Back to resultsPharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RPC1063
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Sclerosis focused on measuring MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis
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
Sites / Locations
- Breastlink Medical Group, Inc.
- Multiple Sclerosis Center at UCSF
- Raleigh Neurology Associates PA
- Neurology and Neuroscience Associates Inc.
- Hope Neurology MS Center
- Central Texas Neurology Consultants PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 mg RPC1063
0.5 mg RPC1063
Arm Description
1 mg RPC1063 oral capsule daily
0.5 mg RPC1063 oral capsule daily
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Secondary Outcome Measures
Adverse Events
Number of participants with treatment-emergent adverse events
EDSS (Expanded Disability Status Scale)
Changes from baseline in EDSS
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02797015
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2016 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 mg RPC1063
Arm Type
Experimental
Arm Description
1 mg RPC1063 oral capsule daily
Arm Title
0.5 mg RPC1063
Arm Type
Experimental
Arm Description
0.5 mg RPC1063 oral capsule daily
Intervention Type
Drug
Intervention Name(s)
RPC1063
Intervention Description
Oral capsule daily
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Maximum plasma concentration (Cmax)
Time Frame
24 hours after the last RPC1063 dose on Day 85
Title
Area under the plasma concentration-time curve (AUC)
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
Approximately 3 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with treatment-emergent adverse events
Time Frame
Up to 28 days after the last RPC1063 dose
Title
EDSS (Expanded Disability Status Scale)
Description
Changes from baseline in EDSS
Time Frame
Up to the last RPC1036 dose on Day 85
Title
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Description
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %)
Time Frame
Up to 28 days after the last RPC1063 dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Breastlink Medical Group, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Multiple Sclerosis Center at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Raleigh Neurology Associates PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology and Neuroscience Associates Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Hope Neurology MS Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Central Texas Neurology Consultants PA
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32737072
Citation
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):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.
Results Reference
derived
Learn more about this trial
Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
We'll reach out to this number within 24 hrs