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This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS.
The aim of the study is to see how safe, tolerable, and effective the study drug is.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Randomized 1:1:1 |
|
| High Dose | Experimental | Randomized 1:1:1 |
|
| Matching Placebo | Placebo Comparator | Randomized 1:1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7544 | Drug | Subcutaneous (SC) administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate (HR) from supine to standing (DeltaHR) | At Day 8 | |
| Change from baseline in DeltaHR-avg | Only for Cohort B | At day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through 90 Days | |
| Severity of TEAEs | Through 90 Days | |
| DeltaHR |
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Key Inclusion Criteria:
Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
Has a body mass index between 18 and 35 kg/m2, inclusive
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | United States | ||
| North County Neurology Associates |
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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| Placebo | Drug | SC administration |
|
| At Day 15 and 29 |
| Supine HR | At Day 8, 15, and 29 |
| Standing HR | At Day 8, 15, and 29 |
| Supine blood pressure (BP) | At Day 8, 15, and 29 |
| Standing BP | At Day 8, 15, and 29 |
| Concentrations of REGN7544 in serum | Through 90 Days |
| Occurrence of anti-drug antibodies (ADAs) to REGN7544 | Through 90 Days |
| Magnitude of ADAs to REGN7544 | Through 90 Days |
| Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ) | Only for Cohort B | At day 29 |
| Carlsbad |
| California |
| 92011 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Southern California Heart Specialists | Pasadena | California | 91105 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Indiana University Health Neuroscience Center | Indianapolis | Indiana | 46202 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Saint Luke's MidAmerica Heart Institute | Kansas City | Missouri | 64111 | United States |
| New York University Langone | New York | New York | 10016 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D054971 | Orthostatic Intolerance |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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