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Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease in Pediatric Participants

Q: Does this research include middle-aged or older individuals?

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

Q: 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.

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a><a href="https://www.withpower.com/clinical-trials/iowa">f Io</a>wa 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.

Local Institution - 0047, Brussel, Belgium

OzanimodPhase 2 & 3RecruitingResearch Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score ≥ 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD): i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upat week 12, week 64, and up to 81 weeks

Awards & highlights

No Placebo-Only Group

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

Select...

You have tried and failed to get better with different types of medication for Crohn's Disease, including steroids, immunomodulators, biologics or other therapies.

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

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

13%

Headache

13%

Nasopharyngitis

Upper Respiratory Tract Infection

Alanine Aminotransferase Increased

Influenza Like Illness

Orthostatic Hypotension

Urinary Tract Infection

Pharyngitis

Hypertension

Gamma-Glutamyltransferase Increased

Pyrexia

100%

80%

60%

40%

20%

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

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

2,603 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 Colorado f 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

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

2023. "A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470985.

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