Multiple SclerosisPhase 4OMNIAOMSNCT05777902
Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
A Phase 4 study testing Ozanimod Oral Capsule in people with Multiple Sclerosis, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ozanimod Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2023to 11 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidimensional Integrated Assessment of Neurological and Immunological Patterns to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
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.
Read the detailed description
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.
The primary objective of the study is to use this multidimensional integrated approach to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.
The endpoint that relate to this objective is 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 after Ozanimod treatment.
Patients must meet all the following inclusion criteria to be eligible for enrolment into the study:
- Diagnosis of MS accordingly to 2017 revised McDonald criteria;
- Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.);
- Age between 18 and 45 years;
- EDSS score from 0 to 4;
- Signature and date of written ICF prior to entering the study;
- Conditions
- Multiple Sclerosis
- Being tested
- Ozanimod Oral Capsule
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozanimod Oral CapsuleDrug
Also called Zeposia
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).
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: Drug: Ozanimod Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start31 Jan 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777902
- Sponsor's protocol ID
- EUDRACT 2021-005860-24
- Acronym
- OMNIAOMS
- Status last verified
- Feb 2023
- First submitted
- 9 Mar 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Integrated Assessment of Neurological and Immunological Patterns to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT05777902
- Acronym / sponsor ID
- OMNIAOMS / EUDRACT 2021-005860-24
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The primary objective of the study is to use this multidimensional integrated approach to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.
The endpoint that relate to this objective is 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 after Ozanimod treatment.
Patients must meet all the following inclusion criteria to be eligible for enrolment into the study:
- Diagnosis of MS accordingly to 2017 revised McDonald criteria;
- Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.);
- Age between 18 and 45 years;
- EDSS score from 0 to 4;
- Signature and date of written ICF prior to entering the study;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Drug: Ozanimod Oral Capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) 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;
Key exclusion criteria (8 listed)
- The presence of any of the following will exclude a patient from study enrolment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozanimod Oral CapsuleAlso: ZeposiaWe 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). | Drug | Patient |
Primary outcome
verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.
Time frame: 12 months
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.
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozanimod Oral Capsule in people with Multiple Sclerosis, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.