A Phase 2/3 interventional study of Mayzent and Ocrevus in Secondary-progressive Multiple Sclerosis, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by State University of New York at Buffalo · Phase 2/3, Interventional, and Diagnostic
To assess the efficacy of Mayzent on microglia pathology in patients with active SPMS, as compared to the active control group of MS patients treated with the Ocrevus, as measured by changes in microglial activation in the lesional and non-lesional NAWM and NAGM and in the peri-plaque area of chronic lesions in the brain.
Multiple sclerosis (MS) is primarily a demyelinating disease of the central nervous system (CNS), but many patients also undergo progressive atrophy, especially in the gray matter (GM). GM atrophy plays a particularly prominent role in development of cognitive and physical disability in MS. Evidence is mounting that there is a profound infiltration of activated microglia and blood-borne macrophages throughout the lesions, whereas in slowly expanding (smoldering) or chronic active expanding lesions, the microglia and macrophages are concentrated as a dense rim around the lesions. Microglia is also activated, in a more diffuse way, in the white matter (WM) and GM with concomitant axonal degeneration and meningeal inflammation. Thus, chronic activation of microglia has been linked to neurodegeneration in the progressive phase of the disease and development of brain atrophy.
No longitudinal studies in MS examined the association between development of microglia-related pathology in patients treated with siponimod (Mayzent®). This will be the first study to examine the treatment effect of Mayzent on microglia in MS.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 8 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist.
Drug: Ocrevus
Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist.
Drug: Mayzent
PET imaging to evaluate the effects of Mayzent on the microglia of the brain.
PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.
Change From Baseline in PET Activation at 12 Months
Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients under treatment with Mayzent when 100% of patients reach 12 months;
Time frame: 12 months
Change From Baseline in PET Activation at 6,12,24 and 36 Months Between Mayzent and Active Comparator
Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients treated with Mayzent and active control group at 6, 12, 24 and 36 months from baseline
Time frame: 6, 12, 24 and 36 months
Number of New Ultrasmall Superparamagnetic Iron Oxide Particles
The cumulative number of new ultrasmall superparamagnetic iron oxide (USPIO) particles contrast enhancing (CE) active lesions on T1-weighted images between Mayzent and active control group, as measured at 6, 12, 24 and 36 months from baseline.
Time frame: 6, 12, 24 and 36 months
MRI Measures Between Mayzent and Control-treated Groups (PBVC)
Percent brain volume change (PBVC) between baseline and 12, 24, and 36 months
Time frame: 12, 24 and 36 months
MRI Measures Between Mayzent and Control-treated Groups (PCVC)
Percent cortical volume change (PCVC), between baseline and 12, 24, and 36 months
Time frame: 12, 24 and 36 months
MRI Measures Between Mayzent and Control-treated Groups(PTVC)
Percent thalamus volume change (PTVC) between baseline and 12, 24, and 36 months
Time frame: 12, 24 and 36 months
MRI Measures Between Mayzent and Control-treated Groups (QSM)
Quantitative susceptibility mapp (QSM) change between baseline and 12, 24, and 36 months
Time frame: 12, 24 and 36 months
Cumulative Number of New Gadolinium CE Lesions
The cumulative number of new gadolinium CE lesions on T1-weighted images at months 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Cumulative Number of New or Newly Enlarging T2 Lesions
The cumulative number of new or newly enlarging hyperintense T2 lesions measured at months 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Absolute Change in Hyperintense T2 Lesions Volume
The absolute change in hyperintense T2-lesion volume (LV) measured at months 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Absolute Change in Hypo-intense T1 Lesions Volume
The absolute change in hypo-intense T1-lesion volume (LV) measured at months 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Absolute Change in Serum Neurofilament and Glial Protein
The absolute change in serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (GFAP) at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months
Association Between Imaging and Clinical and Cognitive Outcomes
The association between imaging and clinical and cognitive outcomes, incl. the composite EDSS+SDMT, over 24 and 36 months of the study
Time frame: 24 and 36 months
Number of Participants With Treatment Related Adverse Events
Safety of Mayzent and active control group over 12, 24, and 36 months of the study
Time frame: 12, 24, and 36 months
Patients diagnosed with active SPMS according to the Lublin 2014 criteria. Activity is determined by MRI activity (contrast-enhancing lesions; new and unequivocally enlarging T2 lesions) and/or clinical relapses in the 24 months prior to the study baseline. Patients were recruited from 2 medical clinics.
| Milestone | Ocrevus | Mayzent |
|---|---|---|
| Started | 5 | 3 |
| Completed | 0 | 0 |
| Not completed | 5 | 3 |
| Withdrew: Study closed | 5 | 3 |
Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients under treatment with Mayzent when 100% of patients reach 12 months;
No measurements were reported for this outcome.
Change from baseline in PET activation of PBR06 in lesional and non-lesional NAWM and NAGM in the brain of the patients treated with Mayzent and active control group at 6, 12, 24 and 36 months from baseline
No measurements were reported for this outcome.
The cumulative number of new ultrasmall superparamagnetic iron oxide (USPIO) particles contrast enhancing (CE) active lesions on T1-weighted images between Mayzent and active control group, as measured at 6, 12, 24 and 36 months from baseline.
No measurements were reported for this outcome.
Percent brain volume change (PBVC) between baseline and 12, 24, and 36 months
No measurements were reported for this outcome.
Percent cortical volume change (PCVC), between baseline and 12, 24, and 36 months
No measurements were reported for this outcome.
Percent thalamus volume change (PTVC) between baseline and 12, 24, and 36 months
No measurements were reported for this outcome.
Quantitative susceptibility mapp (QSM) change between baseline and 12, 24, and 36 months
No measurements were reported for this outcome.
The cumulative number of new gadolinium CE lesions on T1-weighted images at months 6, 12, 24 and 36 months
No measurements were reported for this outcome.
The cumulative number of new or newly enlarging hyperintense T2 lesions measured at months 6, 12, 24 and 36 months
No measurements were reported for this outcome.
The absolute change in hyperintense T2-lesion volume (LV) measured at months 6, 12, 24 and 36 months
No measurements were reported for this outcome.
The absolute change in hypo-intense T1-lesion volume (LV) measured at months 6, 12, 24 and 36 months
No measurements were reported for this outcome.
The absolute change in serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (GFAP) at 6, 12, 24 and 36 months
No measurements were reported for this outcome.
The association between imaging and clinical and cognitive outcomes, incl. the composite EDSS+SDMT, over 24 and 36 months of the study
No measurements were reported for this outcome.
Safety of Mayzent and active control group over 12, 24, and 36 months of the study
No measurements were reported for this outcome.
Collected over Baseline to 5 months.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocrevus | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Mayzent | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Ocrevus | Mayzent |
|---|---|---|
| Allergic ReactionInjury, poisoning and procedural complications | 0/5 | 2/3 |
Patients with relapsing remitting Multiple Sclerosis.
| Age, Continuous(years) | Ocrevus | Mayzent | Total |
|---|---|---|---|
| Mean | 51 (39 to 63) | 53 (49 to 55) | 52 (44 to 59) |
| Sex: Female, Male(Participants) | Ocrevus | Mayzent | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 3 | 2 | 5 |
| Race and Ethnicity Not Collected(Participants) | Ocrevus | Mayzent | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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State University of New York at Buffalo