Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Ability to provide written informed consent and be compliant with the study protocol

• The treating neurologist's independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient

• Diagnosis of RR-MS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment

• Treatment-naïve (i.e. no prior disease modifying therapy)

• Disease duration from the onset of MS symptoms: less than 15 years in patients with an EDSS greater than 5.0 at screening

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Joseph Sabatino, MD, PhD
joseph.sabatinojr@ucsf.edu
(415) 353-2069
Time Frame
Start Date: 2025-02-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 5
Treatments
Experimental: RR-MS
Two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov