Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis

NCT06495593 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: ML45461
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Ocrelizumab; Lymph node; Lymphocyte

Outcome Measures

Primary Outcomes (1)

• Lymphocyte analysis

  Percent reduction in B cells and T cell subsets in lymphoid tissue of MS patients following ocrelizumab treatment.

  3 months

Study Arms (1)

RR-MS

EXPERIMENTAL

Two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

Standard ocrelizumab dosing

RR-MS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• MS Related:
• Diagnosis of secondary progressive MS without relapses for at least 1 year.
• Diagnosis of primary progressive MS.
• Prior treatment with any disease modifying therapy for MS.
• Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency).
• Infection Related:
• Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis).
• History of recurrent aspiration pneumonia requiring antibiotic therapy.
• History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy).
• Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit.
• Cancer Related:
• \- History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix or the uterus that have been excised and resolved with documented clean margins on pathology).
• Women's health-related:
• Pregnant or lactating, or intending to become pregnant during the study
• Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study drug.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph Sabatino, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)