Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: Ozanimod is often prescribed for which condition?

Ozanimod is a medication used to treat sclerosis and other conditions like <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, carcinoma in situ, and active secondary progressive multiple sclerosis (spms).

Q: 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.

Q: 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.

Q: 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.

Local Institution - 563, Kyiv, Ukraine

OzanimodPhase 3RecruitingResearch 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

Experience relapse or who complete the Maintenance Study

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 264 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Study Summary

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

Eligibility Criteria

Inclusion Criteria

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

Select...

You did not show improvement or recovery after participating in the initial 12-week treatment phase.

Select...

You have had a recurrence of your condition or have completed a previous study for maintenance treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 264 weeks

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

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

FDA approved

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

CelgeneLead Sponsor

627 Previous Clinical Trials

125,131 Total Patients Enrolled

Kanthi Kollengode, MDStudy Director

Celgene

3 Previous Clinical Trials

1,269 Total Patients Enrolled

Bristol-Myers SquibbStudy Director

Bristol-Myers Squibb

1,451 Previous Clinical Trials

3,314,137 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