Peripheral Arterial DiseasePhase 2CLAUDIANCT06774040
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
A Phase 2 study testing Etribnabdione 25 mg BID and Etribnabdione 50 mg BID in people with Peripheral Arterial Disease, run by VivaCell Biotechnology España at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Etribnabdione 25 mg BID and Etribnabdione 50 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IIa Open Label, Dose-Finding, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease (PAD)
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Keywords
- Claudication, Arterial Occlusive Disease, Peripheral Artery Disease, Vascular Disease, Peripheral Vascular Disease, Chronic Limb Threatening Ischemia, Critical Limb Ischemia
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etribnabdione 25 mg BIDDrug
The trial will start with the lower dose. 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.
Etribnabdione 50 mg BIDDrug
The treatment will start when the regulatory authority, the sponsor and the site investigators have reviewed the low dose safety and pharmacokinetics data.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 25 mg BID Receives: Drug: Etribnabdione 25 mg BID |
| High dose | Experimental | 50 mg BID Receives: Drug: Etribnabdione 50 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
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.
Measured: 13 months
Secondary outcomes (6)
Vascularization
The angiogenesis induced by Etrinabdione treatment will be assessed by the evaluation of the peripheral arterial system of affected limbs by computed tomography angiography.
Measured: Baseline, 6 and 12 months
Absolute claudication time
The claudication time will be quantitatively measured by standardized treadmill test using a graded exercise protocol.
Measured: Baseline, 3, 6 and 12 months
Hemodynamic
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).
Measured: Baseline, 3, 6 and 12 months
Stenosis
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.
Measured: Baseline, 3, 6 and 12 months
Disease specific quality of life questionnaire (VascuQoL-6)
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.
Measured: Baseline, 3, 6 and 12 months
Tissue oxigenation
Measure the local oxygen released from the capillaries through the skin by transcutaneous oximetry.
Measured: Baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jan 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The trial 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VivaCell Biotechnology España
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774040
- Sponsor's protocol ID
- Etrinabdione-PAD02
- Acronym
- CLAUDIA
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia-Martin A, Prados ME, Lastres-Cubillo I, Ponce-Diaz FJ, Cerero L, Garrido-Rodriguez M, Navarrete C, Pineda R, Rodriguez AB, Munoz I, Moya J, Medeot A, Moreno JA, Chacon A, Garcia-Revillo J, Munoz E. Etrinabdione (VCE-004.8), a B55alpha activator, promotes angiogenesis and arteriogenesis in critical limb ischemia. J Transl Med. 2024 Nov 6;22(1):1003. doi: 10.1186/s12967-024-05748-w.
PubMed 39506809
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Open Label, Dose-Finding, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT06774040
- Acronym / sponsor ID
- CLAUDIA / Etrinabdione-PAD02
- Conditions
- Peripheral Arterial Disease
- Keywords
- Claudication, Arterial Occlusive Disease, Peripheral Artery Disease, Vascular Disease, Peripheral Vascular Disease, Chronic Limb Threatening Ischemia, Critical Limb Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VivaCell Biotechnology EspañaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial 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.
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Etribnabdione 25 mg BID25 mg BID |
| High dose | Experimental | Drug: Etribnabdione 50 mg BID50 mg BID |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etribnabdione 25 mg BIDThe trial will start with the lower dose. 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. | Drug | Low dose |
| Etribnabdione 50 mg BIDThe treatment will start when the regulatory authority, the sponsor and the site investigators have reviewed the low dose safety and pharmacokinetics data. | Drug | High dose |
Primary outcome
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: 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.
6 secondary outcomes
Vascularization
Time frame: Baseline, 6 and 12 months
Absolute claudication time
Time frame: Baseline, 3, 6 and 12 months
Hemodynamic
Time frame: Baseline, 3, 6 and 12 months
Stenosis
Time frame: Baseline, 3, 6 and 12 months
Disease specific quality of life questionnaire (VascuQoL-6)
Time frame: Baseline, 3, 6 and 12 months
Tissue oxigenation
Time frame: Baseline, 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 39506809Garcia-Martin A, Prados ME, Lastres-Cubillo I, Ponce-Diaz FJ, Cerero L, Garrido-Rodriguez M, Navarrete C, Pineda R, Rodriguez AB, Munoz I, Moya J, Medeot A, Moreno JA, Chacon A, Garcia-Revillo J, Munoz E. Etrinabdione (VCE-004.8), a B55alpha activator, promotes angiogenesis and arteriogenesis in critical limb ischemia. J Transl Med. 2024 Nov 6;22(1):1003. doi: 10.1186/s12967-024-05748-w.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etribnabdione 25 mg BID and Etribnabdione 50 mg BID in people with Peripheral Arterial Disease, run by VivaCell Biotechnology España at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.