Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

Conditions

• Venus Leg Ulcers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EscharEx (EX-03) — DRUG
  a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area.
• Placebo (Gel vehicle) — DRUG
  A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area

Study Details

The main objective of this study is: To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.

Key Dates

Start date

Apr 30, 2025

Status verified

Oct 2024

Primary completion

Dec 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: EscharEx (EX-03)
  EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage
• Placebo Comparator: Placebo
  Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area Placebo powder, should be diluted with Water for Injection (WFI) prior usage
• Other: Collagenase
  Non-surgical standard of care treatment arm

Primary Outcome Measure

Incidence (number of patients) of target wound related AEs throughout the trial [ Time Frame: Throughout the study (week 2- week 15) ]

Central Contacts

• Shelly Vander, MSc
  +972 52 3527960
  [email protected]
• Keren David- Zarbiv, MSc
  +972 54 2233052
  [email protected]

Locations (1)

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