A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults with Pulmonary Arterial Hypertension
Phase 2 – studying effectiveness and dosage
Conditions:
Pulmonary Arterial Hypertension (PAH)
Sponsor: Regeneron Pharmaceuticals Inc.
trial.available_in:
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Overview
Trial status: Authorised
Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations, Change from baseline in mean pulmonary artery pressure, Change from baseline in cardiac output, Change from baseline in cardiac index, Change from baseline in right atrial pressure, Change from baseline in 6-Minute Walk Distance (6MWD), Concentrations of functional REGN13335 in plasma, Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma
Change from baseline in Pulmonary Vascular Resistance (PVR)
Description
Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations, Change from baseline in mean pulmonary artery pressure, Change from baseline in cardiac output, Change from baseline in cardiac index, Change from baseline in right atrial pressure, Change from baseline in 6-Minute Walk Distance (6MWD), Concentrations of functional REGN13335 in plasma, Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 47 participants
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