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Trial record 2 of 5 for:    Regeneron | Coronavirus

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

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ClinicalTrials.gov Identifier: NCT04519437
Recruitment Status : Active, not recruiting
First Posted : August 19, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Chronic Stable Illness Drug: REGN10933+REGN10987 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 974 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled 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
Actual Study Start Date : July 26, 2020
Estimated Primary Completion Date : October 25, 2021
Estimated Study Completion Date : October 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: REGN10933+REGN10987 Drug: REGN10933+REGN10987
Administered subcutaneous (SC) every 4 weeks (Q4W)

Placebo Comparator: Placebo Drug: Placebo
Administered subcutaneous (SC) every 4 weeks (Q4W)




Primary Outcome Measures :
  1. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Baseline ]
  2. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Day 29 ]
  3. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Day 57 ]
  4. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Day 85 ]
  5. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Day 113 ]
  6. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration [ Time Frame: Within 4 days postdose at Day 141 ]
  7. Concentrations of REGN10933 in serum over time [ Time Frame: Up to 52 weeks ]
  8. Concentrations of REGN10987 in serum over time [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Proportion of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
  2. Severity of TEAEs [ Time Frame: Up to 52 weeks ]
  3. Proportion of participants who achieve or exceed target concentration in serum of REGN10933 [ Time Frame: Up to 52 weeks ]
  4. Proportion of participants who achieve or exceed target concentration in serum of REGN10987 [ Time Frame: Up to 52 weeks ]
  5. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Up to 52 weeks ]
  6. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Up to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. 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
  2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening
  3. 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

Key Exclusion Criteria:

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

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519437


Locations
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United States, Arizona
Regeneron Study Site
Tempe, Arizona, United States, 85283
United States, Arkansas
Regeneron Study Site
Rogers, Arkansas, United States, 72758
United States, California
Regeneron Study Site
Sacramento, California, United States, 95864
United States, Florida
Regeneron Study Site
Miami, Florida, United States, 33014
United States, Nebraska
Regeneron Study Site
Lincoln, Nebraska, United States, 68502
United States, Ohio
Regeneron Study Site
Dayton, Ohio, United States, 45417
United States, Texas
Regeneron Study Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04519437    
Other Study ID Numbers: R10933-10987-HV-2093
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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).
URL: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)