Pulmonary Arterial Hypertension (PAH)
Conditions
Keywords
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH), Elevated Pulmonary Vascular Resistance (PVR), World Health Organization (WHO) functional class II or III, Platelet-Derived Growth Factor-B (PDGF-B), REGN13335
Brief 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)
Interventions
DRUGREGN13335
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study will include: A Double-Blind Treatment Period (DBTP) and an Open-Label Extension (OLE) period for participants who choose to continue treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. 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 4. PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period 5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key
Exclusion criteria
1. 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 2. Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period 3. History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol 4. 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 5. Evidence of interstitial lung disease as defined in the protocol 6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol 7. Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol 8. Has any history of intracranial bleeding or any history of elevated intracranial pressure 9. Has any history of bleeding meeting criteria as described in the protocol Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Pulmonary Vascular Resistance (PVR) | At week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through end of study, up to approximately 2.5 years |
| Severity of TEAEs | 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 | At week 24 |
| Change from baseline in mean pulmonary artery pressure | At week 24 |
| Change from baseline in cardiac output | At week 24 |
| Change from baseline in cardiac index | At week 24 |
| Change from baseline in right atrial pressure | At week 24 |
| Change from baseline in 6-Minute Walk Distance (6MWD) | At week 24 |
| Concentrations of functional REGN13335 in plasma | Through end of study, up to approximately 2.5 years |
| Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma | Through end of study, up to approximately 2.5 years |
Countries
Australia, Belgium, France, Germany, Latvia, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed