Your session is about to expire
← Back to Search
Sphingosine 1-phosphate receptor modulator
Ozanimod for Pediatric Crohn's Disease
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12, week 64, and up to 81 weeks
Awards & highlights
Study Summary
This trial will study if ozanimod is effective, safe, and has desired drug levels and effects in children with Crohn's Disease.
Who is the study for?
This trial is for children with moderate to severe Crohn's Disease who haven't responded well to treatments like steroids, immunomodulators, biologics, or other immune therapies. They must have certain scores on disease activity and endoscopy scales. Kids with recent major bowel surgery or those needing it soon can't join.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of an oral medication called Ozanimod in young patients. It aims to see how the drug behaves in their bodies and its impact on Crohn's Disease symptoms.See study design
What are the potential side effects?
Possible side effects of Ozanimod include headache, high blood pressure, liver enzyme changes, respiratory infections, flu-like symptoms, back pain and stomach-area (abdominal) pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 12, week 64, and up to 81 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12, week 64, and up to 81 weeks
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 moreSide effects data
From 2017 Phase 3 trial • 1320 Patients • NCT0204773449%
Influenza Like Illness
12%
Headache
11%
Nasopharyngitis
8%
Upper Respiratory Tract Infection
6%
Orthostatic Hypotension
6%
Pyrexia
5%
Alanine Aminotransferase Increased
4%
Urinary Tract Infection
3%
Hypertension
3%
Pharyngitis
2%
Gamma-Glutamyltransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interferon Beta-1a
Ozanimod 0.5 mg
Ozanimod 1 mg
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ozanimod Dose Level 2Experimental Treatment1 Intervention
Group II: Ozanimod Dose Level 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
2020
Completed Phase 3
~3510
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,129,944 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Crohn's disease is active, with a PCDAI score of 30 or more and an endoscopy score of 6 or more.I have a stoma or similar condition that might need surgery or medical care soon.My doctor thinks I will need surgery to remove part of my intestines soon.I have Crohn's Disease and treatments like steroids or biologics haven’t worked well for me.I have had a major part of my small intestine removed or need nutrition through an IV.
Research Study Groups:
This trial has the following groups:- Group 1: Ozanimod Dose Level 1
- Group 2: Ozanimod Dose Level 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger