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Sotatercept for Pulmonary Arterial Hypertension

Phase 3
Waitlist Available
Research Sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 18 months
Awards & highlights

Study Summary

This trial is testing a new drug for PAH, to see if it is more effective and has fewer side effects than current treatments.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced an Adverse Event (AE)
Secondary outcome measures
Change From Baseline in NT-proBNP Levels at Week 24
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
+6 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988
20%
Headache
15%
COVID-19
12%
Diarrhoea
12%
Epistaxis
10%
Telangiectasia
10%
Nausea
10%
Fatigue
10%
Dizziness
7%
Injection site pain
6%
Hypokalaemia
6%
Rash
6%
Flushing
5%
Oedema peripheral
5%
Thrombocytopenia
4%
Nasopharyngitis
3%
Urinary tract infection
2%
Dyspnoea
1%
Inguinal hernia
1%
Pulmonary arterial hypertension
1%
Atrial flutter
1%
Iron deficiency
1%
Bronchitis
1%
Fall
1%
Supraventricular tachycardia
1%
Abdominal pain
1%
Pancreatitis
1%
Cellulitis
1%
Pneumonia
1%
Pneumonia influenzal
1%
Respiratory tract infection
1%
Sepsis
1%
Upper respiratory tract infection
1%
Osteoporotic fracture
1%
Acute kidney injury
1%
Haemoptysis
1%
Pulmonary artery aneurysm
1%
Upper gastrointestinal haemorrhage
1%
Joint injury
1%
Sjogren's syndrome
1%
Cerebral haematoma
1%
Device malfunction
1%
Nephritis
1%
Sarcoidosis
1%
Gastroenteritis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)
Placebo Plus Background PAH Therapy (LTDB Period)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotatercept plus background PAH therapyExperimental Treatment2 Interventions
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy
Group II: Placebo plus background PAH therapyPlacebo Group2 Interventions
Placebo administered (SC) every 21 days plus background PAH therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
2019
Completed Phase 3
~680
Background PAH Therapy
2021
Completed Phase 3
~330

Find a Location

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
3,943 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,437 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,721 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,437 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
3,943 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,437 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum dosage of Sotatercept that is safe for patients?

"Sotatercept has received a score of 3 for safety. This is due to the Phase 3 status of the medication, indicating that not only is there some evidence of efficacy, but multiple rounds of data support the safety of the drug."

Answered by AI

Does this research differ significantly from other work that has been done in this area?

"As of now, there are 5 ongoing studies for Sotatercept in 205 different cities and 28 countries. The first trial occurred in 2021 and was completed successfully by Acceleron Pharma Inc. (a subsidiary of Merck Sharp and Dohme, which is in turn owned by Merck & Co., Inc.). A total of 324 patients participated in the Phase 3 clinical trial. Since then, 18245 more trials have been conducted."

Answered by AI

Across how many different states is this trial being conducted?

"There are many locations where this trial is accepting patients, for example Brigham and Women's Hospital (Site 1014) in Cincinnati, Ohio, The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001) in Tucson, Arizona, and University of Arizona (Site 1006) in Ann Arbor, Michigan."

Answered by AI

What are the most similar medical studies to the Sotatercept clinical trial?

"Sotatercept was first researched in 2021 at Tufts Medical Center - PPDS (Site 1012). So far, there have been 18,245 completed studies. Right now, there are 5 studies that are actively recruiting, with a majority of these located in Cincinnati, Ohio."

Answered by AI

How many patients are included in the data set for this research?

"Right now, this particular study is not enrolling any more patients. It was initially posted on January 25th, 2021 and was last updated on September 28th, 2022. If you are looking for similar studies, 779 trials for pulmonary arterial hypertension and 5 for Sotatercept are still admitting patients."

Answered by AI

Are currently seeking participants for this clinical trial?

"This particular trial is no longer looking for new recruits. It was first posted on January 25th, 2021 and last updated September 28th, 2022. There are, however, 779 other studies recruiting patients with pulmonary arterial hypertension and 5 Sotatercept trials currently looking for new participants."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
2021. "A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04576988.
~76 spots leftby Apr 2025
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