Verified

Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Q: 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.

Q: 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.

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, an inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy.

Q: 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.

Q: 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.

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

The age <a href="https://www.withpower.com/clinical-trials/ra">ra</a>nge for eligible patients in this study is between 18 and 75 years old.

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

Ozanimod is a medication that can help patients suffering from sclerosis, <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, and carcinoma in situ.

Q: Are we still enrolling participants for this research project?

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

Mayo Clinic, Rochester, MN

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

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

Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upweek 12

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

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

Select...

You cannot have ulcerative colitis.

Select...

Previous treatments with drugs like corticosteroids, immunomodulators or biologics did not work or stopped working.

Select...

Previous treatments with corticosteroids, immunomodulators, and/or biologic therapy did not work or stopped working.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

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

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

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

125,731 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 clinicaltrials.gov. 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