Retinal OCT biomarkers for ublituximab response in relapsing MS

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

We will test whether special retinal OCT scans can find signs of immune activity in people with relapsing MS who are starting ublituximab or already on a stable MS medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Drugs / interventions: Ublituximab, rituximab, ocrelizumab, ofatumumab
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06864936 on ClinicalTrials.gov

What this trial studies

This interventional study will use specialized optical coherence tomography (OCT) scans at enrollment and two follow-up timepoints to look for retinal imaging biomarkers of immune cell activity in people with relapsing MS. One group will start ublituximab (Briumvi) following their physician's referral while a comparison group will remain on a stable disease-modifying therapy. The study plans to enroll about 30 participants and compare imaging changes between the groups over time. Participants with ocular disease that prevents clear OCT imaging or recent B-cell depleting therapy are excluded.

Who should consider this trial

Good fit: Adults 18–65 with relapsing MS who are either newly referred to start ublituximab or currently on a stable disease-modifying therapy and able to undergo OCT imaging are ideal candidates.

Not a fit: People with eye conditions that interfere with OCT, recent treatment with B-cell depleting drugs, or those unable to attend in-person visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the imaging biomarkers could give doctors a noninvasive way to monitor immune activity and help guide B-cell therapy decisions in MS.

How similar studies have performed: Structural OCT measures have been used in MS research, but applying OCT to detect immune-cell activity during B-cell therapy is a relatively new approach with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

For Ublituximab Group:

1. Ages 18-65
2. A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria.
3. A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician.

For Comparison Group:

1. Ages 18 - 65
2. A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria.
3. Currently on a stable dose of disease modifying treatment for MS with no plans for alternative therapy for the following year.

Exclusion Criteria:

For Ublituximab Group:

1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma.
2. Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months.
3. History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy
4. Any chronic or active infection that would preclude anti-CD20 therapy. This may include but is not limited to active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests, tuberculosis, and human immunodeficiency virus (HIV).
5. Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration

For Comparison Group:

1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma.
2. Treatment with any B-cell depleting disease modifying therapy (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months, or plans to initiate such a therapy in the following year.

Where this trial is running

Baltimore, Maryland

• University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Daniel Harrison, MD — University of Maryland, Baltimore
• Study coordinator: Kerry Naunton, RN

Conditions Multiple Sclerosis - Relapsing-remitting