Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

NCT05084638 | Completed Phase 4 Results FDA Drug

• 1 other identifier: COMB157GUS10
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 36

Brief Summary

This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.

Conditions

Relapse Remitting Multiple Sclerosis

Keywords

early relapsing multiple sclerosis; ofatumumab; healthy control; treatment naïve; young adult population; MS-related disability; biomarker; MRI

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3)

  A participant is considered as achieved NEDA-3 if they were: * relapse-free, defined as no confirmed relapses in month 6 to 18. * 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18. * MRI activity-free, defined as no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants.

  Month 6 to month 18

Secondary Outcomes (16)

• Number of Confirmed MS Relapses in Months 6 to 18

  Month 6 to month 18

• Participant Based Annualized Relapse Rate (ARR)

  Month 6 to month 18

• Group Based Annualized Relapse Rate (ARR)

  Month 6 to month 18

• Percentage of Participants That Were 3-month Disability Progression-free

  Month 6 to month 18

• Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical

  Month 6 to month 18

Study Arms (2)

Ofatumumab

EXPERIMENTAL

Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30.

Drug: Ofatumumab

Healthy Control

NO INTERVENTION

Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment.

Interventions

Ofatumumab DRUG

20mg subcutaneous injection

Also known as: OMB157

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study
• Age 18-35 years
• Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
• Able to provide blood sample (no CSF will be collected in HC)
• Diagnosis of RRMS per McDonald Criteria (2010/2017)
• Within 6 months of diagnosis of clinically definite MS (CDMS)
• EDSS 0-3.0 (Inclusive)
• Treatment-naïve to MS DMT
• Able to obtain MRI and attend study visits at sites
• Able to use wearable device
• Able to provide blood sample (and CSF for sub-group n=15)

You may not qualify if:

• Confounding medical condition as determined by the investigator
• Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
• Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
• Use of experimental or investigational drugs for MS
• Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
• Relapse between screening and Baseline visits
• Known sensitivity to gadolinium; patients with chronic, severe kidney disease
• Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
• CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
• Known active malignancies
• Pregnant or nursing (lactating) women
• Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
• Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
• Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
• Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (36)

MD First Research

Chandler, Arizona, 85226, United States

Location

Barrow Neurological Clinics at St Josephs Hospital and MC

Phoenix, Arizona, 85013, United States

Location

Arizona Neuroscience Research LLC

Phoenix, Arizona, 85032, United States

Location

Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Lundquist Inst BioMed at Harbor

Torrance, California, 90509-2910, United States

Location

Regina Berkovich MD PhD Inc

West Hollywood, California, 90048, United States

Location

UC Health Neuroscience Ctr

Aurora, Colorado, 80045, United States

Location

MedStar Health

Washington D.C., District of Columbia, 20007, United States

Location

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, 32714, United States

Location

First Choice Neurology

Boca Raton, Florida, 33486, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

Orlando Health Clinical Trials

Orlando, Florida, 32806, United States

Location

Emerald Coast Neurology

Pensacola, Florida, 32514, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

University Of South Florida

Tampa, Florida, 33612, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

Location

Renown Institute for Neurosciences

Reno, Nevada, 89521, United States

Location

Neuroscience Institute at Hackensack

Hackensack, New Jersey, 07601, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Velocity Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Neurology Diagnostics Inc

Dayton, Ohio, 45408, United States

Location

Multiple Sclerosis Center of Excellence of OMRF

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107-5098, United States

Location

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, 37922, United States

Location

Univ of Texas Southwest Med Center

Dallas, Texas, 75390-9034, United States

Location

UT Health Science Center

Houston, Texas, 77030, United States

Location

Lonestar Neurology of San Antonio

San Antonio, Texas, 78258, United States

Location

Evergreen Health Multiple Sclerosis Center

Kirkland, Washington, 98034, United States

Location

MultiCare Neuroscience Center of Washington

Tacoma, Washington, 98405, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Caribbean Center for Clinical Research, Inc

Guaynabo, 00968, Puerto Rico

Location

MeSH Terms

Interventions

ofatumumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: January 25, 2022
• Primary Completion: February 4, 2025
• Study Completion: February 11, 2026
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (35)