Assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pharmazz EU Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

21 Aug 2025 → ongoing

Decision date (initial)

2025-06-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pharmazz Inc.

External identifiers

EU CT number

2024-519551-29-00

ClinicalTrials.gov

NCT05691244

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To determine whether sovateltide causes a good functional outcome in patients with acute cerebral ischemic stroke assessed by modified Rankin Scale (mRS) score of 0-2 at day 90 post-randomization.

Secondary objectives 10

1. To determine whether sovateltide causes a good functional outcome in patients with acute cerebral ischemic stroke assessed by the National Institute of Health Stroke Scale (NIHSS) score of <6 at day 90 post-randomization.
2. A good functional outcome in patients with acute cerebral ischemic stroke assessed by the Barthel Index (BI) score of ≥90 at day 90 post-randomization.
3. An excellent functional outcome in patients with acute cerebral ischemic stroke assessed by a modified Rankin Scale score of 0-1 at day 90 post-randomization.
4. Change in Quality-of-life (QoL) as assessed by EuroQol-EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at days 30, 60, and 90 post-randomization.
5. Incidence of recurrent cerebral ischemic stroke within 90 days post-randomization
6. Incidence of mortality within 90 days post-randomization.
7. Incidence of symptomatic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization
8. Incidence of radiographic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization.
9. Alteration in cognition at days 30 and 90 measured by Montreal Cognitive Assessment (MoCA) Test.
10. Any adverse events (AE) or serious adverse events (SAEs) are associated with sovateltide.

Conditions and MedDRA coding

Acute cerebral ischemic stroke

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adult males or females aged 18 – 80 years of age
2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures
3. A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20, NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.
5. The patient is <24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal
6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits

Exclusion criteria 7

1. Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
2. Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2)
3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH) on the baseline CT or MRI scan
4. Known pregnancy and lactating women
5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator’s opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study
6. Concurrent participation in any other therapeutic clinical trial
7. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint of the study is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale score of 0-2 on day 90 post-randomization.

Secondary endpoints 10

1. The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 90 post-randomization.
2. The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization.
3. The proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with a modified Rankin Scale score of 0-1 on day 90 post-randomization.
4. Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization.
5. The proportion of patients with recurrent ischemic stroke within 90 days post-randomization.
6. Number of deaths within day 90 post-randomization.
7. The proportion of patients with symptomatic ICH within 24 (± 6) hours of randomization.
8. The proportion of patients with radiographic ICH within 24 (± 6) hours of randomization.
9. Change in MoCA score at days 30 and 90 post-randomization.
10. The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pharmazz EU Limited

Sponsor organisation

Pharmazz EU Limited

Address

The Black Church, Saint Mary's Place North Saint Mary's Place North

City

Dublin 7

Postcode

D07 P4AX

Country

Ireland

Scientific contact point

Organisation

Pharmazz EU Limited

Contact name

Prof. Anil Gulati

Public contact point

Organisation

Pharmazz EU Limited

Contact name

Prof. Anil Gulati

Third parties 5

Locations

2 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 33 files

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

Application history

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