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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514754-79-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBTP-Arm1 | Experimental |
| |
| DBTP-Arm2 | Experimental |
| |
| DBTP-Arm3 | Placebo Comparator |
| |
| OLE-Arm1 | Experimental |
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| OLE-Arm2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN13335 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Pulmonary Vascular Resistance (PVR) | At week 24 |
| Measure | Description | 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 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States | |
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| Label | URL |
|---|---|
| Illuminate | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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The study will include: A Double-Blind Treatment Period (DBTP) and an Open-Label Extension (OLE) period for participants who choose to continue treatment
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| Placebo | Drug | Administered per the protocol |
|
| 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 |
| Royal Hobart Hospital |
| Recruiting |
| Hobart |
| Tasmania |
| 7000 |
| Australia |
| Hopital Bicetre | Recruiting | Le Kremlin-BicĂȘtre | 94275 | France |
| P. Stradins Clinical University hospital | Recruiting | Riga | LV1002 | Latvia |
| Gachon University Gil Medical Center | Recruiting | Namdong-gu | Incheon | 21565 | South Korea |
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hospital Universitario Costa del Sol | Recruiting | Marbella | Malaga | 29603 | Spain |
| Imperial College Healthcare NHS Trust, Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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