A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Official title

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Overview

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Detailed description

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

Interventions

• Biological Sotatercept
  Sotatercept SC injection every 3 weeks

Primary outcome measures

• Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 90 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 86 months]
• Number of Participants with Detectable Anti-Drug Antibodies (ADAs) [Time frame: Up to approximately 88 months]
• Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin [Time frame: Up to approximately 88 months]
• Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) [Time frame: Up to approximately 86 months]
• Change From Baseline in Body Weight [Time frame: Baseline and up to approximately 86 months]
• Change From Baseline in Blood Pressure [Time frame: Baseline and up to approximately 86 months]
• Change From Baseline in Electrocardiogram (ECG) [Time frame: Baseline and up to approximately 86 months]

Secondary outcome measures (5)

• Change From Baseline in 6-Minute Walk Distance (6MWD) [Time frame: Baseline and up to approximately 48 months]
• Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels [Time frame: Baseline and up to approximately 48 months]
• Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC) [Time frame: Baseline and up to approximately 48 months]
• Change From Baseline in Pulmonary Vascular Resistance (PVR) [Time frame: Baseline and up to approximately 48 months]
• Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator [Time frame: Baseline and up to approximately 48 months]

Eligibility criteria

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
• Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
• Must have the ability to understand and provide documented informed consent

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Did not participate in a sotatercept PAH parent study
• Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
• Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
• Is a female who is pregnant or breastfeeding
• Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
• Is currently enrolled in another investigational product study other than a sotatercept study
• Is incapacitated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 35 centers

• Pulmonary Associates, PA ( Site 1008) — Phoenix
• Arizona Pulmonary Specialists ( Site 1010) — Scottsdale
• University of Arizona ( Site 1006) — Tucson
• University of California San Diego Health ( Site 1002) — La Jolla
• UC Irvine Health Medical Center ( Site 1086) — Orange
• UC Davis - Medial Center ( Site 1064) — Sacramento
• UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) — San Francisco
• Jeffrey S. Sager, MD Medical Corporation ( Site 1060) — Santa Barbara
• … and 27 more centers

France · 13 centers

• Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) — Nice
• CHU Bordeaux Haut-Leveque ( Site 1312) — Pessac
• Nouvel Hôpital Civil (NHC) ( Site 1307) — Strasbourg
• Hopital Cavale Blanche ( Site 1314) — Brest
• Hopital Larrey ( Site 1315) — Toulouse
• CHU de Grenoble Hopital Nord ( Site 1303) — La Tronche
• Hopital Nord Laennec ( Site 1309) — Saint-Herblain
• CHU Angers ( Site 1313) — Angers
• … and 5 more centers

Germany · 10 centers

• Thoraxklinik-Heidelberg gGmbH ( Site 1509) — Heidelberg
• Krankenhaus Neuwittelsbach ( Site 1510) — München
• Universitaetsklinik Regensburg ( Site 1503) — Regensburg
• UKGM Gießen/Marburg ( Site 1512) — Giessen
• Medizinische Hochschule Hannover ( Site 1505) — Hanover
• … and 5 more centers

Spain · 9 centers

Center list to be confirmed — check the primary protocol.

Argentina · 7 centers

• Instituto de Investigaciones Clinicas Quilmes ( Site 1903) — Quilmes
• Instituto Médico Río Cuarto ( Site 1907) — Río Cuarto
• Sanatorio Parque ( Site 1905) — Rosario
• Instituto Cardiovascular de Rosario ( Site 1906) — Rosario
• Hospital Provincial del Centenario ( Site 1912) — Rosario
• Sanatorio Allende ( Site 1908) — Córdoba
• Hospital Provincial Dr. Jose M. Cullen ( Site 1902) — Santa Fe

United Kingdom · 7 centers

Center list to be confirmed — check the primary protocol.

Australia · 6 centers

• Royal Prince Alfred Hospital ( Site 1106) — Camperdown
• The Prince Charles Hospital ( Site 1104) — Chermside
• John Hunter Hospital ( Site 1101) — New Lambton Heights
• Royal Adelaide Hospital ( Site 1109) — Adelaide
• Royal Hobart Hospital ( Site 1107) — Hobart
• Fiona Stanley Hospital ( Site 1103) — Murdoch

Israel · 4 centers

Center list to be confirmed — check the primary protocol.

Italy · 4 centers

Center list to be confirmed — check the primary protocol.

Brazil · 3 centers

• Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) — Porto Alegre
• Hospital Dia do Pulmao ( Site 1802) — Blumenau
• Instituto do Coracao - HCFMUSP ( Site 1803) — São Paulo

Greece · 3 centers

Center list to be confirmed — check the primary protocol.

Serbia · 3 centers

Center list to be confirmed — check the primary protocol.

South Korea · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 2 centers

• Université Libre de Bruxelles - Hôpital Erasme ( Site 1402) — Brussels
• UZ Leuven ( Site 1401) — Leuven

Canada · 2 centers

• Peter Lougheed Centre ( Site 2102) — Calgary
• University of Alberta Hospital ( Site 2101) — Edmonton

Colombia · 2 centers

• Fundación Neumológica Colombiana ( Site 3403) — Bogotá
• Clínica Imbanaco S.A.S ( Site 3404) — Cali

Czechia · 2 centers

• Institut Klinicke a Experimentalni Mediciny ( Site 2202) — Prague
• Vseobecna fakultni nemocnice v Praze ( Site 2201) — Prague

Denmark · 2 centers

• Rigshospitalet ( Site 3802) — København Ø
• Aarhus Universitetshospital, Skejby ( Site 3801) — Aarhus

Netherlands · 2 centers

Center list to be confirmed — check the primary protocol.

Poland · 2 centers

Center list to be confirmed — check the primary protocol.

Portugal · 2 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 2 centers

Center list to be confirmed — check the primary protocol.

Croatia · 1 center

• Klinicki Bolnicki Centar Split ( Site 3901) — Split

New Zealand · 1 center

Center list to be confirmed — check the primary protocol.

Sweden · 1 center

Center list to be confirmed — check the primary protocol.

Switzerland · 1 center

Center list to be confirmed — check the primary protocol.

Publications

• Preston IR, Badesch D, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Humbert M, McLaughlin VV, Waxman AB, Manimaran S, Mikhailova E, Reddy M, Lau A, de Oliveira Pena J, Souza R. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025 Jul 24;66(1):2401435. doi: 10.1183/13993003.01435-2024. Print 2025 Jul. PMID 39978862

Identifiers

NCT: NCT07218029 · 7962-038 · 2025-521970-33-00 · U1111-1321-4943 · MK-7962-038 · MK-7962-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