Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis (relapsing-remitting, relapsing-progressive); MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2023-000018-16-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-25
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

¿ Age 18-65 years
¿ Relapsing MS (relapsing-remitting, relapsing-progressive) diagnosed according to 2017 revision
of McDonald criteria
¿ Treatment with ozanimod started within 30-90 days before the enrollment
¿ Met 1 of the following disease activity criteria:
1) at least one relapse within 12 months beforethe therapy initiation or
2) as at least one relapse within 24 months and at least one gadolinium-enhancing lesion
within 12 months before the therapy initiation
¿ EDSS score between 0 and 5 at the time of ozanimod initiation
¿ At least 2mL of CSF and 10 mL of blood acquired before the beginning of ozanimod treatment and stored at -80°C
¿ Availability of an MRI scan performed at least 90 days before the beginning of ozanimod including 3DT1,3D FLAIR/T2-weighted sequences and 3D Gradient Echo Planar Imaging
Susceptibility weighted (Magnitude and Phase)
¿ Positive varicella zoster virus immunoglobulin G antibody status or varicella zoster virus vaccination at least 28 days before ozanimod initiation
¿ Pregnancy test negative and on effective contraceptive drugs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

¿ Individuals with inactive primary or secondary progressive multiple sclerosis;
¿ Disease duration more than 15 years with an EDSS of 2.0 or less;
¿ History of relapse or systemic corticosteroid use from 30 days before therapy initiation
¿ Hypersensitivity to ozanimod or to any of the listed excipients
¿ Primary o secondary immunodeficiency syndrome or lymphocyte count not within normal limits due to any cause, ongoing immunosuppressive therapy (including chronic use of
steroid)
¿ Resting heart rate less than 55 beats per min (bpm) at screening; patients who in the last 6 months experienced myocardial infarction (MI), unstable angina, stroke, transient ischaemic
attack (TIA), decompensated heart failure requiring hospitalisation or New York Heart Association (NYHA) Class III/IV heart failure, patients with history or presence of second-degree
atrioventricular (AV) block Type II or third- degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker
¿ Primary or secondary immunodeficiency syndrome, lymphocyte count not within normal limits due to any cause
¿ Ongoing immunosuppressive therapy (including chronic use of steroid)
¿ Platelet count < 100.000/mcL; Hemoglobin < 8.5 g/dL; Leukocytes < 3500/mcL; Neutrophils <1500/mcL
¿ Active acute infections or chronic infections (including HBV, HCV, HIV, TBC)
¿ Active malignancies or history of malignancies
¿ Severe hepatic impairment (Child-Pugh class C)
¿ Pregnancy or breastfeeding.
¿ Fertile women who do not use effective methods of contraception.
¿ Received a live vaccine within 4 weeks prior to ozanimod administration or intends to receive a live vaccination during the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified