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
Outcome
Mixed primary results
registry analysis (superiority test); Placebo vs Sotatercept 0.3 mg/kg; p = 0.0030; Difference in Least Squares Means -151.1 (95% CI -249.59 to -52.63); ANCOVA NCT03496207 ↗
registry analysis (superiority test); Placebo-Crossed Treatment Group vs Continued Sotatercept Treatment Group; p = 0.7851; Difference in Least Squares Means -13.9 (95% CI -113.85 to 86.06); ANCOVA NCT03496207 ↗
registry analysis (superiority test); Placebo-Crossed Treatment Group; p <.0001; Multiple Imputation Mean Difference -223.2 (95% CI -335.83 to -110.49); ANCOVA; note: Comparison of baseline and final value NCT03496207 ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotatercept | Protein / enzyme biologic | 0.3 mg/kg | Subcutaneous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.7 mg/kg | Subcutaneous |