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Clinical Trials/2024-514946-35-00
2024-514946-35-00
Recruiting
Phase 2

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients with Sepsis-Induced Hypotension

Regeneron Pharmaceuticals Inc.11 sites in 1 country31 target enrollmentStarted: February 19, 2025Last updated:
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Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals Inc.
Enrollment
31
Locations
11
Primary Endpoint
Cumulative vasopressor dose.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the effect of REGN7544 on vasopressor requirements in participants with sepsis-induced hypotension.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period.
  • •Sepsis-induced hypotension that has not responded to intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol.
  • •Other protocol defined inclusion criteria apply.

Exclusion Criteria

  • •Unable to obtain informed consent by participant or Legally Authorized Representative (LAR).
  • •Other protocol-defined exclusion criteria apply.
  • •Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
  • •Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest.
  • •Ejection fraction <20% in the most recent known echocardiogram.
  • •Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization.
  • •History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months.
  • •Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol.
  • •Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration.
  • •Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.

Outcomes

Primary Outcomes

Cumulative vasopressor dose.

Cumulative vasopressor dose.

Secondary Outcomes

  • Magnitude of ADA to REGN7544.
  • Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs).
  • Time-weighted average mean arterial pressure (MAP).
  • Change in MAP.
  • Proportion of surviving participants free of vasopressor(s).
  • Cumulative net fluid balance.
  • Cumulative urine output.
  • Cumulative fluid intake.
  • Concentrations of REGN7544 in serum.
  • Incidence of anti-drug antibodies (ADA) to REGN7544.

Investigators

Sponsor
Regeneron Pharmaceuticals Inc.
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Medical Affairs

Scientific

Regeneron Pharmaceuticals Inc.

Study Sites (11)

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