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A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02576717
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2015
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: RPC1063 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 16, 2015
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 mg RPC1063 (Ozanimod) oral capsule
1 mg RPC1063 (Ozanimod) oral capsule daily
Drug: RPC1063
Other Name: Ozanimod




Primary Outcome Measures :
  1. Safety and tolerability of RPC1063 in patients with RMS as assessed by evaluation of adverse events [ Time Frame: Up to 5 years ]
    Safety as assessed by evaluation of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • Completed one of the parent trials: RPC01-201, RPC01-301 or RPC01-1001
  • Does not have a condition that would require withdrawal from one of the parent trials (RPC01-201, RPC01-301, RPC01-1001)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576717


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Sponsors and Collaborators
Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02576717     History of Changes
Other Study ID Numbers: RPC01-3001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Keywords provided by Celgene:
MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases