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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат REGN13335
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol

Первичные конечные точки

• Change from baseline in Pulmonary Vascular Resistance (PVR) [Срок оценки: At week 24]

Вторичные конечные точки (10)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Through end of study, up to approximately 2.5 years]
• Severity of TEAEs [Срок оценки: 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 [Срок оценки: At week 24]
• Change from baseline in mean pulmonary artery pressure [Срок оценки: At week 24]
• Change from baseline in cardiac output [Срок оценки: At week 24]
• Change from baseline in cardiac index [Срок оценки: At week 24]
• Change from baseline in right atrial pressure [Срок оценки: At week 24]
• Change from baseline in 6-Minute Walk Distance (6MWD) [Срок оценки: At week 24]
• Concentrations of functional REGN13335 in plasma [Срок оценки: Through end of study, up to approximately 2.5 years]
• Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma [Срок оценки: Through end of study, up to approximately 2.5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

South Korea · 5 центров

• Gachon University Gil Medical Center — Namdong-gu
• Asan Medical Center — Seoul
• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• Samsung Medical Center — Seoul

Испания · 5 центров

• Hospital Vall d'Hebron — Barcelona
• Hospital Universitario Costa del Sol — Marbella
• Hospital Clinic, Barcelona — Barcelona
• University hospital 12 de octubre — Madrid
• University Hospital Salamanca — Salamanca

Германия · 3 центра

• Universitatsklinikum Halle — Halle
• Clinic of University Greifswald — Greifswald
• Universitatsmedizin Mainz — Mainz

Польша · 3 центра

• University Clinical Hospital in Poznan - Early Phase Unit — Poznan
• University Hospital in Bialystok — Bialystok
• Oddzial Kardiologiczny — Lodz

Австралия · 2 центра

• Mater Misericordiae Ltd — South Brisbane
• Royal Hobart Hospital — Hobart

Бельгия · 2 центра

• UZ Leuven — Leuven
• H.U.B. Erasme Hospital — Brussels

Великобритания · 2 центра

• Royal United Hospitals Bath NHS Foundation Trust — Bath
• Imperial College Healthcare NHS Trust, Hammersmith Hospital — London

США · 1 центр

• University of Colorado Denver — Aurora

Франция · 1 центр

• Hopital Bicetre — Le Kremlin-Bicêtre

Латвия · 1 центр

• P. Stradins Clinical University hospital — Riga

Идентификаторы

NCT: NCT07318597 · R13335-PAH-2365 · 2024-514754-79-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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