9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

Palo Alto (17 mi)

Overseen byTarun Singhal, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Brigham and Women's Hospital

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?We aim to assess the effect of Ofatumumab on microglial activation using \[F-18\]PBR06 PET in MS patients in relation to changes in serum markers, MRI abnormalities and clinical impairment longitudinally over 9 months. Specific Aims: Specific Aim 1: To determine the effect of Ofatumumab on microglial activation in MS over 9 months. Specific Aim 2: To determine the time course of effect of Ofatumumab on microglial activation and its relationship with peripheral B-cell depletion, serum neurofilament light (sNfL) chain and glial-fibrillary acid protein (GFAP) levels and other serum biomarkers Specific Aim 3: To determine the relationship of PET changes following Ofatumumab initiation with 3T MRI changes and clinical parameters.

Eligibility Criteria

Treatment Details

1Treatment groups

Experimental Treatment

Group I: Subjects diagnosed with relapsing forms of multiple sclerosisExperimental Treatment2 Interventions

We plan to enroll 10 subjects with relapsing MS. All enrolled subjects will receive Ofatumumab 20 mg every 4 weeks, subcutaneously for 9 months during the study. Loading doses will be administered initially at 1, 7 and 14 days. During the study period, all enrolled subjects will undergo five PET scans using \[F-18\] PBR06 at 0, 5, 28, 90 and 273 days after starting treatment with Ofatumumab.

Ofatumumab is already approved in European Union, United States, United States for the following indications:

🇪🇺 Approved in European Union as Kesimpta for: