Study of Sotatercept for Newly Diagnosed Intermediate- and High-risk Pulmonary Arterial Hypertension Patients

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What is this study about?

This clinical trial is focused on studying a condition known as Pulmonary Arterial Hypertension (PAH), which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study is investigating a treatment called sotatercept, also known by its code name MK-7962, which is administered as a solution for injection. The purpose of the study is to evaluate the effects of sotatercept when added to existing PAH therapies in patients who have been newly diagnosed with intermediate- or high-risk PAH.

Participants in the study will receive either sotatercept or a placebo, in addition to their current PAH treatment. The study will monitor the participants over a period to assess the impact of the treatment on their condition. The trial aims to understand how sotatercept affects the progression of PAH and whether it can improve the health outcomes for those affected by this disease.

The study will involve regular check-ups and assessments to track the participants’ health and response to the treatment. This includes monitoring exercise performance and other health indicators related to PAH. The trial is designed to provide valuable information on the potential benefits of sotatercept for individuals with PAH, contributing to the development of more effective treatment options for this challenging condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, sotatercept, or a placebo. Both will be administered in addition to the participant’s existing treatment for pulmonary arterial hypertension (PAH).

2 medication administration

The study medication, sotatercept, is provided as a powder for injection. It is administered as a subcutaneous injection, which means it is injected under the skin.

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

3 monitoring and assessments

Participants will undergo regular monitoring and assessments to evaluate the effects of the treatment. This includes exercise testing, blood tests, and other evaluations to monitor heart function and overall health.

The primary goal is to assess the time to clinical worsening (TTCW), which includes events such as hospitalization, worsening of symptoms, or changes in treatment needs.

4 follow-up visits

Participants will attend scheduled follow-up visits throughout the study duration. These visits are essential for tracking progress and ensuring the safety and effectiveness of the treatment.

During these visits, participants will be asked about any side effects or changes in their condition.

5 study completion

The study is expected to continue until August 2029. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment.

Participants will be informed about the study results and any potential next steps regarding their treatment.

Who Can Join the Study?

Must be 18 years or older.
Must have a right heart catheterization test done within the last 12 months showing certain heart pressure measurements.
Must have a diagnosis of PAH (Pulmonary Arterial Hypertension), which is a type of high blood pressure affecting the lungs and heart, in specific subtypes like idiopathic, heritable, drug-induced, or associated with certain conditions.
Must have symptoms of PAH that are classified as WHO FC II or III, which are categories describing the severity of symptoms.
Must have a certain risk score indicating intermediate or higher risk of PAH progression.
Must have been diagnosed with PAH within the last 12 months and be on stable doses of PAH medications for at least 90 days before the study.
Must be able to walk at least 150 meters in a test done twice during screening, with both results being similar.
Females who can have children must have two negative pregnancy tests, agree to ongoing pregnancy testing, use effective birth control, and not breastfeed or donate eggs during the study and for a period after.
Male participants must agree to use condoms during sexual contact with women who can have children, and not donate blood or sperm during the study and for a period after.
Must be able to attend study visits and follow all study requirements.
Must be able to understand and sign a consent form agreeing to participate in the study.

Who Cannot Join the Study?

Participants who have a different type of lung disease other than PAH. PAH stands for Pulmonary Arterial Hypertension, which is high blood pressure in the lungs.
Participants who have had a heart attack or stroke in the last 6 months.
Participants who have severe liver disease. The liver is an organ that helps clean your blood and digest food.
Participants who have severe kidney disease. The kidneys are organs that help filter waste from your blood.
Participants who are pregnant or breastfeeding. This means women who are expecting a baby or are feeding a baby with breast milk.
Participants who are currently using certain medications that might interfere with the study treatment.
Participants who have a history of certain types of cancer.
Participants who have a history of drug or alcohol abuse in the past year. This means using drugs or alcohol in a way that is harmful.
Participants who have participated in another clinical trial within the last 30 days.
Participants who have any other medical condition that the study doctors think might make it unsafe for them to participate.

