← Back to Search

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
Females of childbearing potential must have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
Females of childbearing potential must refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 78 months
Awards & highlights

SOTERIA Trial Summary

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

Who is the study for?
This trial is for adults with Pulmonary Arterial Hypertension who've completed previous sotatercept studies without early discontinuation. Participants must agree to contraception and not donate blood or sperm. They can't join if they missed more than 4 doses between studies, have ongoing serious side effects from prior sotatercept trials, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of a drug called Sotatercept in patients with PAH when added to their current treatment regimen. It's an open-label follow-up to earlier phases where Sotatercept showed promise in improving heart and lung function.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions given that it's a study focusing on the long-term safety and tolerability of Sotatercept as part of PAH therapy.

SOTERIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use and will continue to use effective birth control and a barrier method during the study.
Select...
I agree not to breastfeed or donate eggs/blood for 16 weeks after the last study drug dose.
Select...
I agree to use specified condoms during the study and for 16 weeks after, even if I've had a vasectomy.
Select...
I am not pregnant and agree to regular pregnancy tests during and up to 8 weeks after the study.
Select...
I will not donate blood or sperm during and for 4 months after the study.
Select...
I can understand and agree to the study's terms.

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
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%
Fall
1%
Inguinal hernia
1%
Iron deficiency
1%
Atrial flutter
1%
Bronchitis
1%
Pulmonary arterial hypertension
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 (LTDB Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)

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
3,567 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
3,567 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
~387 spots leftby Sep 2027