A011-09: A Phase 2 Study of Sotatercept for the Treatment of PAH
Research type
Research Study
Full title
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
IRAS ID
245412
Contact name
Luke Howard
Contact email
Sponsor organisation
Acceleron Pharma Inc.
Eudract number
2017-004738-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
136150, IND
Duration of Study in the UK
2 years, 8 months, 8 days
Research summary
Research Summary
Pulmonary arterial hypertension (PAH) is a disease affecting the blood vessels of the lung. PAH leads to narrowing of the blood vessels from the heart to the lung which increases pressure and strain on the heart. There is currently no cure for PAH but medications can reduce symptoms and help manage the condition.
Sotatercept is being evaluated to determine if taking it in combination with drugs commonly used to treat PAH can help reduce the heart pressures and improve symptoms of PAH.
The study starts with a 28-day screening period. Eligible patients will then enter double-blind treatment period. Patients will have 33% chance of receiving 0.3mg/kg sotatercept, 0.7mg/kg sotatercept, or placebo. Sotatercept or placebo will be injected under the skin every 3 weeks and patients will continue their current PAH medications. This study period will last approximately 6 months and involve 10 clinic visits.
After the double-blind treatment period, patients may be eligible to enter the extension period. Patients who were previously on sotatercept will continue with the same dose. Patients who were previously on placebo will have 50% chance of receiving 0.3 mg/kg sotatercept or 0.7 mg/kg sotatercept. Dosing will be every 3 weeks and patients will continue their current PAH medications. This period of the study will last 18 months and involve 28 clinic visits. Following the completion of the double-blind treatment period or extension period (as applicable), patients will enter a follow-up period that lasts approximately 8 weeks and involves 2 clinic visits.
Procedures conducted during the study include physical examinations, vital signs, blood testing, ECGs, ECHOs, right heart catheterisation, 6-minute walk test and completion of quality of life questionnaires.
This study is sponsored by Acceleron Pharma Inc. Approximately 90 patients will participate in this study worldwide with 8 patients from 4 hospitals in the UK.
Summary of Results
The Phase 2 PULSAR trial evaluated the safety and efficacy of sotatercept for adults with pulmonary arterial hypertension. Results of the PULSAR Phase 2 study showed that sotatercept added to approved therapy improved the primary endpoint of reduction in in pulmonary vascular resistance in patients with pulmonary arterial hypertension, as well as improvement in six-minute walk distance and secondary efficacy outcome measures.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1461
Date of REC Opinion
18 Oct 2018
REC opinion
Further Information Favourable Opinion