Postural Orthostatic Tachycardia Syndrome (POTS)
Conditions
Keywords
Orthostatic intolerance
Brief summary
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) * How the study drug affects symptoms associated with POTS
Interventions
DRUGREGN7544
Subcutaneous (SC) administration
DRUGPlacebo
SC administration
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key 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 Key
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate (HR) from supine to standing (DeltaHR) | At Day 8 | — |
| Change from baseline in DeltaHR-avg | At day 29 | Only for Cohort B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through 90 Days | — |
| Severity of TEAEs | Through 90 Days | — |
| DeltaHR | 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) | At day 29 | Only for Cohort B |
Countries
Canada, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed