Receptors Inc: Efficacy and Safety of Oral RPC1063 in RMS Patients

• Research type

  Research Study

• Full title

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

• IRAS ID

  146621

• Contact name

  Basil Sharrack

• Contact email

  basil.sharrack@sth.nhs.uk

• Sponsor organisation

  Receptos, Inc.

• Eudract number

  2012-002714-40

• Clinicaltrials.gov Identifier

  NCT01628393

• Research summary

  This study is investigating an experimental drug called RPC1063 for the treatment of Multiple Sclerosis (MS). The study is split into two parts; part A of the study is placebo controlled. This will be followed by part B which has an active control, interferon (IFN) β-1a (Avonex®). The UK will only participate in part B. The purpose of Part B is to investigate whether this new drug is safer and more effective in the treatment of MS, compared with an approved standard treatment, the active control Avonex®.
  RPC1063 is an oral capsule medication that acts on the immune system by making certain types of white blood cells (lymphocytes including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation.
  Approximately 1200 patients between the ages of 18 and 55 from North America and Europe who meet the eligibility requirements will take part in this study. Patients will be randomly assigned 1:1:1 to receive one of two doses of investigational drug RPC1063 (0.5 mg or 1 mg) to be taken daily by mouth, or the standard treatment interferon (IFN)β-1a (Avonex®) 30μg which will be taken via a intramuscular injection weekly. The patients and study doctors will not know which treatment has been assigned. In order to maintain this blind each patient will also be given a placebo capsule or placebo injection (dummy treatment that contains no active ingredient) to take depending on which group they are assigned to. Patients will be expected to participate and take their treatment for 24 months during which they will be asked to visit their study site about 11 times for various follow-ups. The study is being sponsored by Receptos, Inc.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  14/EM/0129

• Date of REC Opinion

  29 May 2014

• REC opinion

  Further Information Favourable Opinion