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Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

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
Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 264 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for Crohn's Disease.

Who is the study for?
This trial is for people with moderate to severe Crohn's Disease who have finished a previous ozanimod study but are not in remission or response after 12 weeks, or those who relapsed post-study. Participants should not have untreated abscesses and must not be on certain drugs like CYP2C8 inducers or MAO inhibitors.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug called Ozanimod for individuals with Crohn's Disease. It extends prior research by continuing treatment with this medication to see how well it works over a longer period.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, Ozanimod may generally cause infections, liver problems, blood pressure changes, breathing issues, and heart rate irregularities based on its action in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve after 12 weeks in the initial treatment study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 264 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 264 weeks 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 CDAI score of < 150
Secondary outcome measures
Change from baseline in CDAI
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150
Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50%
+9 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

1Treatment groups
Experimental Treatment
Group I: Administration of oral OzanimodExperimental Treatment1 Intervention
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks
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
127,771 Total Patients Enrolled
Kanthi Kollengode, MDStudy DirectorCelgene
3 Previous Clinical Trials
1,269 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,368,797 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03467958 — Phase 3
Crohn's Disease Research Study Groups: Administration of oral Ozanimod
Crohn's Disease Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT03467958 — Phase 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03467958 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03467958 — Phase 3

Frequently Asked Questions

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

Would someone my age be able to participate in this research?

"To be eligible for this study, participants must be between 18-75 years old."

Answered by AI

For whom is this study seeking participants?

"This Bristol-Myers Squibb Clinical Trial is looking for 1200 ileocolitis patients aged 18-75 who have relapsed or completed the Maintenance Study. Additionally, candidates must not be in clinical response or remission after 12 weeks in the Induction Studies. www.BMSStudyConnect.com has more information about participation."

Answered by AI

How does this clinical trial compare to others like it?

"As of now, there are 11 ongoing Ozanimod trials in 52 countries and 287 cities. The very first trial happened in 2015 and was sponsored by Celgene. That particular study had 2350 participants and completed Phase 3 drug approval. In the years since 2015, 16 more trials have taken place."

Answered by AI

Can you tell me how many people can join this clinical trial?

"The sponsor, Celgene, needs to recruit 1200 eligible patients from various clinical trial sites in order to collect the desired data. For example, there are 273 patients at the Local Institution in Calgary, Alberta and University of Utah School of Medicine in Salt Lake City, Utah."

Answered by AI

How many medical facilities are conducting this trial currently?

"There are one hundred sites administering this study globally, with nearby locations in Calgary, Salt Lake City and Glen Burnie. To minimize travel, please select the site nearest you when enrolling."

Answered by AI

Ozanimod is often prescribed for which condition?

"Ozanimod is a medication used to treat sclerosis and other conditions like multiple sclerosis, carcinoma in situ, and active secondary progressive multiple sclerosis (spms)."

Answered by AI

Are there any other scientific papers that mention Ozanimod?

"Ozanimod is being researched in 11 different clinical trials, 9 of which are in the third stage. Most of the research regarding Ozanimod is conducted in Athens, California; although, there are 3726 different research sites for this medication."

Answered by AI

Is this research program still enrolling individuals?

"Yes, this is an ongoing clinical trial that was originally posted on August 24th, 2018. The listing was updated on October 25th, 2020 and is seeking 1200 participants from 100 locations."

Answered by AI

What are the side effects of Ozanimod that people should be aware of?

"Ozanimod, which is currently in Phase 3 clinical trials, has received a safety score of 3. This is due to the efficacy data supporting its safety as well as multiple rounds of safety data."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Valley View Internal Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

For test trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
2018. "An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03467958.
All > New Mexico > Paid Studies Arkansas
~653 spots leftby Dec 2030
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