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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
Pivotal Trial
Summary
This trial is testing a new medication called sotatercept to help adults with high blood pressure in their lungs. The goal is to see if it helps them walk longer distances after several months of treatment. All participants are already receiving other treatments for their condition.
Eligible Conditions
- Pulmonary Arterial Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2022 Phase 3 trial • 324 Patients • NCT0457698820%
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%
Iron deficiency
1%
Pulmonary arterial hypertension
1%
Bronchitis
1%
Inguinal hernia
1%
Atrial flutter
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)
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~690
Background PAH Therapy
2021
Completed Phase 3
~330
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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
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