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
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany
CHU Grenoble Alpes	La Tronche	France
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium
DRK Kliniken Berlin	Berlin	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Saarland University Hospital	Homburg	Germany
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Onassis Cardiac Surgery Center	Kallithea	Greece
Exbddipnzvps Scrv	Athens	Greece
Unyhncqdcc Gblhgyz Htvyasfw Oe Trinzldlspzk Aossn	Thessaloniki	Greece
Hqupfkpq Vpew dgixztua	Barcelona	Spain
Uqztnwumfh Hszlshfj Czrsato	Cologne	Germany
Auujojxid Usn	Amsterdam	The Netherlands
Ewmzbdf Ubyftgzdanbj Msutowr Chhrrdn Rswqsjbye (znsvnww Mtw	Rotterdam	The Netherlands
Smwaorena Rvvstks Uqchlvyevq Mvgngok Ctavyv	Nijmegen	The Netherlands
Cbwjqm Hwkmrxelldv Rhbsnrlp Uxrelfwqngrkd Ds Tyfhl	Tours	France
Cyebeq Hnajroohan E Uqugnhzpbddjy Dt Cmgalhh Etowtc	Coimbra	Portugal
Akebmst Oonfesoinha Ucsdryyugdjot Fnwpnsqn Iz Dc Ndpxtb	Naples	Italy
Cfqd Db Nwjlo	Vandoeuvre Les Nancy	France
Jeffabidxwdcjtjotsofuordrn Gablvqz	Giessen	Germany
Vuqxxdiho Farmpeuj Nzklrvbyx V Ptlnq	Prague	Czechia
Ucbdleijsg Hvkkdxoe Mxaofpnlyv	Maastricht	The Netherlands
Ubwgkqtdwgxz Lsqdwnv	Leipzig	Germany
Ttvdmqzgvbjm Hrpjgngyhx gghkh	Heidelberg	Germany
Rcitpftvcaosls	Copenhagen	Denmark
Kkf Stbpq	Split	Croatia
Udabirsllq Dlmir Sfygn Dd Regx Le Sikxppuz	Rome	Italy
Okuohtlxhhtwnr Lrup Glhm	Linz	Austria
Iwkshcwjf Fnz Clobtnwr Adq Eeyvljkzgrwc Mwjkfdlb	Prague	Czechia
Cxogwj Hondcnwkrqc Loes Sji	Pierre Benite	France
Hrvnlxsu Uqpsqiebvkpxn Piohma Dv Hftmlz Dy Minesvmrssl	Majadahonda	Spain
Hhdvxyfw Univavhbgkpda 1a Dc Ojwforq	Madrid	Spain
Hudtgjym Ubtrmhiosoutn Marucnx Dw Vpcdmjvcos	Santander	Spain
Cxaunl Hltihiqscoq Ralagkvj Dngmhlssawieuv	Angers	France
Seuiiz Dd Skznr De Lpb Isydg Bocfrny	Palma	Spain
Fdeljouio Ppcv Lg Ieitfnafdogqd Boizshpaj Duu Hdnyvkoq Uwcnlaumqbwmt Ll Pia	Madrid	Spain
Faonpobebl Iikhp Sou Gqcvdxx Dml Tpokecc	Monza	Italy
Hbbuidic Urhttoxmeduzfs Sedtjomxed &zggqyp Hijcrsy dw Htnytbecnme	STRASBOURG, Alsace	France
Udguufjmat Gztvzmd Hlbgxheb Ahcddxa Gtebitj Hlbkaraa Ov Wpwg Abbdjj H Adhz Vxzyzkv	Chaidari	Greece
Argynyr Smrssljef Uwrkwdtqjvcoy Gmhrvqaf Ixomtoau	Trieste	Italy
Iwlimbqd du Crnoqiygnejr Hqgxwbmdynb Uzsvlprgxhgnn dt Snmfc Ewcrobp (tzepbtl	Saint Priest En Jarez	France
Uqlkpxexcfnpfjmxlvzvv Ruuvuhtwfj Abr	Regensburg	Germany
Aiigwl Udqvcegjtb Hqwfncqn	Aarhus	Denmark
Chzupt Hgwugkwktlj Uhdlmcplbyayr Dl Pcfengrz	Poitiers	France
Mnyzxfwlyjdvdwjhtnhgehkibj Hsfpjiguqjgxtplh	Halle (Saale)	Germany
Mgjihnoyasy Sumunp	Milan	Italy
Kdfxanprw Sfdhgse Sitzjfymekqphce ij Jrel Psbja If	Cracow	Poland
Kyyofvpqjrk Nkjdqphjgnjgad	Munich	Germany

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.

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?

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