RPC-1063 for Multiple Sclerosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple SclerosisRPC-1063 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effects of ozanimod on cognitive processing speed in 250 subjects with relapsing multiple sclerosis over the course of 36 months. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). There is no planned protocol extension following the end of the study.

Eligible Conditions
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Up to approximately 3 years

Year 3
Adverse Events (AEs)
Annualized relapse rate (ARR)
Change from baseline in Symbol Digit Modalities Test (SMDT)
Expanded Disability Status Scale (EDSS)
Fatigue Severity Scale (FSS)
GdE lesion volume over 3 years
Hospital Anxiety and Depression Scale (HADS)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Nine-hole Peg Test (9-HPT)
Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3
Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3
Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes
Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years
Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline
Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)
Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)
Proportion of subjects with an increase in raw score of ≥ 3 points from baseline
Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
Timed 25-foot Walk (T25W)
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ozanimod 0.5 mg
13%Nasopharyngitis
13%Headache
8%Upper Respiratory Tract Infection
7%Alanine Aminotransferase Increased
6%Influenza Like Illness
6%Orthostatic Hypotension
5%Urinary Tract Infection
5%Pharyngitis
5%Hypertension
4%Gamma-Glutamyltransferase Increased
3%Pyrexia
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02047734) in the Ozanimod 0.5 mg ARM group. Side effects include: Nasopharyngitis with 13%, Headache with 13%, Upper Respiratory Tract Infection with 8%, Alanine Aminotransferase Increased with 7%, Influenza Like Illness with 6%.

Trial Design

1 Treatment Group

Administration of RPC-1063
1 of 1

Experimental Treatment

250 Total Participants · 1 Treatment Group

Primary Treatment: RPC-1063 · No Placebo Group · Phase 3

Administration of RPC-1063
Drug
Experimental Group · 1 Intervention: RPC-1063 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
173,108 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
6,566 Patients Enrolled for Multiple Sclerosis
Michael Connor, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,406 Previous Clinical Trials
3,308,469 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
14,086 Patients Enrolled for Multiple Sclerosis

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female 18 to 65 years of age (inclusive) at the time of signing of the ICF.
You have a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
You have a diagnosis of RMS in the past 5 years.
You have a history of RMS DMT use.

Who else is applying?

What state do they live in?
New York66.7%
North Carolina33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Weill Cornell Medical College100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%