An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

NCT05369832 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IM047-029
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 85

Brief Summary

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative Colitis; Ozanimod; RPC-1063; Zeposia®; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12

  Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition.

  At week 12

• Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26

  Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition.

  At week 26

Secondary Outcomes (26)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days)

• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

  From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days)

• Number of Participants With Treatment Emergent Adverse Event of Interest

  From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days)

• Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation

  From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days)

• Number of Participants With Clinically Significant Changes in Laboratory Assessments

  From first dose of study medication through end of study (Up to approximately 728 days)

Study Arms (2)

Cohort 1 - Advanced therapy-naive

EXPERIMENTAL

Drug: Ozanimod

Cohort 2 - Advanced therapy-exposed

EXPERIMENTAL

Drug: Ozanimod

Interventions

Ozanimod DRUG

Specified dose on specified days

Also known as: Zeposia®, RPC-1063, BMS-986374

Cohort 1 - Advanced therapy-naive; Cohort 2 - Advanced therapy-exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (85)

Local Institution - 0048

Dothan, Alabama, 36305-1156, United States

Location

Local Institution - 0206

Chandler, Arizona, 85224-1636, United States

Location

Local Institution - 0216

Gilbert, Arizona, 85297-0425, United States

Location

Local Institution - 0125

Sun City, Arizona, 85351-2867, United States

Location

Local Institution - 0195

Tucson, Arizona, 85724-0001, United States

Location

Local Institution - 0045

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

Location

Local Institution - 0165

Apple Valley, California, 92307-1329, United States

Location

Local Institution - 0162

Camarillo, California, 93012-5156, United States

Location

Local Institution - 0014

Lancaster, California, 93534-5856, United States

Location

OM Research LLC - Lancaster - ClinEdge - PPDS

Lancaster, California, 93534-5856, United States

Location

Local Institution - 0209

Los Angeles, California, 90045-3119, United States

Location

Local Institution - 0002

San Diego, California, 92103-5639, United States

Location

Local Institution - 0208

San Diego, California, 92123-4207, United States

Location

Local Institution - 0185

San Jose, California, 95116, United States

Location

Local Institution - 0178

Littleton, Colorado, 80120-5641, United States

Location

Gastro Florida

Clearwater, Florida, 33756-3839, United States

Location

Local Institution - 0018

Clearwater, Florida, 33756-3839, United States

Location

Local Institution - 0050

Homestead, Florida, 33033, United States

Location

Local Institution - 0026

Lighthouse PT, Florida, 33064-7058, United States

Location

Local Institution - 0167

Miami, Florida, 33136-1002, United States

Location

Local Institution - 0049

Miami Lakes, Florida, 33016-5861, United States

Location

Wellness Clinical Research-Miami Florida

Miami Lakes, Florida, 33016-5861, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102-5449, United States

Location

Local Institution - 0003

Naples, Florida, 34102-5449, United States

Location

Local Institution - 0058

Orange Park, Florida, 32073-4752, United States

Location

Local Institution - 0205

Orlando, Florida, 32806-1110, United States

Location

Local Institution - 0037

Palm Harbor, Florida, 34684, United States

Location

Local Institution - 0179

Wellington, Florida, 33414-3187, United States

Location

Local Institution - 0027

Roswell, Georgia, 30076-4969, United States

Location

Local Institution - 0198

Arlington Heights, Illinois, 60005, United States

Location

Local Institution - 0051

Chicago, Illinois, 60611, United States

Location

Local Institution - 0098

Gurnee, Illinois, 60031, United States

Location

Local Institution - 0192

Kansas City, Kansas, 66160-8500, United States

Location

Local Institution - 0181

Topeka, Kansas, 66606-1539, United States

Location

Local Institution - 0183

Louisville, Kentucky, 40202, United States

Location

Local Institution - 0200

Baton Rouge, Louisiana, 70809-2440, United States

Location

Local Institution - 0171

Chevy Chase, Maryland, 20815-7313, United States

Location

Local Institution - 0191

Glen Burnie, Maryland, 21061-9121, United States

Location

Local Institution - 0199

Boston, Massachusetts, 02111, United States

Location

Local Institution - 0196

Worcester, Massachusetts, 01655, United States

Location

Local Institution - 0174

Plymouth, Minnesota, 55446-3661, United States

Location

Local Institution - 0184

Ocean Springs, Mississippi, 39564-5803, United States

Location

Local Institution - 0024

Chesterfield, Missouri, 63005-1248, United States

Location

Local Institution - 0213

Weldon Spring, Missouri, 63304-9103, United States

Location

Local Institution - 0180

Englewood, New Jersey, 07631-4141, United States

Location

Local Institution - 0084

Brooklyn, New York, 11203-2054, United States

Location

Local Institution - 0187

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

Location

Local Institution - 0059

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

Location

NYU Langone Health -Inflammatory Bowel Disease Center

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

Location

Local Institution - 0176

New York, New York, 10021, United States

Location

Local Institution - 0170

Utica, New York, 13502, United States

Location

Carolina Digestive Diseases

Greenville, North Carolina, 27834-3761, United States

Location

Local Institution - 0005

Cincinnati, Ohio, 45229-3019, United States

Location

University of Cincinnati Physicians Company

Cincinnati, Ohio, 45229-3019, United States

Location

Local Institution - 0188

Columbus, Ohio, 43235-5424, United States

Location

Local Institution - 0061

Mentor, Ohio, 44060-6521, United States

Location

Local Institution - 0060

Providence, Rhode Island, 02905-3105, United States

Location

Local Institution - 0177

Cordova, Tennessee, 38018-6362, United States

Location

Local Institution - 0168

Nashville, Tennessee, 37211-4981, United States

Location

Local Institution - 0038

Bellaire, Texas, 77401, United States

Location

Novel Research LLC

Bellaire, Texas, 77401, United States

Location

Local Institution - 0138

Dallas, Texas, 75246, United States

Location

Local Institution - 0036

Houston, Texas, 77024-2469, United States

Location

Local Institution - 0163

Houston, Texas, 77024-2469, United States

Location

Ace Clinical Research Group: Digestive Health Associates

Houston, Texas, 77024, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Local Institution - 0052

Houston, Texas, 77030, United States

Location

Local Institution - 0129

Katy, Texas, 77494, United States

Location

Local Institution - 0161

Lubbock, Texas, 79410-2014, United States

Location

GI Alliance: Mansfield - TDDC

Mansfield, Texas, 76063-6083, United States

Location

Local Institution - 0039

Mansfield, Texas, 76063-6083, United States

Location

Local Institution - 0201

San Antonio, Texas, 78229-3270, United States

Location

Local Institution - 0043

San Antonio, Texas, 78229-4463, United States

Location

San Antonio Gastroenterology

San Antonio, Texas, 78229-4463, United States

Location

Local Institution - 0166

San Marcos, Texas, 78666-7502, United States

Location

Local Institution - 0046

Tyler, Texas, 75701-4464, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701-4464, United States

Location

Local Institution - 0091

Webster, Texas, 77598, United States

Location

Local Institution - 0193

Ogden, Utah, 84403-3294, United States

Location

Local Institution - 0169

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

Location

Local Institution - 0197

Lynchburg, Virginia, 24502, United States

Location

Local Institution - 0130

Seattle, Washington, 98104-1356, United States

Location

Local Institution - 0189

Tacoma, Washington, 98405-2318, United States

Location

Local Institution - 0017

Madison, Wisconsin, 53705-1311, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: December 16, 2022
• Primary Completion: January 21, 2025
• Study Completion: April 11, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-02

Locations

US (85)