Summary

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

Description

Summary

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

Details

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.

Keywords

Multiple Sclerosis MS RMS Relapsing Multiple Sclerosis Sclerosis RPC1063

Eligibility

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)

  1. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  2. 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 (oestrogen 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

Male patients:

Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study for at least 75 days after treatment discontinuation.

All patients:

Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.

Locations

  • Multiple Sclerosis Center at UCSF
    San Francisco California 94158 United States
  • Neuro Pain Medical Center
    Fresno California 93710 United States

Lead Scientist

  • 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.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02576717
Phase
Phase 3
Study Type
Interventional
Last Updated