This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines. The study is looking at several other research questions, including: * What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Administered per the protocol
Administered per the protocol
University of Colorado Denver
Aurora, Colorado, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Nebraska Medical Center - 2365
Omaha, Nebraska, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
Change from baseline in Pulmonary Vascular Resistance (PVR)
Time frame: At week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through end of study, up to approximately 2.5 years
Severity of TEAEs
Time frame: Through end of study, up to approximately 2.5 years
Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations
Time frame: At week 24
Change from baseline in mean pulmonary artery pressure
Time frame: At week 24
Change from baseline in cardiac output
Time frame: At week 24
Change from baseline in cardiac index
Time frame: At week 24
Change from baseline in right atrial pressure
Time frame: At week 24
Change from baseline in 6-Minute Walk Distance (6MWD)
Time frame: At week 24
Concentrations of functional REGN13335 in plasma
Time frame: Through end of study, up to approximately 2.5 years
Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma
Time frame: Through end of study, up to approximately 2.5 years
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Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
RECRUITINGRoyal Hobart Hospital
Hobart, Tasmania, Australia
RECRUITINGUZ Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGH.U.B. Erasme Hospital
Brussels, Belgium
RECRUITINGHopital Bicetre
Le Kremlin-Bicêtre, France
RECRUITINGNouvel hopital civil
Strasbourg, France
RECRUITING...and 20 more locations