NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mimetech S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-01-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

MimeTech R.r.l.

External identifiers

EU CT number

2024-519405-35-00

EudraCT number

2021-002212-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To determine the safety, tolerability, and pharmacokinetic profile of udonitrectag (MT8) added to standard of care versus
standard of care alone in the treatment of Diabetic Foot Ulcers.

Secondary objectives 1

1. To determine and to compare the ability of two doses of udonitrectag in promoting reduction of the ulcer area during 6-week treatment.

Conditions and MedDRA coding

Diabetic Foot Ulcer

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Provision of signed and dated informed consent form;
2. Stated willingness to comply with all study procedures and availability for the duration of the study;
3. Male or female;
4. Age >=18 years;
5. Diagnosis of type 1 or 2 diabetes mellitus;
6. A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system and grading 1 in the PEDIS infection scale;
7. TpO2>= 30 mmHg or ABI (Ankle Brachial Index) >= 0.70;
8. Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline);
9. Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device;
10. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study;
11. Glycated haemoglobin (HbA1c) levels <=10% (or <= 86 mmol/mol)
12. 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;
13. For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion criteria 19

1. Pregnancy or Lactation. Female patients who are pregnant or breast-feeding;
2. 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;
3. Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination;
4. 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);
5. Severe renal failure defined as eGFR< 30 ml/min;
6. Clinical diagnosis of peripheral vascular disease (PVD) requiring a prompt revascularization;
7. Any surgery planned in the study period, including scheduled amputation at the ulcer site;
8. 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;
9. Diagnosis of current cancer;
10. Diagnosis of current of autoimmune disorders;
11. Immunosuppressed subjects;
12. 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;
13. Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol);
14. Patients with ulcers due to other etiologies (e.g., arterial insufficiency);
15. Current use of high-dose steroids or immunosuppressants;
16. Febrile illness within one month from Visit 1b;
17. Current smoker;
18. Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30;
19. Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Safety and tolerability: I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events
2. II. Clinical laboratory results during and following udonitrectag administration
3. III. Pharmacokinetics

Secondary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mimetech S.r.l.

Sponsor organisation

Mimetech S.r.l.

Address

Via Della Cernaia 21

City

Florence

Postcode

50129

Country

Italy

Scientific contact point

Organisation

Mimetech S.r.l.

Contact name

Federico Cozzolino

Public contact point

Organisation

Mimetech S.r.l.

Contact name

Federico Cozzolino

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications