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Sphingosine 1-phosphate receptor modulator

RPC1063 for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has no conditions requiring treatment with a prohibited concomitant medication
At Baseline (Day 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall: from first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
Awards & highlights

Study Summary

This trial is testing a new drug to treat relapsing multiple sclerosis. The goal is to see if it is safe and effective.

Eligible Conditions
  • Multiple Sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You do not have a condition that would require withdrawal from one of the parent trials.
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You are taking monoamine oxidase inhibitors (eg, selegiline, phenelzine).
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You must agree to use a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit.
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You are able to provide written informed consent and to be compliant with the schedule of protocol assessments.
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You are using a hormonal contraceptive that inhibits ovulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall: from first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall: from first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
+15 more
Secondary outcome measures
Annualized Relapse Rate (ARR)
Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
+12 more

Side effects data

From 2020 Phase 3 trial • 1012 Patients • NCT02435992
3%
Anaemia
1%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Maintenance Period): Placebo
Cohort 1 (Induction Period): RPC1063 1mg
Intervention (Maintenance Period): RPC1063 1mg
Cohort 1: Placebo
Cohort 2 (Induction Period): RPC1063 1mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1 mg RPC1063 (Ozanimod) oral capsuleExperimental Treatment1 Intervention
1 mg RPC1063 (Ozanimod) oral capsule daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPC1063
2015
Completed Phase 3
~3610

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
125,426 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
4,469 Patients Enrolled for Multiple Sclerosis
James Sheffield, MD, MBA, MSStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,499 Previous Clinical Trials
3,365,048 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
15,248 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

RPC1063 is often given to patients for what reason?

"RPC1063 is the standard medication for treating sclerosis, but it can also help patients with multiple sclerosis, active secondary progressive multiple sclerosis, and carcinoma in situ."

Answered by AI

Have other medical studies like this one been conducted in the past?

"RPC1063 has 11 ongoing clinical trials in 287 cities and 52 countries. The first trial was sponsored by Celgene and completed in 2015 after enrolling 2350 participants. Phase 3 of the trial resulted in drug approval. Since 2015, there have been a total of 16 RPC1063 trials."

Answered by AI

Does RPC1063 have a long and successful clinical trial history?

"RPC1063 was first studied in 2015 at Local Institution - 554. There have been a total of 16 completed trials since the initial study. There are 11 studies ongoing, with a significant number taking place in Raleigh, North carolina."

Answered by AI

Could you walk me through the dangers associated with RPC1063?

"RPC1063 has undergone multiple rounds of testing and has been found to be safe. It is estimated to be a 3 on a scale of 1 to 3."

Answered by AI

What hope does this trial offer to patients?

"The primary outcome of this study is to evaluate Adverse events of special interest (AESIs) over a period of up to approximately 7 years. Secondary outcomes include The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit, Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale (EDSS) of 1.0 points or more from baseline, and Annualized relapse rate."

Answered by AI

Does this research allow for patients that are elderly?

"The target patient population for this study are individuals that are over 18 but under 55 years old."

Answered by AI

Does this research project have several testing facilities within the state?

"So far, 46 research sites have been recruited for this study, such as Raleigh Neurology Associates PA in Raleigh, Bhupesh Dihenia MD PA in Lubbock, and Axiom Clinical Research of Florida in Tampa."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Alta Bates Summit Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~265 spots leftby Mar 2025