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Monoclonal Antibodies

REGN14256 for COVID-19

Phase 1
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 169
Awards & highlights

Summary

Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Injection-site Reactions (ISRs)
Severity of ISRs (Injection Site Reactions)
Severity of TEAEs
+2 more
Secondary outcome measures
Change From Baseline in Viral Load
Change From Baseline in Viral Load (Phase 1)
Concentrations of Imdevimab in Serum Over Time
+15 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: casirivimab + imdevimabExperimental Treatment2 Interventions
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Group II: REGN14256 + imdevimabExperimental Treatment2 Interventions
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1 Phase 3: (Open label) (≥12 and <18 Years)
Group III: REGN14256Experimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1
Group IV: PlaceboExperimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Group V: ImdevimabExperimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
637 Previous Clinical Trials
382,416 Total Patients Enrolled
13 Trials studying COVID-19
19,105 Patients Enrolled for COVID-19
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
271 Previous Clinical Trials
252,642 Total Patients Enrolled
10 Trials studying COVID-19
18,845 Patients Enrolled for COVID-19
~7 spots leftby Jul 2025