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Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease in Pediatric Participants

Local Institution - 0047, Brussel, Belgium
OzanimodPhase 2 & 3RecruitingResearch Sponsored by Bristol-Myers Squibb

Study Summary

This trial will study if ozanimod is effective, safe, and has desired drug levels and effects in children with Crohn's Disease.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have tried and failed to get better with different types of medication for Crohn's Disease, including steroids, immunomodulators, biologics or other therapies.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12, week 64, and up to 81 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12, week 64, and up to 81 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point
Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10
Secondary outcome measures
Absolute change from Baseline in absolute lymphocyte count (ALC)
Change from Baseline in stool frequency score over time
Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)
+17 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734
Upper Respiratory Tract Infection
Alanine Aminotransferase Increased
Influenza Like Illness
Orthostatic Hypotension
Urinary Tract Infection
Gamma-Glutamyltransferase Increased
Study treatment Arm
Ozanimod 0.5 mg
Ozanimod 1 mg
Interferon Beta-1a

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ozanimod Dose Level 2Experimental Treatment1 Intervention
Group II: Ozanimod Dose Level 1Experimental Treatment1 Intervention
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,603 Previous Clinical Trials
4,048,151 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05470985 — Phase 2 & 3
Crohn's Disease Research Study Groups: Ozanimod Dose Level 1, Ozanimod Dose Level 2
Crohn's Disease Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT05470985 — Phase 2 & 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470985 — Phase 2 & 3

Frequently Asked Questions

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

Does this research include middle-aged or older individuals?

"This clinical trial requires participants to be between 2 and 17 years old."

Answered by AI

Are there any current openings for patients who wish to participate in this research?

"The clinical trial in question is not presently recruiting patients, as indicated by information found on clinicaltrials.gov. This study was first posted on October 27th, 2022 and last updated on November 4th, 2022. There are 258 other trials that are actively looking for participants."

Answered by AI

Are there specific eligibility requirements for participants in this research?

"Eligibility criteria for this study includes having ileocolitis and being between the ages of 2-17. The trial plans to enroll around 120 patients in total."

Answered by AI

Are there a great deal of sites running this experiment in the city?

"Currently, University of Iowa Stead Family Children's Hospital in Iowa City, Valley Medical Group (VMG) - Pediatric Gastroenterology in Paramus, and Children's Hospital Coloradof Iowa Stead Family Children's Hospital in Iowa City, Valley Medical Group (VMG) - Pediatric Gastroenterology in Paramus, and Children's Hospital Colorado in Aurora are enrolling patients for this clinical trial. There are also 7 other locations where this study is being conducted."

Answered by AI
~80 spots leftby Sep 2026