Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society.
The trial is an open-label study, meaning that all participants will receive Ocrevus. The treatment will be given in two 300 mg infusions, 14 days apart, followed by a single 600 mg infusion every 24 weeks. A maximum of four doses over 96 weeks will be given.
About 600 patients ages 18 to 55, who have been sick for 10 years or less, will be eligible for the study if they have undergone up to two previous treatment rounds with other therapies, each lasting for at least six months. The most recent treatment course had to have been stopped for a lack of treatment effects.
Pregnant or breastfeeding women, people in need of chronic treatment with corticosteroids or immunosuppressants, and patients who have certain infections, including hepatitis B or C, HIV, syphilis, or tuberculosis, will not be eligible for participation.
The study, which will be run at 80 study centers across the U.S., will mainly focus on measuring the percent of participants who do not experience a relapse, new disease activity on magnetic resonance imaging (MRI) brain scans, or disability progression over a 96-week period.
Researchers will also analyze how many patients experience disease activity in the form of relapse, new brain lesions, or disability progression after 24 and 48 weeks, and measure the time period before patients experience any of these events.
For more information or to enroll in the trial, patients or their physicians can contact the study’s staff by calling 1-888-662-6728, or by emailing [email protected]. Patients and doctors will asked to use the trial reference ID number: MN30035. A full list of study sites is available below.
Ocrevus is an antibody treatment that blocks a molecule called CD20 on the surface of immune B-cells. Researchers believe that these cells are involved in mediating MS disease processes and nerve damage.
The drug has been explored in several earlier Phase 3 trials in patients with both relapsing and progressive types of MS, where it has shown positive results.
The OPERA clinical trial (NCT01412333) in relapsing MS showed that Ocrevus treatment allowed more patients to reach “No Evidence of Disease Activity (NEDA)” than those treated with Rebif (interferon beta-1a). NEDA is defined as no relapses, no confirmed disability progression, and no new brain lesions detected on brain scans.
The ORATORIO trial (NCT01194570) focused on patients with primary progressive MS, and treatment resulted in nearly half of the treated patients reaching No Evidence of Progression over 120 weeks of treatment.
Based on these data, Genentech is hoping to get Ocrevus approved for both relapsing and progressive forms of MS. The U.S. Food and Drug Administration (FDA) is currently reviewing the marketing application. The company recently announced that the FDA had extended the date for a decision. The new date is March 28, 2017. The extension was caused by the submission of additional material by Roche, which owns Genentech, and is not related to the safety or effectiveness of the treatment.
Considering the data gathered by Genentech to date, it is expected that the treatment will be approved. If it indeed is, a scenario that many U.S. neurologists find likely, Ocrevus will be the first treatment for progressive MS on the market.
La Jolla, California
San Francisco, California
Fort Collins, Colorado
Kansas City, Kansas
New Orleans, Louisiana
St. Louis, Missouri
Freehold, New Jersey
Newark, New Jersey
Teaneck, New Jersey
Buffalo, New York
Latham, New York
Mineola, New York
New York, New York
Patchogue, New York
Stony Brook, New York
Raleigh, North Carolina
Oklahoma City, Oklahoma
Round Rock, Texas
San Antonio, Texas
Salt Lake City, Utah