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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 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
3%
Anaemia
1%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
642 Previous Clinical Trials
129,695 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
1,519 Previous Clinical Trials
3,371,311 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
~64 spots leftby Feb 2025
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