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Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

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ClinicalTrials.gov Identifier: NCT02797015
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE June 23, 2016
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • Maximum plasma concentration (Cmax) [ Time Frame: 24 hours after the last RPC1063 dose on Day 85 ]
    Maximum plasma concentration (Cmax)
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Approximately 3 months ]
    Area under the plasma concentration-time curve (AUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • Adverse Events [ Time Frame: Up to 28 days after the last RPC1063 dose ]
    Number of participants with treatment-emergent adverse events
  • EDSS (Expanded Disability Status Scale) [ Time Frame: Up to the last RPC1036 dose on Day 85 ]
    Changes from baseline in EDSS
  • Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count [ Time Frame: Up to 28 days after the last RPC1063 dose ]
    Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
Official Title  ICMJE A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
Brief Summary The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
Detailed Description The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: RPC1063
Oral capsule daily
Study Arms  ICMJE
  • Experimental: 1 mg RPC1063
    1 mg RPC1063 oral capsule daily
    Intervention: Drug: RPC1063
  • Experimental: 0.5 mg RPC1063
    0.5 mg RPC1063 oral capsule daily
    Intervention: Drug: RPC1063
Publications * Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5). pii: e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
24
Actual Study Completion Date  ICMJE October 20, 2017
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • MS, as diagnosed by the revised 2010 McDonald criteria
  • Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
  • Expanded disability status scale (EDSS) score between 0 and 6.0

Key Exclusion Criteria:

  • Primary progressive MS
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02797015
Other Study ID Numbers  ICMJE RPC01-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celgene
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP