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

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 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.

Timeline

Start

2018-06-13

Primary completion

2022-03-09

Completion

2022-03-09

Publications

• Results Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Ghofrani HA, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, de Oliveira Pena J, Badesch DB. Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Eur Respir J. 2023 Jan 6;61(1):2201347. doi: 10.1183/13993003.01347-2022. Print 2023 Jan.
• Dutta S, Shah R, Singhal S, Singh M, Dholariya S, Chawla S, Katoch C. A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension. Expert Opin Drug Saf. 2026 Jun 9:1-13. doi: 10.1080/14740338.2026.2685360. Online ahead of print.
• Montani D, McLaughlin VV, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Escribano Subias P, Feldman J, Meyer GM, Olsson KM, Coulet F, Manimaran S, Zhao Y, Lau A, de Oliveira Pena J, Badesch DB, Humbert M. Consistent Safety and Efficacy of Sotatercept for Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers and Noncarriers: A Planned Analysis of a Phase II, Double-Blind, Placebo-controlled Clinical Trial (PULSAR). Am J Respir Crit Care Med. 2025 Jun;211(6):1028-1037. doi: 10.1164/rccm.202409-1698OC.
• Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.

Drugs

Indications