Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.

NCT05777902 | Terminated Phase 4

• 1 other identifier: EUDRACT 2021-005860-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration. Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.

  To evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and afterOzanimod treatment.

  12 months

Study Arms (1)

Patient

EXPERIMENTAL

Drug: Ozanimod Oral Capsule

Interventions

Ozanimod Oral Capsule DRUG

We propose to integrate measurements obtained using multiple tools. Patients will undergo MRI and hdEEG procedures, and blood samples will be obtained for the immunological and biochemical studies on the same day. The study of the immune system's status will include an extensive immunophenotypic analysis, a functional characterization following ex vivo stimulation of innate immune cells, and the measurement of soluble products in the serum, such as cytokines. Cellular traits of interest include the absolute numbers and relative proportions of specific cell subsets, transcriptional states, secretory functions, proliferative capacity or cytolytic potential. Specifically, the following antibody combination will constitute the core of the immunophenotypic analysis: HLADR CD11c, CD38, CD14, CD123, lineage (CD3, CD56, CD19).

Also known as: Zeposia

Patient

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering the study;

You may not qualify if:

• The presence of any of the following will exclude a patient from study enrolment:
• Ongoing immunomodulatory or immunosuppressive treatment;
• Other autoimmune comorbidities (i.e. antiphospolipid syndrome);
• Treatment with steroids in the last 30 days before enrollment;
• Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days;
• Patients unable to read and understand the documents of the study.
• Participation in any interventional clinical trials or compassionate use programs
• Contraindications and "not-recommendations" reported in SmP

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

IRCCS Fondazione Santa Lucia

Roma, RM, 00179, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 21, 2023
• Study Start: January 31, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: January 15, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)