Phase 3 Efficacy and Safety study of Oral RPC1063 in RMS Patients

• Research type

  Research Study

• Full title

  A Phase 3, Multi-center, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

• IRAS ID

  167238

• Contact name

  Basil Sharrack

• Contact email

  basil.sharrack@sth.nhs.uk

• Sponsor organisation

  Celgene International II Sàrl (CIS II)

• Eudract number

  2014-002320-27

• Clinicaltrials.gov Identifier

  NCT02294058

• Duration of Study in the UK

  2 years, 7 months, 28 days

• Research summary

  This study is investigating an experimental drug called RPC1063 for the treatment of relapsing multiple sclerosis (RMS). Two doses of RPC1063 will be examined which will be administered daily for at least 12 months. The purpose of this study is to investigate whether this new drug is safer and more effective in the treatment of RMS, compared with an approved standard treatment, the active control interferon (IFN) β-1a (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, Latin America, New Zealand 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 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 (inactive substance that contains no medication) to take depending on which group they are assigned to. Patients will be expected to participate and take their treatment for at least 12 months during which they will be asked to visit their study site a minimum of 8 times (additional visits may be required) for various study related procedures. The study is being sponsored by Receptos, Inc.
  

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0302

• Date of REC Opinion

  22 Jul 2015

• REC opinion

  Further Information Favourable Opinion