Clinical Trials Logo
NCT number NCT03496207
Study type Interventional
Source Acceleron Pharma, Inc.
Contact Clinical Trial Manager
Phone 617-649-9200
Email clinicaltrials011@acceleronpharma.com
Status Not yet recruiting
Phase Phase 2
Start date June 2018
Completion date November 2021

Clinical Trial Summary

Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 6 months in the double-blind Treatment Period, and then will be eligible to enroll into an 18-month Extension Period during which all participants will receive sotatercept. All treated patients will be also undergo follow-up period after last treatment.


Clinical Trial Description

This is a Phase 2, double blind, randomized, placebo-controlled, parallel-group study of sotatercept plus SOC versus placebo plus SOC in participants with PAH of WHO Group 1, functional class II-III.

Participants will be randomly assigned in a 1:1:1 ratio to receive sotatercept 0.3 mg/kg subcutaneously (SC) every 21 days, sotatercept 0.7 mg/kg SC every 21 days, or placebo every 21 days for a period of 24 weeks in the double-blind Treatment Period of the study while on standard of care therapy. Evaluations will include changes in pulmonary vascular resistance (PVR), six-minute-walk distance (6MWD), quality of life questionnaires, echocardiographic parameters, and safety. Participants who have not discontinued early from the Treatment Period and have had their post-Treatment Period PVR assessment will be eligible (per investigator assessment) to continue into the 18-month Extension Period in which sotatercept-treated participants will receive their latest dose level of sotatercept SC every 21 days and placebo-treated participants will be re-randomized 1:1 to receive sotatercept 0.3 mg/kg SC every 21 days or sotatercept 0.7 mg/kg SC every 21 days while on standard of care therapy.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Recruiting NCT01712620 - Spironolactone for Pulmonary Arterial Hypertension Phase 1/Phase 2
Recruiting NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Not yet recruiting NCT02845518 - Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA) N/A
Recruiting NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01847014 - Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument Phase 3
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Recruiting NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00709098 - Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension Phase 3
Completed NCT00741819 - Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects Phase 4
Completed NCT00323297 - Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension Phase 4