UDONITRECTAG for Diabetic foot ulcer

Inclusion criteria

• {"criterion_text":"- Provision of signed and dated informed consent form;\n- Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study;\n- Glycated haemoglobin (HbA1c) levels <=10% (or <= 86 mmol/mol)\n- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;\n- For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n- Stated willingness to comply with all study procedures and availability for the duration of the study;\n- Male or female;\n- Age >=18 years;\n- Diagnosis of type 1 or 2 diabetes mellitus;\n- A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system and grading 1 in the PEDIS infection scale;\n- TpO2>= 30 mmHg or ABI (Ankle Brachial Index) >= 0.70;\n- Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline);\n- Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device;"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or Lactation. Female patients who are pregnant or breast-feeding;\n- Diagnosis of current of autoimmune disorders;\n- Immunosuppressed subjects;\n- History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration;\n- Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol);\n- Patients with ulcers due to other etiologies (e.g., arterial insufficiency);\n- Current use of high-dose steroids or immunosuppressants;\n- Febrile illness within one month from Visit 1b;\n- Current smoker;\n- Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30;\n- Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study.\n- Childbearing potential female patients who do not agree to use an acceptable method of contraception during the study, providing they are not pregnant or lactating;\n- Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination;\n- Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 1a o Visit 1b);\n- Severe renal failure defined as eGFR< 30 ml/min;\n- Clinical diagnosis of peripheral vascular disease (PVD) requiring a prompt revascularization;\n- Any surgery planned in the study period, including scheduled amputation at the ulcer site;\n- Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator’s judgment or presence of concurrent illness indicating a short life expectancy;\n- Diagnosis of current cancer;"}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability: I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events\n- II. Clinical laboratory results during and following udonitrectag administration\n- III. Pharmacokinetics","definition_or_measurement_approach":"I. Nature, frequency, severity and timing of adverse events (including skin irritation, haematological, hepatic, and renal events) as recorded during the study; II. Clinical laboratory results measured during and following udonitrectag administration; III. Pharmacokinetics as assessed per study PK assessments (pharmacokinetic profile) as described in the protocol."}

Secondary endpoints

• {"endpoint_text":"- Efficacy: percentage (number) of patients with ulcer achieving an area reduction of at least 50% from baseline during 6-week treatment. The percentage change area is defined as ((Area0 - Areat)/Area0)*100.","definition_or_measurement_approach":"Percentage (number) of patients achieving ≥50% ulcer area reduction from baseline during the 6-week treatment. Percentage change area defined as ((Area0 - Areat)/Area0)*100."}

Italy

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

25-09-2025

Processing Time Days

325

Number Of Sites

5

Number Of Participants

24

Primary sponsor

Full Name

Mimetech S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy