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History of Changes for Study: NCT02576717
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Latest version (submitted June 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2015 None (earliest Version on record)
2 December 2, 2015 Study Status and Contacts/Locations
3 February 2, 2016 Study Status and Contacts/Locations
4 March 3, 2016 Study Status and Contacts/Locations
5 April 4, 2016 Study Status, Contacts/Locations and Study Identification
6 May 6, 2016 Study Status and Contacts/Locations
7 June 2, 2016 Study Status and Contacts/Locations
8 July 11, 2016 Study Status and Contacts/Locations
9 July 29, 2016 Contacts/Locations and Study Status
10 October 13, 2016 Study Status and Contacts/Locations
11 December 20, 2016 Recruitment Status, Eligibility, Study Status, Contacts/Locations and Study Description
12 May 4, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Identification
13 June 15, 2017 Recruitment Status, Study Status and Contacts/Locations
14 July 21, 2017 Contacts/Locations and Study Status
15 January 2, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
16 January 9, 2019 Contacts/Locations and Study Status
17 February 11, 2019 Contacts/Locations and Study Status
18 May 31, 2019 Study Status, Contacts/Locations and Eligibility
19 October 16, 2019 Study Status
20 July 21, 2020 Outcome Measures, Study Status and Eligibility
21 April 29, 2022 Contacts/Locations, Study Status and Study Design
22 June 9, 2022 Study Status, References and Contacts/Locations
23 June 23, 2022 Contacts/Locations and Study Status
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Study NCT02576717
Submitted Date:  October 13, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: RPC01-3001
Brief Title: A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Official Title: A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Active, not recruiting
Study Start: October 2015
Primary Completion: June 2020 [Anticipated]
Study Completion:
First Submitted: September 28, 2015
First Submitted that
Met QC Criteria:
October 13, 2015
First Posted: October 15, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 13, 2015
Last Update Posted: October 15, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Celgene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Detailed 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.
Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords: MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 2350 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1 mg RPC1063 (Ozanimod) oral capsule
1 mg RPC1063 (Ozanimod) oral capsule daily
Drug: RPC1063
Other Names:
  • Ozanimod
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services