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Sphingosine 1-phosphate receptor modulator

Oral 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
Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
Crohn's disease for ≥ 3 months on endoscopy and on histological exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help Crohn's Disease patients who are in moderate to severe pain.

Who is the study for?
This trial is for people with moderate to severe Crohn's Disease who haven't had success with steroids, immunomodulators, or biologics. They should have a certain level of disease activity and inflammation in the intestines. It's not for those with a stoma, extensive bowel surgery, or other types of colitis.Check my eligibility
What is being tested?
The study tests oral ozanimod as an initial treatment against a placebo to see how effective it is in reducing symptoms of Crohn's Disease. Participants will be randomly assigned to receive either the medication or placebo.See study design
What are the potential side effects?
Ozanimod may cause side effects like headaches, high blood pressure, liver enzyme elevations, and respiratory infections. There might also be potential risks related to immune system changes since ozanimod affects immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Crohn's disease is active but not extremely severe.
Select...
I have been diagnosed with Crohn's disease for at least 3 months.
Select...
I experience frequent bowel movements or significant abdominal pain daily.
Select...
My condition didn't improve with steroids, immune treatments, or biologics.

Timeline

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 (ie, Global Histologic Disease Activity Score changes)
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 and SES-CD decrease from baseline of ≥ 50%
+8 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

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
2020
Completed Phase 3
~3510

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,371 Total Patients Enrolled
Kanthi Kollengode, MDStudy DirectorCelgene Corporation
3 Previous Clinical Trials
1,869 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,397 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03440372 — 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: NCT03440372 — Phase 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03440372 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03440372 — Phase 3

Frequently Asked Questions

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

For what medical condition is Ozanimod most commonly prescribed?

"Ozanimod is an effective intervention for treating sclerosis, multiple sclerosis, and carcinoma in situ."

Answered by AI

Do numerous hospitals in the United States have this trial underway?

"Select patients are being accepted at 64 different hospitals and research institutes across America, such as Northwestern University in Chicago, Illinois, Sun Research Institute in San Antonio, Texas, and Medical University Of South carolina in Charleston, South Carolina."

Answered by AI

What makes this test unique compared to others like it?

"Ozanimod has undergone extensive research since first being studied in 2015. A Phase 3 drug approval was received following the initial 2350 person trial sponsored by Celgene. As of now, there are 11 active studies taking place across 52 countries and 287 cities."

Answered by AI

Are there any patients who have not yet been enrolled in this research project?

"That is correct, the online clinicaltrials.gov database indicates that this research project is currently looking for volunteers. The trial was first announced on February 27th 2018 with the latest update being November 8th 2022. So far, 64 different hospitals or clinics have agreed to participate and help recruit the 600 patients needed."

Answered by AI

How many study participants are there in total?

"In order to move forward, this clinical trial requires 600 patients that fit the bill in terms of age, health, and other inclusion criteria. Participating patients will visit one of many sites - two examples being Northwestern University located in Chicago, Illinois or Sun Research Institute based in San Antonio, Texas."

Answered by AI

Could I qualify to take part in this research?

"This study is seeking 600 individuals that suffer from ileocolitis and meet the following conditions: being between 18-75 years old, a Crohn's disease Activity Index (CDAI) score of ≥ 220 and ≤ 450, a Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease),Crohn's disease present on endoscopy and histological exam for 3 months or more, an average daily stool frequency ≥ 4 points and/or abdominal pain of ≥ 2 points, inadequately responsive or"

Answered by AI

What is the historical data on Ozanimod's clinical efficacy?

"Ozanimod was first studied in 2015 at Local Institution - 554. There have been 18302 completed studies since then, with 11 more ongoing trials. Of these active studies, a few are based in Chicago, Illinois."

Answered by AI

Does this research include middle-aged or elderly participants?

"According to the study's eligibility requirements, patients must be aged 18-75. There are currently 70 trials underway for patients that are underaged and 206 for senior citizens."

Answered by AI

What are some of the potential dangers associated with Ozanimod?

"Ozanimod's safety is based on Phase 3 clinical trial data, and it has received a score of 3 from our analysts."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried a couple meds,to no avail.i have also had my large intestine removed to remove the Crohn's,nine years later,it resurfaced.i still have an illeostomy bag as well.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
2018. "Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03440372.
All > New Mexico > Paid Studies Arkansas
~59 spots leftby Dec 2024
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