Testing Sotatercept for pulmonary arterial hypertension
Official title: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
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)
Interventions
Sotatercept
Sotatercept SC injection every 3 weeks
Canadian Sites (3)
Peter Lougheed Centre ( Site 2102)
Calgary, Alberta, Canada
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
St. Joseph's Healthcare Hamilton ( Site 2105)
Hamilton, Ontario, Canada
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more → requirements
- +Must have the ability to understand and provide documented informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
Exclusion
- −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 eventSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
- −Is or has an immediate family member who is investigational siteTrial siteA hospital or clinic where a study is actually run.Read more → or SponsorSponsorThe organisation responsible for the study overall.Read more → staff directly involved with this study
- −Is currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another investigational product study other than a sotatercept study
- −Is incapacitated
- −Is a female who is pregnant or breastfeeding
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Sotatercept.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 815 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Up to approximately 90 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants Who Experience an Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) — measured over Up to approximately 90 months.
Number of Participants Who Discontinue Study Treatment Due to an AE — measured over Up to approximately 86 months.
Number of Participants with Detectable Anti-Drug Antibodies (ADAs) — measured over Up to approximately 88 months.
Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin — measured over Up to approximately 88 months.
The study lists 4 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07218029 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SotaterceptBiological
Sotatercept SC injection every 3 weeks
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 90 months.
The study as a whole is currently expected to finish around 2028-12-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 815 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Minneapolis, Minnesota, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
University of Minnesota ( Site 1062)
Minneapolis, Minnesota, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.