Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

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

Tracking Information

• First Submitted Date: May 26, 2016
• First Posted Date: June 13, 2016
• Last Update Posted Date: March 27, 2018
• Actual Study Start Date: June 23, 2016
• Actual Primary Completion Date: October 20, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Multiple Sclerosis

Intervention

Drug: RPC1063

Oral capsule daily

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2018): 22
• Original Estimated Enrollment (submitted: June 7, 2016): 24
• Actual Study Completion Date: October 20, 2017
• Actual Primary Completion Date: October 20, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02797015
• Other Study ID Numbers: RPC01-1001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Celgene
• Study Sponsor: Celgene
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Celgene
• Verification Date: March 2018