RecruitingPhase 2NCT07318597

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

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

Sponsor

Regeneron Pharmaceuticals

Enrollment

99 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension PAH

Summary

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
WHO functional class II or III (slight to marked limitation of functional status due to PAH)
Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol
PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol

Exclusion Criteria9

Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or multifactorial mechanisms) PH according to the 7th WSPH
Pulmonary Arterial Wedge Pressure (PAWP) >15 mm Hg by RHC during the screening period
History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity <0.7 and FEV1 <70% of the predicted value as described in the protocol
Evidence of interstitial lung disease as defined in the protocol
Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
Has any history of intracranial bleeding or any history of elevated intracranial pressure
Has any history of bleeding meeting criteria as described in the protocol