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.
The purpose of this research study is to determine if the experimental drug, RPC1063, is safe and effective in the treatment of relapsing multiple sclerosis (MS), compared to an FDA approved standard treatment of IFN β-1a (Avonex®) 30 μg.
UCSF will participate in Part B of the study only.
Two different doses of RPC1063 will be tested against Avonex®. Patients will be assigned to receive one of the following three study drugs and the corresponding placebo:
- 0.5mg RPC1063 (oral capsule) – and placebo injection
- 1 mg RPC1063 (oral capsule) – and placebo injection
- IFN β-1a (Avonex® - 30 μg injection) and placebo capsulesc
Patients will have a 67% (2 out of 3) chance of being assigned to one of the active doses of RPC1063 and 33% (1 out of 3) chance of being assigned to Avonex®.
In addition, because this study is double blinded, you will also be “treated” with a placebo. A placebo is one that contains no active substance but may resemble a real medication. Since Avonex® is administered by injection, and RPC1063 is administered orally (capsule), patients enrolled in this study will be required to receive both types of delivery (orally and injection) so that no one will be able to tell which active medication the patient is truly being given. This study is completely blinded, meaning, you, your doctor, and the Sponsor, Receptos, Inc. will not know if you‟re getting RPC1063 or Avonex® until the entire study is concluded for all subjects.
Participation in this study will last for approximately 28 months and include a 2 year treatment period.
If you have been diagnosed with a relapsing form of MS, are between the ages of 18-55, have not been treated with natalizumab, fingolimod or other SIP1R agonists and are able to come to UCSF for study visits you may be eligible to participate.
For more information, please contact Nancy Shum
with ‘Radiance inquiry
’ in the subject line, or by calling (415) 502 7219