Trial Outcomes & Findings for 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis (NCT NCT04510220)

Last Updated: 2026-01-27

Results Overview

The primary endpoint of the study will be the regional glial activity on PET (GALP) measurements at 3 months and 9 months compared to baseline. Individualized z-score maps of brain parenchymal microglial activation were generated using a voxel-by-voxel comparison between each subject's 60-90 minute PET standardized uptake value ratio (SUVR) images (globally normalized) and a control dataset of 9 healthy individuals. GALP scores were calculated as the sum of voxel-by-voxel z-scores \>4 in a given region divided by the total number of voxels in that region. A z-score of 0 represents the reference population mean. Higher z-scores indicate worse outcomes. A z-score \>4 is considered positive and contributes to the average GALP score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 3 Months, and 9 Months

Results posted on

2026-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis 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 day 0, 5, 28, 90 (Month 3) and 273 (Month 9) after starting treatment with Ofatumumab.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis n=9 Participants 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.
Age, Continuous	40.2 years n=41 Participants
Sex: Female, Male Female	7 Participants n=41 Participants
Sex: Female, Male Male	2 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Race (NIH/OMB) White	7 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants
Region of Enrollment United States	9 participants n=41 Participants

PRIMARY outcome

Timeframe: Baseline, 3 Months, and 9 Months

Population: Due to the unavailability of the PET tracer, PET scans at all time points were completed by the first 5 participants only. The baseline, 3 month, and 9 month results for these 5 participants are presented here.

Outcome measures

Outcome measures
Measure	Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis n=5 Participants 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: 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. \[F-18\]PBR06: PET radiopharmaceutical. Subjects will undergo \[F-18\]PBR06-PET (microglial activation).
Glial Activity Load on PET Baseline	0.968 Z-score Standard Deviation 0.063
Glial Activity Load on PET 3 Months	0.799 Z-score Standard Deviation 0.103
Glial Activity Load on PET 9 Months	0.759 Z-score Standard Deviation 0.171

SECONDARY outcome

Timeframe: Baseline, 5 Days, and 9 Months

Population: Due to the unavailability of the PET tracer, PET scans at all time points were completed by the first 5 participants only. The baseline, 5 day, and 9 month results for these 5 participants are presented here.

Peripheral % CD19 (B Cells) counts at 5 days and 9 months compared to baseline. This is the proportion of B cells (which express CD19) relative to all lymphocytes.

Outcome measures

Outcome measures
Measure	Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis n=5 Participants 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: 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. \[F-18\]PBR06: PET radiopharmaceutical. Subjects will undergo \[F-18\]PBR06-PET (microglial activation).
% CD19 Counts Baseline	14.70 Percentage Standard Deviation 9.75
% CD19 Counts 5 Days	0.98 Percentage Standard Deviation 1.10
% CD19 Counts 9 Months	0.04 Percentage Standard Deviation 0.09

Adverse Events

Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects Diagnosed With Relapsing Forms of Multiple Sclerosis n=10 participants at risk 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 (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. PET radiopharmaceutical. Subjects will undergo \[F-18\]PBR06-PET (microglial activation).
General disorders Scanning related issues	30.0% 3/10 • From enrollment until the end of follow-up, up to 9 months.
Product Issues Injection related issues	80.0% 8/10 • From enrollment until the end of follow-up, up to 9 months.
General disorders IV related issues	30.0% 3/10 • From enrollment until the end of follow-up, up to 9 months.

Additional Information

Dr. Tarun Singhal

Brigham and Women's Hospital

Phone: 617-264-3043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place