Upcoming Ocrelizumab Trial Targets Changes in Cerebrospinal Fluid of MS Patients
Phase 3 study seeks to further understand the mechanisms of ocrelizumab.
An upcoming clinical trial will examine changes in cerebrospinal fluid to further understand how ocrelizumab (Ocrevus) works to harness multiple sclerosis (MS), according to Multiple Sclerosis News Today.
The open-label, phase 3 trial aims to recruit 104 patients with both relapsing and primary progressive MS across 19 locations in North America, Germany, and Sweden.
Participants will receive two 300-mg infusions of ocrelizumab 2 weeks apart, followed by additional 600-mg infusions given at weeks 24 and 48, according to the report.
In the trial, investigators will analyze levels of Neurofilament Light (NFL) and CD19+ B cells and CD3+ T cells in the spinal fluid of patients administered ocrelizumab.
“NFL is a marker of axonal injury,” Hideki Garren, group medical director of Ocrevus at Genentech, told Multiple Sclerosis News Today. “And the aim of the study is to assess the potential impact of Ocrevus on this process, as well as on the inflammation.”
The primary outcome of the study is changes in the fluid levels of these biomarkers. Secondary outcomes include the presence of anti-drug antibodies and the concentration of ocrelizumab in the patients’ blood and spinal fluid, according to Multiple Sclerosis News Today. Patients will be followed for up to 3.5 years to record any adverse events.
“This is a hypothesis-generating study to elucidate the effect of Ocrevus on biomarkers of inflammation and neurodegeneration in the CSF [cerebrospinal fluid] and peripheral blood of patients with relapsing MS and primary progressive MS, in correlation with clinical and MRI outcome measures,” Garren told Multiple Sclerosis News Today.
For the study, participants will receive 2 spinal taps—–in addition to other testing––and will be divided into 5 groups.
Three groups comprised of patients with relapsing MS will receive the same treatment but will undergo spinal taps at different times. All will be sampled before treatment begins and against at either week 12, 24, or 52, according to MS News Today.
The fourth group of patients with relapsing MS will have a 12-week treatment delay before receiving ocrelizumab. The investigators will collect spinal fluid at the start of the delay period and again right before they are administered their first dose of ocrelizumab.
In the fifth group, patients with primary progressive MS will be given a spinal tap prior to the first dose and again at 52 weeks, after the last ocrelizumab infusion.
The investigators hope that analyzing factors in the cerebrospinal fluid will provide a clearer picture of activity going on in the brain, MS News Today reported.
Genentech expects the study to be completed by September 2018.