for people ages 18-55 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Bruce Cree
Headshot of Bruce Cree
Bruce Cree



The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

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


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.


Multiple Sclerosis, MS, RMS, Relapsing Multiple Sclerosis, Sclerosis, Ozanimod, RPC1063


For people ages 18-55

Eligibility Criteria:

To be eligible to participate in this trial, patients must meet all of the following criteria:

  1. Completed one of the parent trials
  2. Does not have a condition that would require withdrawal from one of the parent trials
  3. Has no conditions requiring treatment with a prohibited concomitant medication
  4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:

At Baseline (Day 1)

  • CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
  • Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
  • 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:

  • Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
  • Placement of an intrauterine device (IUD)
  • Placement of an intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner
  • Sexual abstinence.

Exclusion Criteria:


  • Multiple Sclerosis Center at UCSF
    San Francisco California 94158 United States
  • Local Institution - 120
    San Francisco California 94158 United States
  • Local Institution - 103
    Fresno California 93710 United States
  • Neuro Pain Medical Center
    Fresno California 93710 United States
  • Alta Bates Summit Medical Center
    Berkeley California 94705 United States
  • Local Institution - 110
    Berkeley California 94705 United States

Lead Scientist at UCSF

  • Bruce Cree
    Bruce Cree, MD, PhD, MAS is a Professor of Clinical Neurology and is the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. Dr. Cree completed his MD and PhD in Biochemistry at UCSF. His neurology residency training was at Columbia University.


in progress, not accepting new patients
Start Date
Completion Date
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
Phase 3 Multiple Sclerosis Research Study
Study Type
About 2350 people participating
Last Updated