A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
• Intervention / Treatment: Drug: Ublituximab

Detailed Description

This study is being done to see how safe and effective ublituximab is when given to older adult patients for their RMS. Since RMS patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in RMS patients between the ages of 55-80 years.

Primary endpoints include:

• Incidence of infection rate from Baseline to Month 24/EOS (including UTI and other active acute, opportunistic and/or chronic infection)
• Incidence of TEAS/SAEs from Baseline to Month 24 with consideration to nature, severity, and occurrence rate of AEs

Approximately 20 participants are expected to be enrolled. Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Salvatore Napoli, MD; Phone Number: 781-551-5812; Email: ksciore@myneurodr.com
• Study Contact Backup: Name: Rachel ODonnell, BS; Phone Number: 2 781-551-5812; Email: ResearchNCNE@myneurodr.com

Study Locations

• United States
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Recruiting
      • Neurology Center of New England P.C.
      • Principal Investigator: Salvatore Napoli, MD
      • Contact: Rachel ODonnell; Phone Number: x2 781-551-5812; Email: ResearchNCNE@myneurodr.com
      • Contact: Jillian Pellegrini; Phone Number: x2 781-551-5812; Email: ResearchNCNE@myneurodr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database

Description

Inclusion Criteria:

• Signed informed consent
• Aged 55-80 years old
• Diagnosis of RMS according to the 2017 Revised McDonald criteria
• Anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label

Exclusion Criteria:

• Active participation in an interventional clinical trial for MS
• Received initial dose of ublituximab more than 6 months prior to study entry
• History of life-threatening infusion reaction on any anti-CD20 therapy
• Evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)	Incidence of infection rate from Baseline to Month 24/End of Study	From Baseline to Month 24/End of Study
Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)	Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study	From Baseline to Month 24/End of Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of new and/or enlarging T2 lesions on all available brain MRI scans	Change from Baseline to Month 24/End of Study in total number of new and/or enlarging T2 lesions on all available brain MRI scans	From Baseline to Month 24/End of Study
Functional Assessment (Expanded Disability Status Scale (EDSS))	Change from Baseline to Month 24/End of Study in EDSS	From Baseline to Month 24/End of Study
Multiple Sclerosis Impact Scale (MSIS-29)	Change from Baseline to Month 24/End of Study in Multiple Sclerosis Impact Scale (MSIS-29)	From Baseline to Month 24/End of Study
Absolute lymphocyte count (ALC)	Change from Baseline to Month 24/End of Study in ALC	From Baseline to Month 24/End of Study
Immunoglobulin levels	Change from Baseline to Month 24/End of Study in immunoglobulin levels	From Baseline to Month 24/End of Study
Functional Assessment (Timed 25-Foot Walk Test (T25-FW))	Change from Baseline to Month 24/End of Study in T25-FW	From Baseline to Month 24/End of Study

Collaborators and Investigators

• Sponsor: Neurology Center of New England P.C.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Pro00078205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes