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Sotatercept for Pulmonary Arterial Hypertension(SOTERIA Trial)

Phase 3
Recruiting
Research Sponsored by Acceleron Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 78 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

SOTERIA Trial Summary

This trial is testing a drug to see if it's safe and effective for treating Pulmonary Arterial Hypertension.

Eligible Conditions
  • Pulmonary Arterial Hypertension

SOTERIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 78 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 78 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 Blood Pressure
Change From Baseline in Body Weight
Change From Baseline in Electrocardiogram (ECG)
+7 more
Secondary outcome measures
Change From Baseline in 6-Minute Walk Distance (6MWD)
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
+4 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988
16%
Epistaxis
15%
COVID-19
8%
Telangiectasia
6%
Fatigue
6%
Headache
6%
Iron deficiency
5%
Urinary tract infection
5%
Thrombocytopenia
5%
Nausea
4%
Diarrhoea
4%
Dizziness
4%
Oedema peripheral
4%
Hypokalaemia
3%
Nasopharyngitis
3%
Rash
1%
Hepatic enzyme increased
1%
Flushing
1%
Atrial fibrillation
1%
Vascular device occlusion
1%
Acute coronary syndrome
1%
Acute myocardial infarction
1%
Abdominal pain upper
1%
Gastritis
1%
Complication associated with device
1%
Cholangitis acute
1%
Catheter site infection
1%
Pneumonia
1%
Septic shock
1%
Vascular device infection
1%
Haemarthrosis
1%
Acute kidney injury
1%
Interstitial lung disease
1%
Dyspnoea
1%
Cholecystitis
1%
Sarcoidosis
1%
Pain in extremity
1%
Acute respiratory distress syndrome
1%
Hypoxia
1%
Embolism venous
1%
Humerus fracture
1%
Haemorrhage intracranial
1%
Device occlusion
1%
Hyperthyroidism
1%
Gastrointestinal haemorrhage
1%
Drug hypersensitivity
1%
Gastroenteritis
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Placebo Plus Background PAH Therapy (LTDB Period)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

SOTERIA Trial Design

1Treatment groups
Experimental Treatment
Group I: Sotatercept TreatmentExperimental Treatment1 Intervention
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
2019
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,345 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,061 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
3,522 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,061 Patients Enrolled for Pulmonary Arterial Hypertension
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor
32 Previous Clinical Trials
3,522 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
1,061 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Pulmonary Arterial Hypertension Clinical Trial 2023: Sotatercept Treatment Highlights & Side Effects. Trial Name: NCT04796337 — Phase 3

Frequently Asked Questions

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

What is the target enrollment for this clinical trial?

"To meet the statistical power required to draw robust conclusions, 700 individuals that fit the study's inclusion criteria will be needed. The trial is being conducted by Acceleron Pharma Inc. at different locations, including Brigham and Womens Hospital in Boston, Massachusetts and Harbor UCLA Medical Center ( Site 1028) in Torrance, California."

Answered by AI

To what extent has sotatercept been studied in the past?

"Sotatercept is currently being researched in 4 trials, 3 of which are Phase 3 studies. Even though a large proportion of these clinical trials take place in Edmonton, Alberta, there are 492 research sites for sotatercept across the world"

Answered by AI

Is this a pioneering clinical trial?

"Sotatercept has been under investigation since 2021. After the first Phase 3 clinical trial, which was completed in that same year and sponsored by Acceleron Pharma Inc., sotatercept received drug approval. Currently, there are 4 active studies involving sotatercept being conducted in 182 cities across 28 countries."

Answered by AI

Are investigators looking for more participants in this experiment?

"Yes, this information is accurate. The trial was first posted on 5/12/2021 and was last updated on 10/28/2022. 37 different locations are needed to enroll the 700 planned participants."

Answered by AI

What are some possible adverse effects of sotatercept?

"Sotatercept was given a 3 on our safety scale at Power. This is because sotatercept is in Phase 3 trials, meaning that while there is data supporting efficacy, there are also multiple rounds of data supporting safety."

Answered by AI

How many different research facilities are coordinating this study?

"Currently, this clinical trial is taking place in Brigham and Womens Hospital (Boston, MA), Harbor UCLA Medical Center (Torrance, CA), University of Alberta Hospital (Edmonton, AB), as well as 37 other locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Kansas
Kentucky
What site did they apply to?
University of Kansas Medical Center
Medical University of South Carolina - PPDS
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My life style is going away fast. My Doctor said I should try this drug and a trail is the only way to get it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
2021. "A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04796337.
All > Arizona > Michigan
~414 spots leftby Sep 2027
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