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Monoclonal Antibodies

[F-18]PBR06 for Multiple Sclerosis

Phase 3
Recruiting
Led By Tarun Singhal, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 9 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of Ofatumumab on microglial activity
Secondary study objectives
Relationship between changes in Microglial activity and CD19 counts
Relationship between changes in Microglial activity and MRI-based brain atrophy changes
Relationship between changes in Microglial activity and cognitive disability
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved
[F-18]PBR06
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,597 Total Patients Enrolled
31 Trials studying Multiple Sclerosis
14,694 Patients Enrolled for Multiple Sclerosis
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,225 Total Patients Enrolled
14 Trials studying Multiple Sclerosis
6,756 Patients Enrolled for Multiple Sclerosis
Tarun Singhal, MDPrincipal InvestigatorBrigham and Women's Hospital
5 Previous Clinical Trials
176 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
157 Patients Enrolled for Multiple Sclerosis
~2 spots leftby Nov 2025
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