This trial is active, not recruiting.

Condition multiple sclerosis
Treatments rpc1063, beta interferon
Phase phase 3
Sponsor Celgene
Start date November 2014
End date December 2016
Trial size 1200 participants
Trial identifier NCT02294058, 2014‐002320‐27, RPC01-301


The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
0.5 mg RPC1063 oral capsule daily, matching weekly IM placebo
1 mg RPC1063 capsule daily, + weekly IM placebo injection
(Active Comparator)
Beta interferon IM injection weekly, + daily oral placebo
beta interferon

Primary Outcomes

Annualized relapse rate
time frame: 12 - 30 Months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria - EDSS score between 0 and 5.0 at baseline Exclusion Criteria: • Primary progressive multiple sclerosis

Additional Information

Official 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
Description The purpose of this study is to learn about the effects and safety of experimental medication RPC1063 taken by mouth in the treatment of Relapsing Multiple Sclerosis (RMS).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Celgene.