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Purpose

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: - How the study drug changes heart rate and blood pressure in participants with POTS - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening: 1. Increase in HR ≥30 beats per minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol 2. Absence of orthostatic hypotension, defined as a decrease in systolic blood pressure (SBP) >20 mm Hg within 3 minutes of standing 3. Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol 4. Ongoing episodic symptoms consistent with POTS (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months 2. During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS) 3. Has a body mass index between 18 and 35 kg/m2, inclusive

Exclusion Criteria

  1. History of hypertension or a seated SBP during screening that is >140 mm Hg 2. SBP during active stand (AS) test during screening, either supine or standing, that is >140 mm Hg systolic on ≥2 measurements 3. Increase in HR <20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol 4. Is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ECG) performed during screening period 5. Is confined to bed more than 50% of waking hours 6. Within 5 days of screening visit has used medications with direct effects on blood volume, BP, or HR (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (IV) saline) NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low Dose 		Randomized 1:1:1
  • Drug: REGN7544
    Subcutaneous (SC) administration
Experimental
High Dose 		Randomized 1:1:1
  • Drug: REGN7544
    Subcutaneous (SC) administration
Placebo Comparator
Matching Placebo 		Randomized 1:1:1
  • Drug: Placebo
    SC administration

Recruiting Locations

Mercy Gilbert Medical Center
Gilbert 5295903, Arizona 5551752 85297

North County Neurology Associates
Carlsbad 5334223, California 5332921 92011

Stanford University
Palo Alto 5380748, California 5332921 94303

Southern California Heart Specialists
Pasadena 5381396, California 5332921 91105

Yale University
New Haven 4839366, Connecticut 4831725 06511

Innovative Research of West Florida, Inc.
Clearwater 4151316, Florida 4155751 33756

Indiana University Health Neuroscience Center
Indianapolis 4259418, Indiana 4921868 46202

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Saint Luke's MidAmerica Heart Institute
Kansas City 4393217, Missouri 4398678 64111

New York University Langone
New York 5128581, New York 5128638 10016

Columbia University
New York 5128581, New York 5128638 10032

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

University of Texas Southwestern
Dallas 4684888, Texas 4736286 753908565

University of Utah
Salt Lake City 5780993, Utah 5549030 84108

More Details

NCT ID
NCT06593600
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center