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

PHASE3RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 21, 2020

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Ofatumumab

Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly subcutaneous injection that is in development for MS. Ofatumumab drug product (also referred as OMB157) is formulated as 20 mg/0.4 mL (50 mg/mL) solution for injection, provided in autoinjectors, for subcutaneous administration. The autoinjectors contain a small overfill to allow for a complete withdrawal of the labeled amount (20 mg) of ofatumumab.

DRUG

[F-18]PBR06

PET radiopharmaceutical. Subjects will undergo \[F-18\]PBR06-PET (microglial activation).

Trial Locations (1)

02115

RECRUITING

Partners MS Center, 60 Fenwood Road, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Brigham and Women's Hospital

OTHER