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

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

June 13, 2018

Primary Completion Date

March 9, 2022

Study Completion Date

March 9, 2022

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Placebo

Placebo

DRUG

Sotatercept

Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

OTHER

SOC

SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.

Trial Locations (43)

2010

St. Vincent's Hospital Sydney, Darlinghurst

2145

Westmead Hospital, Westmead

2305

John Hunter Hospital, New Lambton

4032

Prince Charles Hospital, Chermside

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda

29425

Medical University of South Carolina, Charleston

30430

Hospital Madre Teresa, Belo Horizonte

30625

Medizinische Hochschule Hannover, Hanover

32610

UF Health Shands Hospital, Gainesville

34295

Hôpital Arnaud de Villeneuve, Montpellier

34362

Lady Davis Carmel Medical Center, Haifa

38700

CHU Michallon, La Tronche

39008

Hospital Universitario Marques de Valdecilla, Santander

42055

Centre Hospitalier Universitaire de Saint Etienne, Saint-Etienne

45129

Lindner Clinical Trial Center, Cincinnati

48109

University of Michigan, Ann Arbor

49100

Rabin Medical Center - PPDS, Petah Tikva

52621

Chaim Sheba Medical Center, Ramat Gan

66160

University of Kansas Medical Center, Kansas City

77030

Houston Methodist Hospital, Houston

78278

Barzilai Medical Center, Ashkelon

80045

University of Colorado Hospital, Aurora

85006

Pulmonary Associates, PA, Phoenix

85012

Arizona Pulmonary Specialists, Phoenix

85381

Banner-University Medical Center Phoenix, Phoenix

85724

University of Arizona, Tucson

89010

Hospital Dia do Pulmão, Blumenau

90035

Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

94143

University of California, San Francisco Medical Center, San Francisco

94275

Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre

4428100

Meir Medical Center, Kefar Sava

05403-900

Instituto do Coracao - HCFMUSP, Cerqueira César

Hospital Sao Lucas da PUCRS, Jardim Botânico

04037

Hospital São Paulo, São Paulo

04103

Universitatsklinikum Leipzig, Leipzig

06120

Universitatsklinikum Halle (Saale), Halle

01307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

G81 4DY

Golden Jubilee National Hospital - PPDS, Clydebank

NW32QG

Royal Free London NHS Foundation Trust, London

W2 1NY

Imperial College Healthcare NHS Trust, London

All Listed Sponsors
lead

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY

NCT03496207 - A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) | Biotech Hunter | Biotech Hunter