← Back to Search

Sphingosine 1-phosphate receptor modulator

Oral Ozanimod for Pediatric Ulcerative Colitis

Phase 2 & 3

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit

Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial will test whether the drug ozanimod is effective and safe in treating ulcerative colitis in children who haven't responded to other treatments.

Who is the study for?

This trial is for children with moderate to severe active ulcerative colitis who haven't responded well to conventional treatments like oral aminosalicylates, corticosteroids, immunomodulators, or biologics. They must have UC beyond the rectum confirmed by endoscopy. Kids with positive tests for C. difficile, recent apheresis, immune deficiencies, genetic disorders causing colitis, or diagnosed with Crohn's disease can't participate.Check my eligibility

What is being tested?

The study is testing the effectiveness and safety of an oral medication called Ozanimod in pediatric patients. It aims to see if this drug can help achieve and maintain clinical remission in kids who have not had success with standard therapies for their ulcerative colitis.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with medications like Ozanimod may include headache, high blood pressure, liver enzyme elevations which could indicate liver injury; respiratory infections; and potential increase in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with moderate to severe Ulcerative Colitis before the screening.

Select...

My UC didn't improve with treatments like steroids or biologics.

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.

Secondary outcome measures

Absolute change from baseline in Absolute Lymphocyte Count (ALC)

Incidence of AEs leading to discontinuation from treatment

Incidence of AEs of special interest (AESIs)

+10 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734

49%

Influenza Like Illness

12%

Headache

11%

Nasopharyngitis

Upper Respiratory Tract Infection

Orthostatic Hypotension

Pyrexia

Alanine Aminotransferase Increased

Urinary Tract Infection

Hypertension

Pharyngitis

Gamma-Glutamyltransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Interferon Beta-1a

Ozanimod 0.5 mg

Ozanimod 1 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ozanimod Low DoseExperimental Treatment1 Intervention

Group II: Ozanimod High DoseExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozanimod

2020

Completed Phase 3

~3510

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,639 Previous Clinical Trials

4,128,880 Total Patients Enrolled

14 Trials studying Ulcerative Colitis

8,652 Patients Enrolled for Ulcerative Colitis

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05076175 — Phase 2 & 3

Ulcerative Colitis Research Study Groups: Ozanimod High Dose, Ozanimod Low Dose

Ulcerative Colitis Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT05076175 — Phase 2 & 3

Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076175 — Phase 2 & 3

Frequently Asked Questions

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

Are we currently recruiting people for this experiment?

"This is an ongoing study that was originally posted on clinicaltrials.gov on 5/30/2022 and has since been updated on 10/25/2022."

Answered by AI

Is Ozanimod a common medication in clinical trials?

"Garden Grove, California is the site of many ongoing ozanimod clinical trials. This research began in 2015 at Local Institution - 554 and there have been a total of 16 completed studies thus far."

Answered by AI

Is this research the first to be conducted on this topic?

"Ozanimod's clinical testing began in 2015 with the first trial being completed that same year. The study was sponsored by Celgene and involved 2350 patients. Based on the success of this initial Phase 3 drug trial, Ozanimod received approval for further clinical trials. Currently, there are 11 active ozanimod trials taking place in 52 countries and 287 cities."

Answered by AI

What medical conditions does Ozanimod help to treat?

"Ozanimod is a common medication used to treat sclerosis, as well as other conditions such as multiple sclerosis, carcinoma in situ, and active secondary progressive multiple sclerosis (spms)."

Answered by AI

How many different locations are conducting this experiment?

"There are 17 available sites for this trial across the United States, including Valley View Wellness Medical Center in Garden Grove, Measurable Outcomes Research in Oklahoma City, and Cedars-Sinai Medical Center in Los Angeles."

Answered by AI

Do I fit the profile of patients that this trial is looking for?

"This study is recruiting 120 people, within the ages of 2 and 17 who have colitis, ulcerative. It is required that patients also meet the following criteria: Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy, Moderately to severely active Ulcerative colitis (UC) diagnosed prior to the Screening Visit, Evidence of UC extending beyond the rectum as determined by baseline endoscopy."

Answered by AI

Do octogenarians qualify for this experiment?

"Children aged 2 to 17 are eligible for this clinical trial, which is one of 67 trials specifically designed for minors. In contrast, there are 363 clinical trials available for senior citizens."

Answered by AI

How many people are being monitored as part of this experiment?

"Yes, the data on clinicaltrials.gov suggests that this study is currently searching for participants. The trial was first posted on 5/30/2022 and was most recently updated on 10/25/2022. The study is enrolling 120 patients at 17 sites across the United States of America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

2022. "A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076175.

All > Ulcerative Colitis > Colitis