← Back to Search

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

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

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 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

Injection site pain

Hypokalaemia

Rash

Flushing

Oedema peripheral

Thrombocytopenia

Nasopharyngitis

Urinary tract infection

Dyspnoea

Bronchitis

Fall

Pulmonary arterial hypertension

Iron deficiency

Inguinal hernia

Atrial flutter

Supraventricular tachycardia

Abdominal pain

Pancreatitis

Cellulitis

Pneumonia

Pneumonia influenzal

Respiratory tract infection

Sepsis

Upper respiratory tract infection

Osteoporotic fracture

Acute kidney injury

Haemoptysis

Pulmonary artery aneurysm

Upper gastrointestinal haemorrhage

Joint injury

Sjogren's syndrome

Cerebral haematoma

Device malfunction

Nephritis

Sarcoidosis

Gastroenteritis viral

100%

80%

60%

40%

20%

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