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Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Verified Trial
Phase 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Crohn's disease?
Have you previously tried a treatment for Crohn's disease which didn't work?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial

Summary

This trial is testing if ozanimod can help control Crohn's Disease.

Who is the study for?
This trial is for people with moderately to severely active Crohn's Disease who have tried other treatments that didn't work. It's not for those with ulcerative colitis or conditions that might exclude them from safely participating.
What is being tested?
The study tests ozanimod, an oral medication, as a maintenance therapy against a placebo (a pill without the active drug) to see if it helps keep Crohn's Disease under control.
What are the potential side effects?
Ozanimod may cause side effects like headaches, high blood pressure, liver issues, and could increase the risk of infections due to its immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Crohn's disease.
Select...
I have tried a treatment for Crohn's disease that didn't work.
Select...
I do not have ulcerative colitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score of < 150
Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%
Secondary study objectives
Histologic improvement based on differences between ozanimod and placebo in histologic diseaseactivity scores (ie, Global Histologic Disease Activity Score [GHAS] changes)
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50%
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150
+13 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734
49%
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OzanimodExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 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?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,955 Total Patients Enrolled
Jerry Liu, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,565 Previous Clinical Trials
3,383,510 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03464097 — Phase 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03464097 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03464097 — Phase 3
~24 spots leftby Mar 2025
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