NCT05648110

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,882 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 130 Years
• Healthy volunteers: Accepted

Summary

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

Detailed description

In the Parent study, the Phase I Sentinel Safety Cohort will assess the safety of AZD5156 (a combination of 2 mAbs, AZD1061 \[cilgavimab, a component of AZD7442 (EVUSHELD)\] and AZD3152) in healthy adults and the Phase III Main Cohort will assess the safety, efficacy, PK, and neutralizing activity of two doses of AZD3152 compared with two doses of comparator given at a 6-month interval in adults and adolescents 12 years of age or older (weighing at least 40 kg) with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at higher risk of developing severe COVID-19 in 18 countries. Sub-study: This Phase II sub-study of SUPERNOVA is operating in USA only, and it will assess the safety, PK, and predicted neutralizing activity of AZD3152 in adults 18 years of age or older (weighing at least 40 kg) with conditions causing immune impairment who are less likely to mount an adequate protective immune response after vaccination as well as individuals who are immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Conditions

• COVID-19, SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	AZD5156 (Parent study Sentinel Safety Cohort)	600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL 3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
BIOLOGICAL	Placebo (Parent study Sentinel Safety Cohort)	single dose of Placebo (3 mL + 2 mL) IM
BIOLOGICAL	EVUSHELD™ (Parent study Main Cohort)	600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL 2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181
BIOLOGICAL	AZD3152 (Parent study Main Cohort)	300 mg AZD3152 at 150 mg/mL 1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181
BIOLOGICAL	Placebo (Parent study Main Cohort)	Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181
BIOLOGICAL	AZD3152 (Sub-study)	Single dose of 1200 mg IV at Visit 1 Day 1
BIOLOGICAL	AZD7442 - EVUSHELD™ (Sub-study)	Single dose 300 mg IM administered on Visit 1 Day 1
BIOLOGICAL	AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152	Single dose of AZD7442 (EVUSHELD™) 300 mg IM

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-03-29
• Completion: 2025-02-11
• First posted: 2022-12-13
• Last updated: 2025-03-13

Locations

215 sites across 18 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Israel, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study