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Sphingosine 1-phosphate receptor modulator

Ozanimod for Ulcerative Colitis

Phase 4
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with specific subscores met
A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
Must not have
Colonic dysplasia that has not been removed
Extensive colonic resection or current stoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying how well a medication works in people with ulcerative colitis in real-world settings.

Who is the study for?
This trial is for people with moderate to severe ulcerative colitis, confirmed by a colonoscopy within the last 60 days. Participants should have active symptoms for at least 3 months and meet specific disease activity scores. Those with recent severe complications, major surgery on the colon, or unremoved colonic dysplasia cannot join.
What is being tested?
The study is testing Ozanimod's effects on safety, effectiveness in controlling UC symptoms, impact on quality of life, and changes in biomarkers that indicate disease activity among patients as they receive treatment during regular clinical care.
What are the potential side effects?
While not specified here, common side effects of Ozanimod may include headaches, upper respiratory infections, high blood pressure, liver enzyme elevations, and potential increase in risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe, based on a specific score.
Select...
I have been diagnosed with ulcerative colitis for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have abnormal colon cells that haven't been removed.
Select...
I have had a major surgery to remove part of my colon or I currently have a stoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical response as measured by modified Mayo score
Secondary study objectives
Clinical remission as measured by modified Mayo score
Clinical remission by partial Mayo score
Clinical response by partial Mayo score
+16 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

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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

2Treatment groups
Experimental Treatment
Group I: Cohort 2 - Advanced therapy-exposedExperimental Treatment1 Intervention
Group II: Cohort 1 - Advanced therapy-naiveExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,129,361 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
8,530 Patients Enrolled for Ulcerative Colitis

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05369832 — Phase 4
Ulcerative Colitis Research Study Groups: Cohort 1 - Advanced therapy-naive, Cohort 2 - Advanced therapy-exposed
Ulcerative Colitis Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT05369832 — Phase 4
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369832 — Phase 4
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05369832 — Phase 4
~156 spots leftby Sep 2025
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