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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response as measured by modified Mayo score at Week 12
Secondary outcome measures
Clinical remission as measured by modified Mayo score
Clinical remission by partial Mayo score
Clinical response by partial Mayo score
+16 moreSide effects data
From 2017 Phase 3 trial • 1320 Patients • NCT0204773449%
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
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
2,639 Previous Clinical Trials
4,128,617 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
8,652 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcerative colitis is moderate to severe, based on a specific score.I have abnormal colon cells that haven't been removed.I have had severe colon issues or a bowel tear in the last 3 months.I have been diagnosed with ulcerative colitis for at least 3 months.I have had a major surgery to remove part of my colon or I currently have a stoma.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - Advanced therapy-naive
- Group 2: Cohort 2 - Advanced therapy-exposed
Awards:
This trial has 4 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT05369832 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical institutions are implementing this research experiment?
"This research endeavour is inviting participants from Gastroenterology Associates of Florida (GI Allianc in Wellington, FL), Gastroenterology Consultants, PC in Roswell, GA , Rocky Mountain Gastroenterology (RMG) - Littleton in Littleton, CO and 61 other locations."
Answered by AI
What is the overall aim of this experiment?
"This medical research, which will span a maximum of 26 weeks, is intended to evaluate clinical response through the modified Mayo score. Secondary objectives include determining adverse events in Cohort 1 and 2 patients, histo-endoscopic mucosal improvement exclusively among cohort two individuals, as well as endoscopic responses across both cohorts."
Answered by AI
Are there any remaining slots in this research endeavor for potential participants?
"According to the clinicaltrials.gov portal, this medical trial is not at present recruiting patients; its initial posting was on November 18th 2022 and it lastly updated on 23rd of that same month. Nevertheless, there are 399 other trials actively searching for volunteers right now."
Answered by AI
Is Ozanimod likely to pose any risks or harm when taken by people?
"Ozanimod's safety is deemed reliable and worthy of a score of 3, as it has been approved for human use by the Food and Drug Administration."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Blue Ridge Medical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have been taking Mesalamine for several years now and have recently been experiencing debilitating flare-ups. I would like to try and see what other treatments are out there.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How often are screening visits?
PatientReceived 2+ prior treatments
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