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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
636 Previous Clinical Trials
128,369 Total Patients Enrolled
Jerry Liu, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,338 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

Frequently Asked Questions

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

Are new participants still being sought for this clinical trial?

"That is accurate. The clinical trial in question, which was initially posted on June 27th 2018 according to clinicaltrials.gov, currently has an open call for 485 participants at 100 locations."

Answered by AI

How can I qualify to take part in this research?

"Researchers conducting this trial are looking for 485 individuals that have ileocolitis and are between 18-75 years old. Most importantly, applicants should answer the following questions affirmatively: Have you been diagnosed with Crohn's disease?, Have you previously tried a treatment for Crohn's disease which didn't work?, Please confirm that you do not have ulcerative colitis?."

Answered by AI

In how many different geographical areas is this trial taking place?

"With 100 hospitals participating, this study has widespread reach. Some of the notable locations include University of Minnesota Medical Center in Minneapolis, NY Scientific in Brooklyn, and University of California at San Francisco in San Francisco."

Answered by AI

What are the most common medical reasons for Ozanimod treatments?

"Ozanimod is frequently used to manage sclerosis, but can also help patients that have been diagnosed with multiple sclerosis, carcinoma in situ, or active secondary progressive multiple sclerosis (spms)."

Answered by AI

How many people are being observed for this research project?

"In order to successfully conduct this research, 485 eligible individuals are required to participate. Those who meet the requirements can sign up at University of Minnesota Medical Center in Minneapolis or NY Scientific in Brooklyn."

Answered by AI

Does this research include test subjects that are over the age of 30?

"Eligibility for this particular trial is restricted to those aged 18-75. There are 70 other trials underway for patients that fall outside of this age bracket (both younger and older)."

Answered by AI

Are there other drugs similar to Ozanimod that have been studied in clinical trials?

"Ozanimod was first studied in 2015 at Local Institution - 554. Since that initial clinical trial, there have been 18302 completed studies. Right now, there are 11 active clinical trials involving ozanimod with a significant number of these occurring in Minneapolis, Minnesota."

Answered by AI

When will Ozanimod be available to the public?

"The safety of Ozanimod is estimated to be a 3 on a scale from 1 to 3. This is because it is a Phase 3 trial, which means that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Has this type of research been conducted before?

"As of right now, there are 11 ongoing Ozanimod trials in 52 countries and 287 cities. The first study was conducted in 2015 by Celgene. That trial completed Phase 3 drug approval with 2350 patients. Since then, 18302 studies have been concluded."

Answered by AI

Who else is applying?

What state do they live in?
California
South Carolina
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
Avant Research Associates, LLC - Austin
PMG Research of Charlotte LLC
PMG Research of Winston-Salem LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

Struggled for years. Hoping to.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. PMG Research of Winston-Salem LLC: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
2018. "A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03464097.
All > New Mexico > Paid Studies Arkansas
~61 spots leftby Mar 2025
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