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Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis: one year phase 4 experimental study
EU CTIS ID: 2024-518859-27-00
What this study is testing
The aim of the project is to clarify the effect of ozanimod on compartmentalized inflammation by studying its effect on meningeal inflammation in CSF
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-65 years
- Relapsing-remitting MS (RRMS) diagnosed according to 2017 revision of McDonald criteria
- Treatment with ozanimod started within 30-90 days before the enrollment according to the AIFA indications for prescribing ozanimod (dose escalation regimen of ozanimod from Day 1 to Day 7: Days 1 – 4 0.23 mg once daily; Days 5 – 7 0.46 mg once daily; Days 8 and thereafter 0.92 mg once daily)
- Met 1 of the following disease activity criteria: 1) at least one relapse within 12 months before the therapy initiation or 2) at least one gadolinium-enhancing lesion or at least new T2/FLAIR lesion within 12 months before the therapy initiation
- Available EDSS score between 0 and 5 at the time of ozanimod initiation
- At least 2mL of CSF and 10 mL of blood acquired any time before the beginning of ozanimod treatment and stored at -80°C
You likely can't join if
- Individuals with inactive primary or secondary progressive multiple sclerosis
- Active acute infections or chronic infections including HBV, HCV, HIV, ● Active or chronic TBC assessed performing an intradermal reaction test or chest x-ray ● 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
- Macular oedema excluded by an ophthalmologic evaluation for patients with diabetes mellitus, uveitis or positive history of retinopathy, before starting treatment with ozanimod
See the full eligibility criteria
Who can join
- Age 18-65 years
- Relapsing-remitting MS (RRMS) diagnosed according to 2017 revision of McDonald criteria
- Treatment with ozanimod started within 30-90 days before the enrollment according to the AIFA indications for prescribing ozanimod (dose escalation regimen of ozanimod from Day 1 to Day 7: Days 1 – 4 0.23 mg once daily; Days 5 – 7 0.46 mg once daily; Days 8 and thereafter 0.92 mg once daily)
- Met 1 of the following disease activity criteria: 1) at least one relapse within 12 months before the therapy initiation or 2) at least one gadolinium-enhancing lesion or at least new T2/FLAIR lesion within 12 months before the therapy initiation
- Available EDSS score between 0 and 5 at the time of ozanimod initiation
- At least 2mL of CSF and 10 mL of blood acquired any time 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 a highly effective methods of contraception
What rules you out
- Individuals with inactive primary or secondary progressive multiple sclerosis
- Active acute infections or chronic infections including HBV, HCV, HIV, ● Active or chronic TBC assessed performing an intradermal reaction test or chest x-ray ● 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
- Macular oedema excluded by an ophthalmologic evaluation for patients with diabetes mellitus, uveitis or positive history of retinopathy, before starting treatment with ozanimod
- 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 or 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 hospitalization 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.