Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
12
Countries
1
Sites
2
Arterial Ischaemic Stroke (AIS)
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
Key facts
- Sponsor
- Clinuvel Europe Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 10 Mar 2023 → 19 Nov 2024
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- CLINUVEL EUROPE LIMITED
External identifiers
- EU CT number
- 2022-500919-40-01
- EudraCT number
- 2021-006126-52
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
Secondary objectives 3
- Evaluate the impact of afamelanotide on neurological functions in patients with acute Arterial Ischaemic Stroke (AIS) using the National Institutes of Health Stroke Scale (NIHSS).
- Identify changes in reperfusion of the ischaemic penumbra in AIS patients, specifically the ischaemic core and/ or the penumbral ischaemic zone (salvageable tissue), following treatment with afamelanotide.
- Assess cognitive functions and activities of daily living in AIS patients following treatment with afamelanotide.
Conditions and MedDRA coding
Arterial Ischaemic Stroke (AIS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10061256 | Ischaemic stroke | 100000004852 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500919-40-00 | A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT) | Clinuvel Europe Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Male or female subjects with a diagnosis of first AIS
- Six patients mild to moderate stroke severity and six patients moderate to severe stroke severity
- At least three patients with an NIHSS score of 1-15 and at least three patients with NIHSS score greater than 15 will be recruited with perfusion abnormalities observed on Computed Tomography Perfusion (CTP) and the rest of the patients with no perfusion abnormalities but with clinically suspected AIS
- Pre-stroke mRS <4
- Aged 18- 85 years
- Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission)
Exclusion criteria 11
- Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
- Patients starting afamelanotide 24 hours or more from stroke.
- Intervention by endovascular thrombectomy (EVT)
- Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure
- Any evidence of hepatic or renal impairment
- Any other medical condition which may interfere with the study protocol
- Female who is pregnant or lactating
- Females of child-bearing potential not using highly effective contraceptive measures, for up to three months after the last injection
- Unable to undergo MRI brain evaluation
- Not suitable for trial participation according to judgment of the Principal Investigator (PI)
- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety of afamelanotide by monitoring and recording treatment-emergent AEs (TEAEs)
Secondary endpoints 4
- NIHSS scores compared to baseline
- Reperfusion volume of the ischaemic core and the penumbral ischaemic zone (salvageable tissue)
- mRS scores compared to baseline and pre-stroke; Activities of Daily Living (ADL) compared to baseline and pre-stroke
- MMSE scores compared to baseline
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9878459 · Product
- Active substance
- Afamelanotide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 0 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- D02BB02 — -
- MA holder
- CLINUVEL PHARMACEUTICALS LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Clinuvel Europe Limited
- Sponsor organisation
- Clinuvel Europe Limited
- Address
- Saint Kevins, 10 Earlsfort Terrace 10 Earlsfort Terrace
- City
- Dublin 2
- Postcode
- D02 T380
- Country
- Ireland
Scientific contact point
- Organisation
- Clinuvel Europe Limited
- Contact name
- Head of Clinical Operations
Public contact point
- Organisation
- Clinuvel Europe Limited
- Contact name
- Head of Clinical Operations
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-03-10 | 2023-03-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 20251118 CUV803 Summary of Results_EU SUM-106958
|
2025-11-18T16:27:50 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 20251118 CUV083_Laypersons Summary of results_EU | 2025-11-18T16:27:58 | Submitted | Laypersons Summary of Results |
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 20251118 CUV083_Laypersons Summary of results_EU | 1 |
| Protocol (for publication) | D1_Protocol_2022-500919-40-01_FP | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult ES_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal representative ES_FP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Afamelanotide_FP | 1 |
| Summary of results (for publication) | 20251118 CUV803 Summary of Results_EU | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-500919-40-01_FP | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Spain | Acceptable 2024-10-15
|
2024-10-15 |