Verified

Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>?.

Q: 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.

Q: What are the most common medical reasons for Ozanimod treatments?

Ozanimod is frequently used to manage sclerosis, but can <a href="https://www.withpower.com/clinical-trials/als">als</a>o help patients that have been diagnosed with <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, carcinoma in situ, or active secondary progressive multiple sclerosis (spms).

Q: 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.

Q: 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).

Q: 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.

Q: 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.

Q: 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.

Local Institution - 392, Santiago, Chile

Ozanimod +1 morePhase 3RecruitingResearch 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?

Please confirm that you do *not* have ulcerative colitis?

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upweek 52

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have been diagnosed with Crohn's disease.

Select...

You cannot have ulcerative colitis.

Select...

You have tried a treatment for Crohn's disease before that did not help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

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

13%

Nasopharyngitis

13%

Headache

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

FDA approved

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

CelgeneLead Sponsor

627 Previous Clinical Trials

125,846 Total Patients Enrolled

Jerry Liu, MDStudy Director

Celgene Corporation

Bristol-Myers SquibbStudy Director

Bristol-Myers Squibb

1,451 Previous Clinical Trials

3,314,852 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