1200 People With Relapsing MS Needed For RPC1063, Avonex Clinical Trials
Clinical investigators worldwide are beginning to recruit 1,200 patients with relapsing multiple sclerosis for a study assessing the effectiveness of two different doses of RPC1063 (Receptos, Inc.), an experimental oral therapy, and Avonex® (interferon beta-1a, Biogen Inc.) in order to reduce relapse rate in patients. This study, called the Sunbeam Study, is being funded by Receptos, Inc.
RPC1063 is a selective sphingosine 1-phosphate receptor modulator that acts like Gilenya® (fingolimod, Novartis International AG) and was designed to retain specific white blood cells in the lymph nodes of the body in order to keep them from entering the central nervous system. MRI lesions in 258 participants suffering from relapsing MS previously enrolled in a phase 2 trial were reduced by 86 percent in two RPC1063 study arms in comparison to placebo. Most frequent adverse events in the previous study were headache, respiratory infections and urinary tract infections. No notable lung, heart, eye problems or cancers were reported.
Participants in the study will be given active treatment with Avonex or the experimental therapy and will be randomly selected to be part of one of the three groups of 400 patients taking oral RPC1063 (5 mg), RPC1063 (1 mg) or Avonex.
The primary outcome being assessed by the study is relapse rate at month 12, and secondary outcomes include MRI scans, alterations in the MS Functional Composite (a measure of disease progression), time to sustained disease progression, brain tissue volume loss, visual function and quality of life.
Prospective participants should be relapsing MS patients between the ages of 18 and 55 and with an RRMS diagnosis. More details on inclusion/exclusion criteria are available here https://www.sunbeamstudy.com.
Roche recently announced encouraging results on its investigational medicineocrelizumab as a therapy for patients with relapsing multiple sclerosis, which includes either RRMS or SPMS with relapses. Ocrelizumab was evaluated in two pivotal studies (OPERA I and OPERA II), where it was compared to interferon (IFN) beta-1a (Rebif®), the standard-of-care therapy in patients with relapsing MS.
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Labels: Clinical Trials