Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis

NCT04925557 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 00003884
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Secondary-progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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;

  12 months

Secondary Outcomes (2)

• Change From Baseline in PET Activation at 6,12,24 and 36 Months Between Mayzent and Active Comparator

  6, 12, 24 and 36 months

• Number of New Ultrasmall Superparamagnetic Iron Oxide Particles

  6, 12, 24 and 36 months

Other Outcomes (11)

• MRI Measures Between Mayzent and Control-treated Groups (PBVC)

  12, 24 and 36 months

• MRI Measures Between Mayzent and Control-treated Groups (PCVC)

  12, 24 and 36 months

• MRI Measures Between Mayzent and Control-treated Groups(PTVC)

  12, 24 and 36 months

Study Arms (2)

Ocrevus

ACTIVE COMPARATOR

Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Ocrevus by their neurologist.

Drug: Ocrevus

Mayzent

ACTIVE COMPARATOR

Patients diagnosed with secondary-progressive multiple sclerosis who have been prescribed Mayzent by their neurologist.

Drug: Mayzent

Interventions

Mayzent DRUG

PET imaging to evaluate the effects of Mayzent on the microglia of the brain.

Mayzent

Ocrevus DRUG

PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.

Ocrevus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Age between 18 and 60 years
• Have EDSS scores between 3.0 and 6.5
• Treatment naïve to both Mayzent and to Ocrevus
• Not being on S1P modulators or B-cell therapies for the last 9 months
• Subjects starting treatment as part of their clinical routine
• Be willing and able to comply with the study procedures for the duration of the trial
• Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) authorization before any study-related activities are carried out
• Normal kidney functioning (creatinine clearance \>59)
• No known hypersensitivity reactions to contrast agents
• Have received treatment within 30 days prior to enrollment with steroids or any other concomitant immunomodulatory therapies
• Have received an investigational drug or experimental procedure within the past 30 days
• Low affinity (LAB) for the DNA single nucleotide polymorphism (SNP) of the TSPO gene on chromosome 22q13.2, using a TaqMan assay
• A CYP2C9\*3/\*3 genotype
• Have experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure in the last 6 months
• Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo, Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

siponimod; ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Robert Zivadinov
• Organization: State University of New York at Buffalo

rzivadinov@bnac.net

716-248-2140

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysts had no knowledge of study drug assignment. .
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 14, 2021
• Study Start: November 13, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 5, 2023
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)