drugset
drugset / Trial / NCT04411199

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

NCT04411199 ↗

Phase 3 Completed 975 enrolled PolyPid Ltd.
RandomizedParallel-groupTriple-blindPrevention

Summary

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

Timeline

Start
2020-12-15
Primary completion
2025-04-14
Completion
2025-05-10

Outcome

Met primary endpoint

registry analysis (superiority test); D-PLEX + Standard of Care (SoC) vs Standard of Care (SoC); p = 0.0039; Risk Difference (RD) -7.2 (95% CI -12.1 to -2.3) NCT04411199 ↗

release “The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints.” polypid.com ↗

release “In the Phase 3 SHIELD II trial, D-PLEX 100 met its primary endpoint and key secondary endpoints” polypid.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule — Other

Indications

No indication recorded.