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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576717
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2495 participants
Allocation: N/A
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 : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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


Outcome Measures
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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


Eligibility Criteria
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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:

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)

  5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  6. 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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: James Sheffield, MD, MBA, MS Celgene
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02576717    
Other Study ID Numbers: RPC01-3001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Keywords provided by Celgene:
MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases