Participants must be able to attend all study visits and follow all study requirements.
Participants must be able to understand and sign a written consent form to participate in the study.

Who Cannot Join the Study?

Patients who have a different condition than Pulmonary Arterial Hypertension (PAH) cannot participate.
Patients who are not at high risk of mortality with WHO FC III or FC IV PAH are excluded. WHO FC III and FC IV are classifications that describe the severity of PAH symptoms.
Patients who cannot tolerate the maximum background PAH therapy are excluded. This means if the patient cannot handle the highest dose of their current PAH treatment, they cannot join.
Patients who have had a lung transplant or are on the waiting list for one cannot participate.
Patients who have been hospitalized for PAH worsening for less than 24 hours are excluded.
Patients who are not within the specified age range for the study cannot participate. The study includes adults and older adults.
Patients who are not willing or able to follow the study procedures and requirements are excluded.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Multimedica S.p.A.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Saarland University Hospital	Homburg	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Krankenhaus Neuwittelsbach	Munich	Germany
Uxuwedrwna Hwvapwlz Cfvmgel	Cologne	Germany
Aoiocbxmw Usb	Amsterdam	The Netherlands
Csjf Dz Nsbpx	Vandoeuvre Les Nancy	France
Umwjqavubh Dfdix Snrzh Dg Rzxw Lz Saovldxs	Rome	Italy
Cemxva Hhdcitaxnch Rzbrnywj Ddctzwfwxfragz	Angers	France
Hrzepxik Uxxhuvniwizoyf Szeillvmoi &bapqjy Hrvdnuj dt Hgjsaxgxwyy	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2021
France	Not recruiting	01.10.2021
Germany	Not recruiting	01.10.2021
Italy	Not recruiting	01.10.2021
Spain	Not recruiting	01.10.2021
The Netherlands	Not recruiting	01.10.2021

Trial locations

Investigated drugs:

Sotatercept

Sotatercept is a medication being studied for its potential to help people with pulmonary arterial hypertension (PAH), a condition that affects the blood vessels in the lungs and can lead to heart failure. In this trial, sotatercept is added to the maximum tolerated background therapy that participants are already receiving for PAH. The goal is to see if sotatercept can improve outcomes such as reducing the risk of death, the need for lung transplantation, or hospitalization due to worsening PAH symptoms.

Pulmonary Arterial Hypertension (PAH) – 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 narrowed 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 eventual heart failure. Symptoms often include shortness of breath, fatigue, chest pain, and swelling in the legs and ankles. Over time, the condition can progress, causing more severe symptoms and complications. It is considered a rare disease and can significantly impact a person’s quality of life.

Trial ID:

2023-509140-10-00

Protocol code:

A011-14

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Sotatercept for Patients with Severe Pulmonary Arterial Hypertension at High Risk of Mortality

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