Effects of ozanimod on myelin dynamics and neurodegeneration in patients with relapsingremitting multiple sclerosis: correlation with disease activity, cognition, fatigue,depression and quality of life

Overview

Sponsor-declared trial summary

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: Therapy, Efficacy

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

1. For RRMS patients: Age between 18 and 55 years (in line with phase III RCTs);
2. For RRMS patients:A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;
3. 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);
4. For RRMS patients: EDSS score =5.0 (in line with phase III RCTs);
5. For RRMS patients: Planned vaccinations completed prior to enrollment;
6. For RRMS patients: Provide informed consent signed for participation in the trial;
7. 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.
8. For HC subjects: Age between 18 and 55 years;
9. For HC subjects: Provide informed consent signed for participation in the trial.

Exclusion criteria 14

1. For RRMS patients: Age <18 or >55 years;
2. For RRMS patients: Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;
3. For RRMS patients: Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
4. For RRMS patients: History of psychiatric or mood disorders, or of drug or alcohol abuse;
5. For RRMS patients: MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;
6. For RRMS patients: One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;
7. For RRMS patients: The participant has previously participated in any clinical trial of ozanimod;
8. For RRMS patients: The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;
9. 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]).
10. For HC subjects: Age <18 or >55 years;
11. For HC subjects: Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
12. For HC subjects: History of psychiatric or mood disorders, or of drug or alcohol abuse;
13. For HC subjects: MRI contraindications;
14. 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

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

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

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 15 files

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

Application history

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