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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514754-79-00
Enrollment
5
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Brief summary

Change from baseline in Pulmonary Vascular Resistance (PVR)

Detailed 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

Interventions

DRUGPlacebo to REGN13335

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in Pulmonary Vascular Resistance (PVR)

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 19, 2026