Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Mayo Clinic, Rochester, MN
Ozanimod +1 morePhase 3RecruitingResearch Sponsored by Celgene

Study Summary

This trial is testing a new drug to see if it can help people with Crohn's Disease.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You cannot have ulcerative colitis.
Previous treatments with drugs like corticosteroids, immunomodulators or biologics did not work or stopped working.
Previous treatments with corticosteroids, immunomodulators, and/or biologic therapy did not work or stopped working.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 < 150
Secondary outcome measures
Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50%
+8 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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of oral OzanimodExperimental Treatment1 Intervention
Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation
Group II: Administration of PlaceboPlacebo Group1 Intervention
Subjects will receive placebo capsule orally starting with a 7-day dose escalation
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

CelgeneLead Sponsor
627 Previous Clinical Trials
125,731 Total Patients Enrolled
Bristol-Myers SquibbStudy Director
Bristol-Myers Squibb
1,451 Previous Clinical Trials
3,314,737 Total Patients Enrolled
Kanthi Kollengode, MDStudy Director
Celgene Corporation
3 Previous Clinical Trials
1,869 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03440385 — Phase 3
Crohn's Disease Research Study Groups: Administration of Placebo, Administration of oral Ozanimod
Crohn's Disease Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT03440385 — Phase 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03440385 — Phase 3

Frequently Asked Questions

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

Are there any safety concerns associated with Ozanimod?

"Ozanimod has some efficacy data from previous trials, and multiple rounds of safety testing have been completed, so it received a score of 3."

Answered by AI

Are there any other similar trials to this one that have been conducted in the past?

"There have been 11 ongoing studies for Ozanimod in 52 countries and 287 cities since 2015. The first study, sponsored by Celgene, was completed in Phase 3 drug approval stage with 2350 participants."

Answered by AI

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

"This clinical trial is presently enrolling patients at 77 sites. The locations are located in San Francisco, Bristol and Decatur as well as 77 other locations. It is important to select the site closest you so that you can minimize travel demands if you enroll."

Answered by AI

To what demographics does this research pertain?

"Ileocolitis patients, between the ages of 18-75, who meet the following medical criteria are encouraged to apply: Must not have ulcerative colitis, an inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy."

Answered by AI

What is the research history of Ozanimod?

"Ozanimod was first studied in the year 2015 at Local Institution - 554. Out of the 18302 completed trials, 11 are ongoing with many taking place in San Francisco, California."

Answered by AI

How many participants are being allowed in this experiment?

"Yes, you are correct. The clinical trial was originally posted on 3/7/2018 and was last updated on 11/15/2022. The study is enrolling 600 patients across 77 sites."

Answered by AI

Will this research be able to accommodate patients that are over 35 years old?

"The age range for eligible patients in this study is between 18 and 75 years old."

Answered by AI

What are the main health concerns that Ozanimod has been shown to improve?

"Ozanimod is a medication that can help patients suffering from sclerosis, multiple sclerosis, and carcinoma in situ."

Answered by AI

Are we still enrolling participants for this research project?

"The trial is still ongoing and recruiting patients, according to the information provided on The listing for the study was first posted on March 7th, 2018 with the most recent update being from November 15th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
North Carolina
How old are they?
18 - 65
What site did they apply to?
Galiz Research LLC
PMG Research of Charlotte LLC
PMG Research of Winston-Salem LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

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
~42 spots leftby Mar 2024