Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Official Title

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Details

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period. In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.

As of protocol amendment 6, the 18-month Extension Period is being removed. Participants who have completed at least the 24-week placebo controlled treatment period and the end of study visit, and who have not discontinued study treatment early, may be eligible to participate in an extension study.

Keywords

Hypertension, Pulmonary, Pulmonary, hypertension, Cpc PH, HFpEF, sotatercept, Pulmonary Hypertension, Hypertension, Sotatercept 0.3 mg/kg, Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg, Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg

Eligibility

Locations

  • University of California Irvine ( Site 1086)
    Orange California 92868 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
    Torrance California 90502 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT04945460
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated