Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN13335, Placebo.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, France, Germany +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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)
Interventions
- Drug REGN13335
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Change from baseline in Pulmonary Vascular Resistance (PVR) [Time frame: At week 24]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 5 centers
- Gachon University Gil Medical Center — Namdong-gu
- Asan Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
- Samsung Medical Center — Seoul
Spain · 5 centers
- 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
Germany · 3 centers
- Universitatsklinikum Halle — Halle
- Clinic of University Greifswald — Greifswald
- Universitatsmedizin Mainz — Mainz
Poland · 3 centers
- University Clinical Hospital in Poznan - Early Phase Unit — Poznan
- University Hospital in Bialystok — Bialystok
- Oddzial Kardiologiczny — Lodz
Australia · 2 centers
- Mater Misericordiae Ltd — South Brisbane
- Royal Hobart Hospital — Hobart
Belgium · 2 centers
- UZ Leuven — Leuven
- H.U.B. Erasme Hospital — Brussels
United Kingdom · 2 centers
- Royal United Hospitals Bath NHS Foundation Trust — Bath
- Imperial College Healthcare NHS Trust, Hammersmith Hospital — London
United States · 1 center
- University of Colorado Denver — Aurora
France · 1 center
- Hopital Bicetre — Le Kremlin-Bicêtre
Latvia · 1 center
- P. Stradins Clinical University hospital — Riga
Identifiers
NCT: NCT07318597 · R13335-PAH-2365 · 2024-514754-79-00