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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

More Information

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04519437
• Other Study ID Numbers: R10933-10987-HV-2093
• First Posted: August 19, 2020
• 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

• 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)