Last updated on February 2019

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03496207

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Clinical Trial Manager

Baruch Padeh Poriya Medical Center
Tiberias, Israel
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Recruitment Status: Open

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