Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment rpc1063
Phase phase 3
Sponsor Celgene
Start date October 2015
End date June 2020
Trial size 2350 participants
Trial identifier NCT02576717, RPC01-3001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1 mg RPC1063 (Ozanimod) oral capsule daily
rpc1063 Ozanimod

Primary Outcomes

Measure
Safety and tolerability of RPC1063 in patients with RMS as assessed by evaluation of adverse events
time frame: Up to 5 years

Eligibility Criteria

Male or female participants of any age.

Eligibility Criteria: - Completed one of the parent trials: RPC01-201 or RPC01-301 - Does not have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301) - Has no conditions requiring treatment with a prohibited medication - Ability to provide written informed consent and to be compliant with the schedule of protocol assessments - Patients of reproduction potential (males and females) must practice an acceptable method of birth control

Additional Information

Official title A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Description The trial is an open label extension study. Eligible patients from the RPC01-201 and RPC01-301 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Celgene.