Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 24, 2020
First Posted Date  ICMJE August 19, 2020
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE July 26, 2020
Estimated Primary Completion Date October 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Concentrations of REGN10933 in serum over time [ Time Frame: Up to 52 weeks ]
  • Concentrations of REGN10987 in serum over time [ Time Frame: Up to 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Concentrations of REGN10933 in serum over time [ Time Frame: Up to 44 weeks ]
  • Concentrations of REGN10987 in serum over time [ Time Frame: Up to 44 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Proportion of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
  • Severity of TEAEs [ Time Frame: Up to 52 weeks ]
  • Proportion of participants who achieve or exceed target concentration in serum of REGN10933 [ Time Frame: Up to 52 weeks ]
  • Proportion of participants who achieve or exceed target concentration in serum of REGN10987 [ Time Frame: Up to 52 weeks ]
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Up to 52 weeks ]
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Up to 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Proportion of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 44 weeks ]
  • Severity of TEAEs [ Time Frame: Up to 44 weeks ]
  • Proportion of participants who achieve or exceed target concentration in serum of REGN10933 [ Time Frame: Up to 44 weeks ]
  • Proportion of participants who achieve or exceed target concentration in serum of REGN10987 [ Time Frame: Up to 44 weeks ]
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 [ Time Frame: Up to 44 weeks ]
  • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 [ Time Frame: Up to 44 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Chronic Stable Illness
Intervention  ICMJE
  • Drug: REGN10933+REGN10987
    Administered subcutaneous (SC) every 4 weeks (Q4W)
  • Drug: Placebo
    Administered subcutaneous (SC) every 4 weeks (Q4W)
Study Arms  ICMJE
  • Experimental: REGN10933+REGN10987
    Intervention: Drug: REGN10933+REGN10987
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 1, 2020)
974
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2020)
420
Estimated Study Completion Date  ICMJE October 25, 2021
Estimated Primary Completion Date October 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04519437
Other Study ID Numbers  ICMJE R10933-10987-HV-2093
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP