Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
Multiple sclerosis patients in relapse and remission form
The primary objective of this study is to evaluate the effects of ozanimod in RRMS patients in limiting the progression of brain neurodegenerative phenomena over the course of 2 years.
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 22 Jun 2022 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513960-24-00
- EudraCT number
- 2021-003577-63
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The primary objective of this study is to evaluate the effects of ozanimod in RRMS patients in limiting the progression of brain neurodegenerative phenomena over the course of 2 years.
Conditions and MedDRA coding
Multiple sclerosis patients in relapse and remission form
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- For RRMS patients: Age between 18 and 55 years (in line with phase III RCTs);
- For RRMS patients:A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;
- For RRMS patients: RRMS patients starting treatment with ozanimod, according to European Medicines Agency (EMA) and Italian Medicine Agency (AIFA) criteria (if available at the moment of study initiation);
- For RRMS patients: EDSS score =5.0 (in line with phase III RCTs);
- For RRMS patients: Planned vaccinations completed prior to enrollment;
- For RRMS patients: Provide informed consent signed for participation in the trial;
- For RRMS patients: Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.* * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet.
- For HC subjects: Age between 18 and 55 years;
- For HC subjects: Provide informed consent signed for participation in the trial.
Exclusion criteria 14
- For RRMS patients: Age <18 or >55 years;
- For RRMS patients: Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;
- For RRMS patients: Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
- For RRMS patients: History of psychiatric or mood disorders, or of drug or alcohol abuse;
- For RRMS patients: MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;
- For RRMS patients: One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;
- For RRMS patients: The participant has previously participated in any clinical trial of ozanimod;
- For RRMS patients: The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;
- For RRMS patients: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG]).
- For HC subjects: Age <18 or >55 years;
- For HC subjects: Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
- For HC subjects: History of psychiatric or mood disorders, or of drug or alcohol abuse;
- For HC subjects: MRI contraindications;
- For HC subject: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoints of this study are to assess, in RRMS patients treated with ozanimod, the changes from baseline over 2 years of: • Global brain atrophy (i.e., percent brain volume change [PBVC]); • Regional GM volume; • Regional WM volume; • Thalamic volume; • Cortical volume.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
-
L04AA · Product
- Pharmaceutical form
- PHF00230MIG
- Route of administration
- ORAL USE
- Max daily dose
- 920 µg microgram(s)
- Max total dose
- 667460 µg microgram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AA — SELECTIVE IMMUNOSUPPRESSANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Massimo Filippi
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Massimo Filippi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 30 | 1 |
| 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 |
|---|---|---|---|---|---|
| Italy | 2022-06-22 | 2022-09-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Italy | Acceptable 2024-06-24
|
2024-07-01 |