Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

NCT04519437 | Completed Phase 1 FDA Drug

• 1 other identifier: R10933-10987-HV-2093
• Study Type: interventional
• Target: 974
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objectives are:

• To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
• To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are:
• To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
• To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
• To assess the immunogenicity of REGN10933 and REGN10987

Conditions

Healthy; Chronic Stable Illness

Keywords

Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Baseline

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Day 29

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Day 57

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Day 85

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Day 113

• Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

  Within 4 days postdose at Day 141

• Concentrations of REGN10933 in serum over time

  Up to 52 weeks

• Concentrations of REGN10987 in serum over time

  Up to 52 weeks

Secondary Outcomes (6)

• Proportion of participants with treatment-emergent adverse events (TEAEs)

  Up to 52 weeks

• Severity of TEAEs

  Up to 52 weeks

• Proportion of participants who achieve or exceed target concentration in serum of REGN10933

  Up to 52 weeks

• Proportion of participants who achieve or exceed target concentration in serum of REGN10987

  Up to 52 weeks

• Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933

  Up to 52 weeks

Study Arms (2)

REGN10933+REGN10987

EXPERIMENTAL

Drug: REGN10933+REGN10987

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN10933+REGN10987 DRUG

Administered subcutaneous (SC) every 4 weeks (Q4W)

Also known as: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™, Ronapreve™

REGN10933+REGN10987

Placebo DRUG

Administered subcutaneous (SC) every 4 weeks (Q4W)

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
• Stable medication for co-morbid condition(s) for at least 6 months prior to screening
• Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

You may not qualify if:

• Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
• Subject-reported clinical history of COVID-19 as determined by investigator
• Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
• Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
• Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
• Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
• Received investigational or approved SARS-CoV-2 vaccine
• Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
• Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (7)

Regeneron Study Site

Tempe, Arizona, 85283, United States

Location

Regeneron Study Site

Rogers, Arkansas, 72758, United States

Location

Regeneron Study Site

Sacramento, California, 95864, United States

Location

Regeneron Study Site

Miami, Florida, 33014, United States

Location

Regeneron Study Site

Lincoln, Nebraska, 68502, United States

Location

Regeneron Study Site

Dayton, Ohio, 45417, United States

Location

Regeneron Study Site

Austin, Texas, 78705, United States

Location

Related Publications (2)

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

casirivimab and imdevimab drug combination; casirivimab; imdevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 19, 2020
• Study Start: July 26, 2020
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

US (7)