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Sphingosine 1-phosphate receptor modulator

RPC1063 for Ulcerative Colitis

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial will test the long-term safety and effectiveness of a drug called RPC1063 in people with ulcerative colitis.

Who is the study for?

This trial is for people with moderate to severe ulcerative colitis who have already been part of earlier RPC1063 trials. They must meet the criteria from their previous participation to join this extension study.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called RPC1063 in patients with ulcerative colitis who've used it before in prior studies.See study design

What are the potential side effects?

While specific side effects are not listed, they may include those typically associated with medications for ulcerative colitis such as nausea, headache, increased risk of infection, and liver issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs)

Number of Participants with Adverse Events of Special Interest

Number of Participants with Serious Adverse Events (SAEs)

+2 more

Secondary outcome measures

Change from Baseline in 9-point Mayo score

Change from Baseline in complete Mayo score

Change from Baseline in partial Mayo score

+9 more

Side effects data

From 2020 Phase 3 trial • 1012 Patients • NCT02435992

Anaemia

Colitis ulcerative

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 (Induction Period): RPC1063 1mg

Cohort 1: Placebo

Cohort 2 (Induction Period): RPC1063 1mg

Intervention (Maintenance Period): RPC1063 1mg

Placebo (Maintenance Period): Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: RPC0163 (Ozanimod)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RPC1063

2015

Completed Phase 3

~3610

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,093 Total Patients Enrolled

2 Trials studying Ulcerative Colitis

1,211 Patients Enrolled for Ulcerative Colitis

AnnKatrin Petersen, M.D., MSc.Study DirectorCelgene Corporation

1 Previous Clinical Trials

1,012 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

1,012 Patients Enrolled for Ulcerative Colitis

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,368,652 Total Patients Enrolled

11 Trials studying Ulcerative Colitis

8,393 Patients Enrolled for Ulcerative Colitis

Media Library

RPC1063 (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT02531126 — Phase 3

Ulcerative Colitis Research Study Groups: RPC0163 (Ozanimod)

Ulcerative Colitis Clinical Trial 2023: RPC1063 Highlights & Side Effects. Trial Name: NCT02531126 — Phase 3

RPC1063 (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02531126 — Phase 3

Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT02531126 — Phase 3

Frequently Asked Questions

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

In how many different locations is this trial being conducted today?

"Currently, this study is recruiting 93 patients from locations such as Tyler, London, and Ottawa."

Answered by AI

What are the previous findings of research on RPC1063?

"RPC1063 was first studied in 2015 at Local Institution - 554. There have been 16 completed studies since then, with 11 more currently underway. The majority of these active trials are based out of Tyler, Texas."

Answered by AI

Is this research the pioneer in its field?

"Celgene first sponsored a RPC1063 study in 2015. 2350 patients participated in the initial trial, which ultimately led to Phase 3 drug approval for the medication. Presently, there are 11 active trials taking place in 287 unique cities and 52 countries around the world."

Answered by AI

What are the benefits of taking RPC1063?

"RPC1063 is a medication that's approved for the treatment of sclerosis. However, it can also help patients with multiple sclerosis, active secondary progressive multiple sclerosis (spms), and carcinoma in situ."

Answered by AI

Are there any patients currently enrolled in this clinical trial?

"This study is not currently looking for new participants. However, there are 424 other clinical trials related to ulcerative colitis that are actively recruiting patients and 11 trials for RPC1063 admitting new participants."

Answered by AI

This research is open to what type of volunteers?

"This study requires 878 ulcerative colitis patients, between 18-75 years old, that also meet specific additional inclusion criteria. More information can be found at www.BMSStudyConnect.com"

Answered by AI

If a person is not yet 55 years old, could they still qualify for this clinical trial?

"This trial is only open to applicants aged 18-75. There are 72 other trials available for those under the age of 18 and 369 for seniors above 65 years old."

Answered by AI

How many participants are taking part in this scientific experiment at most?

"This study is not actively searching for patients at this time. The clinical trial was first posted on 12/2/2015 and was last edited on 10/24/2022. If you are exploring for other studies, there are presently 424 studies actively admitting participants with ulcerative colitis and 11 studies for RPC1063 actively recruiting patients."

Answered by AI

When might RPC1063 be cleared for general use by the FDA?

"RPC1063 has undergone Phase 3 clinical trials, meaning that there is some data supporting its efficacy and multiple rounds of data supporting safety. Consequently, our team at Power rates RPC1063's safety as a 3."

Answered by AI