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
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
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.
Eligibility Criteria:
To be eligible to participate in this trial, patients must meet all of the following criteria:
Completed one of the parent trials
Does not have a condition that would require withdrawal from one of the parent trials
Has no conditions requiring treatment with a prohibited concomitant medication
Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
At Baseline (Day 1)
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
Acceptable methods of birth control in this study are the following:
Exclusion Criteria:
Lódzkie, 90-324, Poland
Mazowieckie, 02-097, Poland
Warminsko-mazurskie, 10-443, Poland
Pamplona/ Navarra, 31008, Spain
Sevillla, 41009, Spain
Zaporizhia, 69065, Ukraine
East Sussex, BN2 5BE, United Kingdom