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
Medical University Of Vienna	Vienna	Austria
DRK Kliniken Berlin	Berlin	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
University Hospital Maastricht	Maastricht	The Netherlands
Universitaet Leipzig	Leipzig	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Onassis Cardiac Surgery Center	Kallithea	Greece
Multimedica S.p.A.	Milan	Italy
Evangelismos S.A.	Athens	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Saarland University Hospital	Homburg	Germany
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Rigshospitalet	Copenhagen	Denmark
KBC Split	Split	Croatia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Servei De Salut De Les Illes Balears	Palma	Spain
Krankenhaus Neuwittelsbach	Munich	Germany
Oboqszduqrigta Lhwv Gcpa	Linz	Austria
Iitaldkyv Fpb Cjdqasvr Atb Epeydjhtcnkd Mvkdonum	Prague	Czechia
Hmqdqhjk Utcryytiefnkb Mndozeu Ds Vpgvezesog	Santander	Spain
Uxjvaobkld Hdxxnivj Cxcgkpg	Cologne	Germany
Amewbovey Udr	Amsterdam	The Netherlands
Euurqrq Uoebxxxsbfqo Mfekshw Ccksudj Rpyqbpwyv (xvemlsm Mtw	Rotterdam	The Netherlands
Aygpyt Uuwutuawvu Hqrypwxk	Aarhus	Denmark
Cvvmgo Hkanxbkamwg Rvbmprjp Unzfrkroiulpb De Tnpmk	Tours	France
Chje Dd Ndbfo	Vandoeuvre Les Nancy	France
Uhkrlyhagz Ddvtt Syxzf Dd Rnsv Lh Szpfhzdo	Rome	Italy
Mfygiaunoeiwqceiwtwgseerdh Hunqtnmvoyekmtsq	Halle (Saale)	Germany
Chcjvg Hdrqkwufbkv Rerojhyl Dxxofgptuqurln	Angers	France
Febrfxoka Prfz Lm Ipcvouvaxpyzb Bbqqgzckw Dod Hsxinloi Uesivibgakiqj Li Pit	Madrid	Spain
Iwfwtkhl ds Cuojydieahtn Hheymwfucfl Uzijpzwxdeveq du Slpxj Egmwsei (lesewjm	Saint Priest En Jarez	France
Hfhymxqa Vtjr dbuarhvl	Barcelona	Spain
Uchflewkwr Gijmrmc Hjxxdfue Apnjlrg	Athens	Greece
Krwsxtmso Swhbfmw Swkhilbvqpmppfv iz Jcjm Pvzzh Ij	Cracow	Poland
Hmymcdcu Upjgjsyqhggoms Slrtwhblci &rkbpvi Hwimzdp dk Hhcvckllljz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2021
Belgium	Not recruiting	01.09.2021
Croatia	Not recruiting	01.09.2021
Czechia	Not recruiting	01.09.2021
Denmark	Not recruiting	01.09.2021
France	Not recruiting	01.09.2021
Germany	Not recruiting	01.09.2021
Greece	Not recruiting	01.09.2021
Italy	Not recruiting	01.09.2021
Poland	Not recruiting	01.09.2021
Portugal	Not recruiting	01.09.2021
Spain	Not recruiting	01.09.2021
The Netherlands	Not recruiting	01.09.2021

Trial locations

Investigated drugs:

Sotatercept

Sotatercept is a medication being studied for its potential to help patients with pulmonary arterial hypertension (PAH). It is being tested to see if it can improve the condition of patients who have recently been diagnosed with PAH and are at an intermediate or high risk of the disease getting worse. This medication is used in combination with other standard treatments for PAH to see if it can provide additional benefits.

Investigated diseases:

Pulmonary arterial hypertension

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 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 eventual heart failure. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. Over time, the condition can worsen, leading to more severe symptoms and complications. The progression of PAH can vary, with some individuals experiencing rapid worsening, while others may have a slower progression.

Trial ID:

2023-509139-16-00

Protocol code:

A011-13

NCT ID:

NCT04811092

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Sotatercept for Newly Diagnosed Intermediate- and High-risk Pulmonary Arterial Hypertension Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?