Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease

Phase 2

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Etribnabdione 25 mg BID; Drug: Etribnabdione 50 mg BID

• Registration Number: NCT06774040
• Lead Sponsor: VivaCell Biotechnology España

Brief Summary

The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione. The main questions it aims to answer are:

Has Etrinabdione an acceptable safety/tolerability profile during 12 months?

Do the patients show any improvement in any of the tests included in the protocol for this disease?

Researchers will test first the low dose of Etrinadione. If the product is safe at 3 months, the high dose can start.

Participants will:

Take Etrinabdione twice a day for 12 months. Visit the clinic once every 4 weeks for checkups and tests.

Detailed Description

This is a single center, open-label Phase IIa clinical study. The study will be conducted with 2 treatment arms 25 mg BID and 50 mg BID.

The study consists of a Screening Period, a Treatment Period, and a Follow-up Period. Total duration 14 months.

Subjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will start with the lower dose (25 mg BID). When the 12 patients have been treated for 3 months and the PK and safety data are evaluated by the regulatory authority, the Sponsor and the site investigators, the high dose (50 mg BID) will be released.

Study Timeline

• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-12
• Last Update Submitted: 2025-01-12
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-04-01
• Primary Completion: 2027-03
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Willing and able to provide informed consent and capable of understanding and complying with the protocol;
• Subjects classified as critical limb ischemia (CLI) Rutherford Category 2 or 3 (moderate or severe) claudication;
• Diabetes mellitus type 2 with HbA1c < 9%;
• In case of treatment for PAD, the subject is controlled on medical therapy indicated for CLI;
• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use a highly effective method of contraception;
• A male patient with a female partner of childbearing potential is eligible if he agrees to use acceptable method of contraception.

Exclusion Criteria

• Planned surgical or endovascular revascularization on the index leg within the next 12 months;
• Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening;
• Amputation at or above the talus on the index leg;
• Planned major amputation within the first month after screening;
• On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new treatments to the index leg during the trial;
• Uncontrolled or untreated proliferative retinopathy;
• Blood clotting disorder not caused by medication;
• Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure;
• Evidence of moderate to severe hepatocellular dysfunction;
• Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum;
• Subjects who may not be healthy enough to successfully complete all protocol requirements, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low dose	Etribnabdione 25 mg BID	25 mg BID
High dose	Etribnabdione 50 mg BID	50 mg BID

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)	13 months	This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.

Secondary Outcome Measures

Name	Time	Method
Stenosis	Baseline, 3, 6 and 12 months	Doppler ultrasound will be performed in the affected lower limbs at the level of the common femoral artery, superficial femoral artery, popliteal artery, posterior tibial artery and pedia artery.
Vascularization	Baseline, 6 and 12 months	The angiogenesis induced by Etrinabdione treatment will be assessed by the evaluation of the peripheral arterial system of affected limbs by computed tomography angiography.
Absolute claudication time	Baseline, 3, 6 and 12 months	The claudication time will be quantitatively measured by standardized treadmill test using a graded exercise protocol.
Hemodynamic	Baseline, 3, 6 and 12 months	The Ankle/Brachial Index (ABI) is a diagnostic measure used to assess blood flow and detect potential vascular abnormalities. It will be calculated as the ratio of systolic blood pressure at the ankle level (posterior tibial artery or pedia) divided by the systolic blood pressure obtained on the arm (humeral artery).
Disease specific quality of life questionnaire (VascuQoL-6)	Baseline, 3, 6 and 12 months	The questionnaire includes 6 questions with 4 possible answers, scoring from 1 to 4. The lower the score, the worse the patient's perceived quality of life.
Tissue oxigenation	Baseline, 3, 6 and 12 months	Measure the local oxygen released from the capillaries through the skin by transcutaneous oximetry.

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain