RPC1063 for Relapsing and Active Multiple Sclerosis : RADIANCE

RPC1063 (an S1P Modulator) for Relapsing and Active Multiple Sclerosis (RADIANCE, RPC01-201-B)

A Phase 2/3, Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients (RADIANCE, RPC01-201 Part B)

Description:
RPC1063 is a once-a-day, oral, anti-inflammatory medication that works as an “S1P receptor modulator”. RPC1063 is thought to be effective in MS by reducing the number of inflammatory cells within the blood stream, thereby reducing the number of inflammatory cells that get into the brain. Another example of an S1P receptor modulator is fingolimod, which was approved for relapsing MS in 2010.

The rationale of this study is to determine the efficacy and safety of RPC1063 in relapsing forms of MS. Over two years, the study medicine will be compared to interferon beta-1a weekly (Avonex®). Participants will randomized to take either RPC1063 or the interferon.

The study will include 24 months of treatment, with a 30 day screening period before treatment, and a 4 week follow-up visit.

People eligible for participation include:

  1. Age 18 – 55.
  2. Diagnosis of Relapsing Multiple Sclerosis.
  3. At least 1 relapse within the last12months, or at least 1 relapse within the last24 monthswith 1 contrast-enhancing MRI lesion.
  4. Baseline EDSS 0 – 5.0 (No disability through ambulates 200 meters independently).
  5. For female participants, no desire for pregnancy during the study, and for men and women, use of reliable contraception for 30 days after the last dose of study treatment.
  6. No reasons not to take beta-interferon 1a (e.g. intolerable side effects, allergy)
  7. Those with diabetes type 2 need to be under good glycemic control with no complications.
  8. No history of active infections. No cardiac, liver, kidney, or lung disease. No suicidality.

Length of Trial:
The trial will be 26 months, including 4 weeks for screening, 24 months of treatment, and follow-up 4 weeks later. There are 12 clinic visits, including 1 at screening, 10 over the 24 months of treatment, and 1 at 4 week follow-up.