In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’s mechanism of action and B-cell biology in the disease. This study (NCT02688985) will enroll up to 99 participants and is expected to end in September 2018.
Ocrevus is a humanized monoclonal antibody that selectively targets CD20-positive B-cells, decreasing the inflammatory processes that lead to the myelin and nerve cell damage observed in MS patients. Three distinct Phase 3 trials, OPERA I, OPERA II, and ORATORIO, have shown that Ocrevus has superior efficacy in patients with RMS, compared to Rebif, and that it can effectively reduce disease progression in patients with primary progressive MS (PPMS) patients.
Since it is the first investigational medicine that significantly reduces disability progression in both RMS and PPMS patients, it has been recently given priority review by the U.S. Food and Drug Administration (FDA) and the decision is expected by the end of the year.
Now, Genentech will be performing a randomized, open-label, multi-center, biomarker Phase 3 study to understand Ocrevus mechanism of action in relapsing multiple sclerosis. Participants will receive Ocrevus as two 300 mg intravenous infusions on days 1 and 15, followed by 600 mg infusions every 24 weeks, for a maximum of three doses. Patients will be randomized to undergo post-treatment lumbar puncture either at week 12, week 24, or week 52.
The study’s primary goals include measurement of changes from baseline in CD19 B-cells and CD3 T-cells in the cerebrospinal fluid (CSF) collected by lumbar puncture, as well as CSF changes in neurofilament light (NfL) chain, which is one of the main products of neuronal breakdown and function as a biomarker of neurodegeneration.
The study will be recruiting patients in the United States (California, Colorado, Connecticut, Massachusetts, Missouri, New York, North Carolina, Ohio, Oklahoma, and Texas), and Canada (British Columbia and Quebec). Anyone interested in participating can find more information, including contact information, by the study’s clinical trials.gov website.
Eligible patients include those diagnosed with RRMS, age 18 to 55 years, who are either treatment-naive or receiving disease-modifying therapies, including Rebif/Avonex (interferon-beta-1a), Betaseron/Betaferon (interferon-beta-1b), or Copaxone (glatiramer acetate).
In addition, participants must have had at least one of the following in the 12 months that preceded the time of enrollment: at least one relapse, at least one T1-weighted Gadolinum-enhancing lesion, or at least one new T2 lesion.
Read about Genentech’s other clinical trial for Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to DMTs, which is also recruiting patients in the U.S. and Canada.