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Ulcerative colitis drug study halted early

NCT ID NCT05369832

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety and effectiveness of the drug ozanimod for people with moderate to severe ulcerative colitis. It aimed to see if the drug could improve symptoms like diarrhea and rectal bleeding, and how it affected quality of life. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

139 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration). * Report of a previous colonoscopy that documents extent of disease Exclusion Criteria: * Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation * Extensive colonic resection or current stoma * Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

Contacts and locations

Locations

  • Ace Clinical Research Group: Digestive Health Associates

    Houston, Texas, 77024, United States

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834-3761, United States

  • GI Alliance: Mansfield - TDDC

    Mansfield, Texas, 76063-6083, United States

  • Gastro Florida

    Clearwater, Florida, 33756-3839, United States

  • Gastroenterology Group of Naples

    Naples, Florida, 34102-5449, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Local Institution - 0002

    San Diego, California, 92103-5639, United States

  • Local Institution - 0003

    Naples, Florida, 34102-5449, United States

  • Local Institution - 0005

    Cincinnati, Ohio, 45229-3019, United States

  • Local Institution - 0014

    Lancaster, California, 93534-5856, United States

  • Local Institution - 0017

    Madison, Wisconsin, 53705-1311, United States

  • Local Institution - 0018

    Clearwater, Florida, 33756-3839, United States

  • Local Institution - 0024

    Chesterfield, Missouri, 63005-1248, United States

  • Local Institution - 0026

    Lighthouse PT, Florida, 33064-7058, United States

  • Local Institution - 0027

    Roswell, Georgia, 30076-4969, United States

  • Local Institution - 0036

    Houston, Texas, 77024-2469, United States

  • Local Institution - 0037

    Palm Harbor, Florida, 34684, United States

  • Local Institution - 0038

    Bellaire, Texas, 77401, United States

  • Local Institution - 0039

    Mansfield, Texas, 76063-6083, United States

  • Local Institution - 0043

    San Antonio, Texas, 78229-4463, United States

  • Local Institution - 0045

    North Little Rock, Arkansas, 72117-2927, United States

  • Local Institution - 0046

    Tyler, Texas, 75701-4464, United States

  • Local Institution - 0048

    Dothan, Alabama, 36305-1156, United States

  • Local Institution - 0049

    Miami Lakes, Florida, 33016-5861, United States

  • Local Institution - 0050

    Homestead, Florida, 33033, United States

  • Local Institution - 0051

    Chicago, Illinois, 60611, United States

  • Local Institution - 0052

    Houston, Texas, 77030, United States

  • Local Institution - 0058

    Orange Park, Florida, 32073-4752, United States

  • Local Institution - 0059

    New York, New York, 10016-9401, United States

  • Local Institution - 0060

    Providence, Rhode Island, 02905-3105, United States

  • Local Institution - 0061

    Mentor, Ohio, 44060-6521, United States

  • Local Institution - 0084

    Brooklyn, New York, 11203-2054, United States

  • Local Institution - 0091

    Webster, Texas, 77598, United States

  • Local Institution - 0098

    Gurnee, Illinois, 60031, United States

  • Local Institution - 0125

    Sun City, Arizona, 85351-2867, United States

  • Local Institution - 0129

    Katy, Texas, 77494, United States

  • Local Institution - 0130

    Seattle, Washington, 98104-1356, United States

  • Local Institution - 0138

    Dallas, Texas, 75246, United States

  • Local Institution - 0161

    Lubbock, Texas, 79410-2014, United States

  • Local Institution - 0162

    Camarillo, California, 93012-5156, United States

  • Local Institution - 0163

    Houston, Texas, 77024-2469, United States

  • Local Institution - 0165

    Apple Valley, California, 92307-1329, United States

  • Local Institution - 0166

    San Marcos, Texas, 78666-7502, United States

  • Local Institution - 0167

    Miami, Florida, 33136-1002, United States

  • Local Institution - 0168

    Nashville, Tennessee, 37211-4981, United States

  • Local Institution - 0169

    Salt Lake City, Utah, 84132-0001, United States

  • Local Institution - 0170

    Utica, New York, 13502, United States

  • Local Institution - 0171

    Chevy Chase, Maryland, 20815-7313, United States

  • Local Institution - 0174

    Plymouth, Minnesota, 55446-3661, United States

  • Local Institution - 0176

    New York, New York, 10021, United States

  • Local Institution - 0177

    Cordova, Tennessee, 38018-6362, United States

  • Local Institution - 0178

    Littleton, Colorado, 80120-5641, United States

  • Local Institution - 0179

    Wellington, Florida, 33414-3187, United States

  • Local Institution - 0180

    Englewood, New Jersey, 07631-4141, United States

  • Local Institution - 0181

    Topeka, Kansas, 66606-1539, United States

  • Local Institution - 0183

    Louisville, Kentucky, 40202, United States

  • Local Institution - 0184

    Ocean Springs, Mississippi, 39564-5803, United States

  • Local Institution - 0185

    San Jose, California, 95116, United States

  • Local Institution - 0187

    New York, New York, 10016-6821, United States

  • Local Institution - 0188

    Columbus, Ohio, 43235-5424, United States

  • Local Institution - 0189

    Tacoma, Washington, 98405-2318, United States

  • Local Institution - 0191

    Glen Burnie, Maryland, 21061-9121, United States

  • Local Institution - 0192

    Kansas City, Kansas, 66160-8500, United States

  • Local Institution - 0193

    Ogden, Utah, 84403-3294, United States

  • Local Institution - 0195

    Tucson, Arizona, 85724-0001, United States

  • Local Institution - 0196

    Worcester, Massachusetts, 01655, United States

  • Local Institution - 0197

    Lynchburg, Virginia, 24502, United States

  • Local Institution - 0198

    Arlington Heights, Illinois, 60005, United States

  • Local Institution - 0199

    Boston, Massachusetts, 02111, United States

  • Local Institution - 0200

    Baton Rouge, Louisiana, 70809-2440, United States

  • Local Institution - 0201

    San Antonio, Texas, 78229-3270, United States

  • Local Institution - 0205

    Orlando, Florida, 32806-1110, United States

  • Local Institution - 0206

    Chandler, Arizona, 85224-1636, United States

  • Local Institution - 0208

    San Diego, California, 92123-4207, United States

  • Local Institution - 0209

    Los Angeles, California, 90045-3119, United States

  • Local Institution - 0213

    Weldon Spring, Missouri, 63304-9103, United States

  • Local Institution - 0216

    Gilbert, Arizona, 85297-0425, United States

  • NYU Langone Health -Inflammatory Bowel Disease Center

    New York, New York, 10016-9401, United States

  • Novel Research LLC

    Bellaire, Texas, 77401, United States

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California, 93534-5856, United States

  • San Antonio Gastroenterology

    San Antonio, Texas, 78229-4463, United States

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701-4464, United States

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio, 45229-3019, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

  • Wellness Clinical Research-Miami Florida

    Miami Lakes, Florida, 33016-5861, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.