drugset / Trial / NCT02148705

A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Phase 3 Completed 175 enrolled MediWound Ltd

RandomizedFactorialSingle-blindTreatment

Summary

This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.

Timeline

Start: 2015-05-27
Primary completion: 2018-06-12
Completion: 2020-08-20

Outcome

Met primary endpoint

paper Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). PMID 37715999 ↗

registry NexoBrid Gel vs Gel Vehicle; p <0.0001; Odds Ratio (OR) 288.281 (95% CI 35.549 to 13984.356); Fisher Exact NCT02148705 ↗

release “met its primary and all secondary endpoints in its pivotal U.S. Phase 3 clinical study (DETECT) with NexoBrid” mediwound.com ↗

release “robust top-line results from our Phase 3 DETECT study of NexoBrid, in which we met primary and all secondary endpoints” mediwound.com ↗

release “The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile.” mediwound.com ↗

release “DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30% of total body surface area met its primary endpoint” mediwound.com ↗

release “met its primary endpoint of complete eschar removal compared to gel vehicle” mediwound.com ↗

Publications

Shoham Y, Rosenberg L, Hickerson W, Goverman J, Iyer N, Barrera-Oro J, Lipovy B, Monstrey S, Blome-Eberwein S, Wibbenmeyer LA, Scharpenberg M, Singer AJ. Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial. J Burn Care Res. 2024 Mar 4;45(2):297-307. doi: 10.1093/jbcr/irad142.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	anacaulase-bcdb	Protein / enzyme biologic	2 g	Topical

Indications

No indication recorded.