Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
192
Countries
1
Sites
10
Stroke
To demonstrate the efficacy of Diroximel Fumarate (DRF) as compared with placebo in reducing Peri-Haematoma Oedema (PHO) at day 8 in patients with spontaneous intracerebral haemorrhage (ICH).
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Lille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 19 May 2026 → ongoing
- Decision date (initial)
- 2026-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ANR - RHU TIPITCH · PHRC-N 2023
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To demonstrate the efficacy of Diroximel Fumarate (DRF) as compared with placebo in reducing Peri-Haematoma Oedema (PHO) at day 8 in patients with spontaneous intracerebral haemorrhage (ICH).
Secondary objectives 2
- To evaluate the efficacy of DRF as compared with placebo in improving the functional outcome of ICH patients at 6 months (end of follow-up).
- To evaluate the safety of DRF in ICH patients.
Conditions and MedDRA coding
Stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10022753 | Intracerebral haemorrhage | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients 18 years or older (no upper age limit)
- Patients admitted for a first-ever or recurrent symptomatic supratentorial spontaneous ICH confirmed by brain imaging
- Administration of study treatment no later than 48 hours after symptom onset or since last seen without neurological deficit
- Written consent obtained
- Patient with social insurance in France
- Patient willing to comply with all study procedures and duration
Exclusion criteria 16
- Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated > 60ml)
- Severe coma (Glasgow Coma Scale <6)
- Pure intraventricular hemorrhage
- ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct
- Patient planned for surgical evacuation of ICH (Evacuation, Decompressive hemicraniectomy, External ventricular drain)
- Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)
- Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY; patients taking dimethyl fumarate)
- Severe lymphopenia at admission (lymphocyte counts < 0.5 x 109/L)
- Medical history of progressive multifocal leukoencephalopathy
- Patients unable to swallow
- Severe pre-ICH dependency (modified Rankin score of 5)
- Life expectancy < 1 year related to comorbidities
- Late-stage organ (acute cardiac, renal or hepatic failure)
- Decision already taken for palliative (end of life) care with withdrawal of active treatment
- Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
- Adults who are deprived of their liberty by judicial or administrative decision
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.
Secondary endpoints 2
- Functional outcome: global disability assessed by overall distribution of mRS score at 6 months (end of follow-up) (shift analysis)
- Safety outcome: The rate of severe adverse events (see chapter 10 “Safety Assessment”) occurring between the date of randomization and the end of follow-up (six-month visit).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Vumerity 231 mg gastro-resistant hard capsules
PRD10194646 · Product
- Active substance
- Diroximel Fumarate
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 924 mg milligram(s)
- Max total dose
- 924 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX09 — -
- Marketing authorisation
- EU/1/21/1585/001
- MA holder
- BIOGEN NETHERLANDS B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Lille
- Sponsor organisation
- Centre Hospitalier Universitaire De Lille
- Address
- 2 Avenue Oscar Lambret, Cs 70001 Cs 70001
- City
- Lille Cedex
- Postcode
- 59037
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- Dr Lauren PUY
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- Mme Brigitte COURTOIS
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 192 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Urgences Cérébro-Vasculaires, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Service de Neurologie, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire Rouen
NEUROLOGIE VASCULAIRE - UNITE DE SOINS INTENSIFS NEUROVASCULAIRES, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Dijon
Service hospitalo-universitaire de neurologie, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Centre Hospitalier Universitaire De Toulouse
Service de neurologie vasculaire, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Centre Hospitalier Universitaire De Bordeaux
Service de Neurologie et Unité Neuro-Vasculaire (UNV), Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Regional Universitaire De Tours
Neurologie vasculaire, 2 Boulevard Tonnelle, 37000, Tours
Hospices Civils De Lyon
Service de neurologie vasculaire, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Lille
Service de neurologie et pathologie neurovasculaire, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
CHRU De Nancy
Service de Neurologie, Unité Neurovasculaire, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
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 |
|---|---|---|---|---|---|
| France | 2026-05-19 | 2026-05-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522687-33_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_2025-522687-33 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF patient poursuite_2025-522687-33_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ICF patient_2025-522687-33_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ICF proche_2025-522687-33_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L2_Carnet de suivi patient_FR_2025-522687-33_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Lettre au medecin traitant_FR_2025-522687-33 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-FR_Vumerity | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis_ENG_2025-522687-33_Redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_Synopsis_FR_2025-522687-33_Redacted | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-30 | France | Acceptable 2026-02-04
|
2026-02-26 |