Study Summary
This trial is testing a new drug to see if it can help people with a certain kind of heart problem.
- Pulmonary Arterial Hypertension
- Severe Pulmonary Arterial Hypertension
- Pulmonary Arterial Hypertension (PAH)
- Pulmonary Arterial Hypertension of Congenital Heart Disease
- Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
- Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
- Pulmonary Arterial Hypertension Gene Expression
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 24 Secondary · Reporting Duration: Up to approximately 46 months
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Sotatercept plus background PAH therapy
1 of 2
Placebo plus background PAH therapy
1 of 2
Experimental Treatment
Non-Treatment Group
200 Total Participants · 2 Treatment Groups
Primary Treatment: Sotatercept · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I've never been given any drugs."
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
Are there other notable examples of Sotatercept's efficacy?
"Currently, there are five clinical trials studying Sotatercept with four of them in Phase 3. While a few of the Sotatercept trials are situated in Tours, Indre-et-Loire, there are a total of 714 sites running these sorts of studies." - Anonymous Online Contributor
When might Sotatercept receive FDA approval?
"Sotatercept's Phase 3 status indicates that, while there is some evidence of efficacy, the primary focus is on safety. Therefore, it receives a score of 3." - Anonymous Online Contributor
Could you inform me of how many different hospitals are conducting this research?
"To date, this clinical study has recruited patients from 24 different locations, including Peter Lougheed Centre ( Site 2102) in Calgary, Alberta, University of Cincinnati Medical Center ( Site 1035) in Cincinnati, Ohio, and Arizona Pulmonary Specialists ( Site 1010) in Phoenix, Arizona." - Anonymous Online Contributor
Will this study's benefits be reaped by those who are not yet of retirement age?
"This trial is only for adults aged 18-75. There are 55 other trials for minors and 693 for seniors." - Anonymous Online Contributor
Who can join this clinical trial and start receiving treatment?
"This study is investigating a potential new treatment for pulmonary arterial hypertension. To be eligible, patients must be between 18-75 years old. So far, 200 patients have been enrolled in the clinical trial." - Anonymous Online Contributor
Are there any current vacancies for patients in this clinical trial?
"The online clinical trials database indicates that this study is actively recruiting participants. The listing was first posted on December 1, 2021 and was last updated on October 28, 2022." - Anonymous Online Contributor
What is the therapeutic goal of this clinical trial?
"The primary outcome of this trial is to evaluate Time to first confirmed morbidity or mortality event over a period of up to approximately 46 months. The secondary outcomes include Transplant-free survival, which is defined as Time from randomization to lung transplantation or death from any cause, Change from baseline in EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L) index score at Week 24, which is defined as EQ 5D 5L index score measures health-related quality of life states in adults, and Change From Baseline in EuroQoL-5 Dimensions Scale 5 Levels (E" - Anonymous Online Contributor
What is the largest number of people who can join this clinical trial?
"Yes, the information available on clinicaltrials.gov supports that this study is currently looking for test subjects. The trial was first announced on December 1st, 2021 and has had one edit on October 28th, 2022. They are looking for 200 participants total, which will be drawn from 24 different hospitals." - Anonymous Online Contributor
Have there been any other similar clinical trials like this one before?
"Sotatercept's journey begins in 2021 with the first clinical trial. This study, which had 324 participants, was sponsored by Acceleron Pharma Inc. Following the success of this initial Phase 3 drug trial, Sotatercept received approval and 5 active studies involving the medication popped up in 28 countries across 205 cities." - Anonymous Online Contributor