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

Phase 3RecruitingNCT07218029

Merck Sharp & Dohme LLC815 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

815

Conditions

Pulmonary Arterial Hypertension

SotaterceptBIOLOGICAL

Sotatercept SC injection every 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (119)

Pulmonary Associates, PA ( Site 1008)

Phoenix, Arizona, United States

ACTIVE_NOT_RECRUITING

Arizona Pulmonary Specialists ( Site 1010)

Scottsdale, Arizona, United States

RECRUITING

University of California San Diego Health ( Site 1002)

La Jolla, California, United States

ACTIVE_NOT_RECRUITING

UC Irvine Health Medical Center ( Site 1086)

Orange, California, United States

Outcomes

Primary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

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)

ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.

Time frame: Up to approximately 88 months

Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin

Blood samples will be collected to determine the concentration of platelets and hemoglobin.

Time frame: Up to approximately 88 months

Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT)

Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.

Time frame: Up to approximately 86 months

Change From Baseline in Body Weight

Change from baseline in body weight will be reported.

Time frame: Baseline and up to approximately 86 months

Change From Baseline in Blood Pressure

Change from baseline in systolic and diastolic blood pressure will be reported.

Time frame: Baseline and up to approximately 86 months

Change From Baseline in Electrocardiogram (ECG)

Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.

Time frame: Baseline and up to approximately 86 months

Secondary Outcomes

Change From Baseline in 6-Minute Walk Distance (6MWD)

The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported.

Time frame: Baseline and up to approximately 48 months

Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels

NT-proBNP is a circulating biomarker that reﬂects myocardial stretch. The change from baseline in NT-proBNP levels will be reported.

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)

The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classiﬁcation for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classiﬁed as "Improved", "No change", or "Worsened". Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported.

Time frame: Baseline and up to approximately 48 months

Change From Baseline in Pulmonary Vascular Resistance (PVR)

PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported.

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

The simpliﬁed French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. 'Low risk' is deﬁned as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD \>440 meters, and NT-proBNP \<300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simpliﬁed French Risk score will be reported.

Central Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)

San Francisco, California, United States

ACTIVE_NOT_RECRUITING

Jeffrey S. Sager, MD Medical Corporation ( Site 1060)

Santa Barbara, California, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)

Torrance, California, United States

ACTIVE_NOT_RECRUITING

University of Colorado Hospital ( Site 1013)

Aurora, Colorado, United States

ACTIVE_NOT_RECRUITING

Mayo Clinic Jacksonville ( Site 1045)

Jacksonville, Florida, United States

ACTIVE_NOT_RECRUITING

AdventHealth Orlando ( Site 1058)

Orlando, Florida, United States

RECRUITING

...and 109 more locations

Time frame: Baseline and up to approximately 48 months

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

Overview

Conditions

Interventions

Eligibility

Locations (119)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts