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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
974
Administered subcutaneous (SC) every 4 weeks (Q4W)
Administered subcutaneous (SC) every 4 weeks (Q4W)
Regeneron Study Site
Tempe, Arizona, United States
Regeneron Study Site
Rogers, Arkansas, United States
Regeneron Study Site
Sacramento, California, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Lincoln, Nebraska, United States
Regeneron Study Site
Dayton, Ohio, United States
Regeneron Study Site
Austin, Texas, United States
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
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
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