MS Trial Alert: Investigators Recruiting 1200 People with Relapsing MS For Study of Oral RPC1063
Summary: Investigators worldwide are recruiting 1200 people with relapsing MS for a study testing the effectiveness of two different doses of the experimental oral therapy RPC1063 (Receptos, Inc.) versus Avonex® (interferon beta-1a, Biogen Inc.) at reducing the rate of relapses. The study, called the Sunbeam Study, is funded by Receptos, Inc.
Rationale: RPC1063 is a selective sphingosine 1-phosphate receptor modulator (similar to the mode of action of Gilenya® [fingolimod, Novartis International AG]). It is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. In a phase 2 trial in 258 participants with relapsing MS, cumulative new, active MRI lesions were reduced by 86% in two RPC1063 arms over placebo. Most common adverse events were respiratory infections, headache, and urinary tract infection. No notable heart, lung, eye problems or cancers were noted. (Reported at the ACTRIMS-ECTRIMS meeting in 2014 - Abstract LB1.1.)
Eligibility and Details: Participants should be aged 18 through 55, with a diagnosis of relapsing MS. Further details on inclusion and exclusion criteria are available from the contact below.
All participants will receive active treatment with either the experimental therapy or Avonex. Participants will be randomly assigned to one of three groups of 400 participants each, and will take either oral RPC1063 (.5 mg) and an inactive placebo injected into muscle once weekly; RPC1063 (1 mg) and inactive placebo injected into muscle once weekly; or Avonex and an oral placebo daily. Participants will continue to receive treatment until the last person enrolled has been treated for at least 12 months or discontinued.
The primary outcome being measured by this study is relapse rate at 12 months. Secondary outcomes include MRI scans, time to sustained disease progression, changes in the MS Functional Composite (a measure of disease progression), visual function, brain tissue volume loss, and quality of life.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study web site at https://www.sunbeamstudy.com or call Jeff Hartung, Receptos at (858) 652-5736.
Sites are going to be recruiting in the following cities:
Long Beach, California
San Francisco, California
Ormond Beach, Florida
Golden Valley, Minnesota
Las Vegas, Nevada
Lebanon, New Hampshire
Brooklyn, New York
Johnson City, New York
New York, New York
Raleigh, North Carolina
Morgantown, West Virginia
Avonex is a registered trademark of Biogen Idec.
Gilenya is a registered trademark of Novartis AG.