1200 People With Relapsing MS Needed For RPC1063, Avonex Clinical Trials

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by Isaura Santos |

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Clinical investigatorsĀ worldwide are beginning to recruitĀ 1,200 patientsĀ with relapsing multiple sclerosisĀ for a study assessingĀ the effectiveness of two different doses of RPC1063 (Receptos, Inc.), an experimental oral therapy, and AvonexĀ® (interferon beta-1a, Biogen Inc.) in order toĀ 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 GilenyaĀ® (fingolimod, Novartis International AG) and was designed to retain specificĀ white blood cells in the lymph nodes of the body in order toĀ keep them from entering the central nervous system. MRI lesions in 258 participants suffering fromĀ relapsing MS previously enrolled in a phase 2 trial were reduced by 86 percent in two RPC1063 study arms in comparison toĀ placebo. Most frequentĀ 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 givenĀ active treatment with Avonex or theĀ 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 assessedĀ by theĀ studyĀ is relapse rate at month 12, and secondary outcomes include MRI scans, alterationsĀ 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 participantsĀ should be relapsing MS patients between the ages of 18 andĀ 55 and with an RRMS diagnosis. MoreĀ details on inclusion/exclusion criteria are availableĀ hereĀ https://www.sunbeamstudy.com.

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