Sotatercept for Pulmonary Arterial Hypertension

University of California Irvine ( Site 1086), Orange, CA
Pulmonary Arterial Hypertension+15 More ConditionsSotatercept - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can help people with a certain kind of heart problem.

Eligible Conditions
  • 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

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 24 Secondary · Reporting Duration: Up to approximately 46 months

Baseline and Week 24
Change From Baseline in 6-MWD at Week 24
Change From Baseline in Cardiac Output (CO) at Week 24
Change From Baseline in EuroQoL-5 Dimensions Scale 5 Levels (EQ-5D-5L) Index Score at Week 24
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 24
Change From Baseline in NT-proBNP levels at Week 24
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Change From Baseline in REVEAL Lite 2 Risk Score at Week 24
Week 24
Change from baseline in 6MWD.
Change from baseline in EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L) index score at Week 24.
Month 46
Time to first confirmed morbidity or mortality event.
From randomization to the end of the double-blind, placebo-controlled (DBPC) treatment period (EOT).
Proportion of participants who improve in WHO FC.
Week 24
Change from baseline in NT-proBNP levels.
Change from baseline in REVEAL Lite 2 risk score.
Change from baseline in cardiac output (CO) at Week 24.
Change from baseline in mean pulmonary artery pressure (mPAP) at Week 24.
Change from baseline in pulmonary vascular resistance (PVR).
Proportion of participants achieving a low or intermediate (≤ 7) REVEAL Lite 2 risk score at Week 24.
Month 46
Overall survival
Proportion of participants who experienced a mortality event.
Transplant-free survival.
Month 46
Overall survival (OS)
Percentage of Participants Who Experienced a Mortality Event
Percentage of Participants Who Improve in WHO FC
Time to First Confirmed Morbidity or Mortality Event
Transplant-Free Survival
Week 24
Percentage of Participants Achieving a Low or Intermediate (≤7) REVEAL Lite 2 Risk Score at Week 24

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Sotatercept 0.1 mg/kg
43%Headache
29%Oedema peripheral
14%Bronchitis
14%Thrombocytopenia
14%Vitreous floaters
14%Stomatitis
14%Chest discomfort
14%Toothache
14%Back pain
14%Dizziness
14%Influenza
14%Abdominal pain upper
14%Cough
14%Pruritus
14%Urinary tract infection
14%Ataxia
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01736683) in the Sotatercept 0.1 mg/kg ARM group. Side effects include: Headache with 43%, Oedema peripheral with 29%, Bronchitis with 14%, Thrombocytopenia with 14%, Vitreous floaters with 14%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Sotatercept plus background PAH therapy
Drug
Experimental Group · 1 Intervention: Sotatercept · Intervention Types: Drug
Placebo plus background PAH therapy
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 46 months

Who is running the clinical trial?

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor
32 Previous Clinical Trials
4,317 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,813 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
3,140 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,813 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
32 Previous Clinical Trials
4,317 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,813 Patients Enrolled for Pulmonary Arterial Hypertension
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,669 Previous Clinical Trials
7,958,867 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
2,395 Patients Enrolled for Pulmonary Arterial Hypertension
John Buttler, MDStudy DirectorAcceleron Pharma Inc.

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 Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I've never been given any drugs."
How many prior treatments have patients received?
0100.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.