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

A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice

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.

Study Overview

• Status: Terminated
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Ozanimod

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305-1156
      • Local Institution - 0048
  • Arizona
    • Chandler, Arizona, United States, 85224-1636
      • Local Institution - 0206
    • Gilbert, Arizona, United States, 85297-0425
      • Local Institution - 0216
    • Sun City, Arizona, United States, 85351-2867
      • Local Institution - 0125
    • Tucson, Arizona, United States, 85724-0001
      • Local Institution - 0195
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117-2927
      • Local Institution - 0045
  • California
    • Apple Valley, California, United States, 92307-1329
      • Local Institution - 0165
    • Camarillo, California, United States, 93012-5156
      • Local Institution - 0162
    • Lancaster, California, United States, 93534-5856
      • Local Institution - 0014
    • Lancaster, California, United States, 93534-5856
      • OM Research LLC - Lancaster - ClinEdge - PPDS
    • Los Angeles, California, United States, 90045-3119
      • Local Institution - 0209
    • San Diego, California, United States, 92103-5639
      • Local Institution - 0002
    • San Diego, California, United States, 92123-4207
      • Local Institution - 0208
    • San Jose, California, United States, 95116
      • Local Institution - 0185
  • Colorado
    • Littleton, Colorado, United States, 80120-5641
      • Local Institution - 0178
  • Florida
    • Clearwater, Florida, United States, 33756-3839
      • Gastro Florida
    • Clearwater, Florida, United States, 33756-3839
      • Local Institution - 0018
    • Homestead, Florida, United States, 33033
      • Local Institution - 0050
    • Lighthouse PT, Florida, United States, 33064-7058
      • Local Institution - 0026
    • Miami, Florida, United States, 33136-1002
      • Local Institution - 0167
    • Miami Lakes, Florida, United States, 33016-5861
      • Local Institution - 0049
    • Miami Lakes, Florida, United States, 33016-5861
      • Wellness Clinical Research-Miami Florida
    • Naples, Florida, United States, 34102-5449
      • Gastroenterology Group Of Naples
    • Naples, Florida, United States, 34102-5449
      • Local Institution - 0003
    • Orange Park, Florida, United States, 32073-4752
      • Local Institution - 0058
    • Orlando, Florida, United States, 32806-1110
      • Local Institution - 0205
    • Palm Harbor, Florida, United States, 34684
      • Local Institution - 0037
    • Wellington, Florida, United States, 33414-3187
      • Local Institution - 0179
  • Georgia
    • Roswell, Georgia, United States, 30076-4969
      • Local Institution - 0027
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Local Institution - 0198
    • Chicago, Illinois, United States, 60611
      • Local Institution - 0051
    • Gurnee, Illinois, United States, 60031
      • Local Institution - 0098
  • Kansas
    • Kansas City, Kansas, United States, 66160-8500
      • Local Institution - 0192
    • Topeka, Kansas, United States, 66606-1539
      • Local Institution - 0181
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Local Institution - 0183
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809-2440
      • Local Institution - 0200
  • Maryland
    • Chevy Chase, Maryland, United States, 20815-7313
      • Local Institution - 0171
    • Glen Burnie, Maryland, United States, 21061-9121
      • Local Institution - 0191
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Local Institution - 0199
    • Worcester, Massachusetts, United States, 01655
      • Local Institution - 0196
  • Minnesota
    • Plymouth, Minnesota, United States, 55446-3661
      • Local Institution - 0174
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564-5803
      • Local Institution - 0184
  • Missouri
    • Chesterfield, Missouri, United States, 63005-1248
      • Local Institution - 0024
    • Weldon Spring, Missouri, United States, 63304-9103
      • Local Institution - 0213
  • New Jersey
    • Englewood, New Jersey, United States, 07631-4141
      • Local Institution - 0180
  • New York
    • Brooklyn, New York, United States, 11203-2054
      • Local Institution - 0084
    • New York, New York, United States, 10016-6821
      • Local Institution - 0187
    • New York, New York, United States, 10016-9401
      • Local Institution - 0059
    • New York, New York, United States, 10016-9401
      • NYU Langone Health -Inflammatory Bowel Disease Center
    • New York, New York, United States, 10021
      • Local Institution - 0176
    • Utica, New York, United States, 13502
      • Local Institution - 0170
  • North Carolina
    • Greenville, North Carolina, United States, 27834-3761
      • Carolina Digestive Diseases
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3019
      • Local Institution - 0005
    • Cincinnati, Ohio, United States, 45229-3019
      • University of Cincinnati Physicians Company
    • Columbus, Ohio, United States, 43235-5424
      • Local Institution - 0188
    • Mentor, Ohio, United States, 44060-6521
      • Local Institution - 0061
  • Rhode Island
    • Providence, Rhode Island, United States, 02905-3105
      • Local Institution - 0060
  • Tennessee
    • Cordova, Tennessee, United States, 38018-6362
      • Local Institution - 0177
    • Nashville, Tennessee, United States, 37211-4981
      • Local Institution - 0168
  • Texas
    • Bellaire, Texas, United States, 77401
      • Local Institution - 0038
    • Bellaire, Texas, United States, 77401
      • Novel Research LLC
    • Dallas, Texas, United States, 75246
      • Local Institution - 0138
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77024-2469
      • Local Institution - 0036
    • Houston, Texas, United States, 77024-2469
      • Local Institution - 0163
    • Houston, Texas, United States, 77024
      • Ace Clinical Research Group: Digestive Health Associates
    • Houston, Texas, United States, 77030
      • Local Institution - 0052
    • Katy, Texas, United States, 77494
      • Local Institution - 0129
    • Lubbock, Texas, United States, 79410-2014
      • Local Institution - 0161
    • Mansfield, Texas, United States, 76063-6083
      • GI Alliance: Mansfield - TDDC
    • Mansfield, Texas, United States, 76063-6083
      • Local Institution - 0039
    • San Antonio, Texas, United States, 78229-3270
      • Local Institution - 0201
    • San Antonio, Texas, United States, 78229-4463
      • Local Institution - 0043
    • San Antonio, Texas, United States, 78229-4463
      • San Antonio Gastroenterology
    • San Marcos, Texas, United States, 78666-7502
      • Local Institution - 0166
    • Tyler, Texas, United States, 75701-4464
      • Local Institution - 0046
    • Tyler, Texas, United States, 75701-4464
      • Tyler Research Institute, LLC
    • Webster, Texas, United States, 77598
      • Local Institution - 0091
  • Utah
    • Ogden, Utah, United States, 84403-3294
      • Local Institution - 0193
    • Salt Lake City, Utah, United States, 84132-0001
      • Local Institution - 0169
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Local Institution - 0197
  • Washington
    • Seattle, Washington, United States, 98104-1356
      • Local Institution - 0130
    • Tacoma, Washington, United States, 98405-2318
      • Local Institution - 0189
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Madison, Wisconsin, United States, 53705-1311
      • Local Institution - 0017

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - Advanced therapy-naive	Drug: Ozanimod; Specified dose on specified days; Other Names: BMS-986374; Zeposia®; RPC-1063
Experimental: Cohort 2 - Advanced therapy-exposed	Drug: Ozanimod; Specified dose on specified days; Other Names: BMS-986374; Zeposia®; RPC-1063

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A Treatment Emergent Adverse Event (TEAE) is an AE that meets any of the following: Starts after the first dose of the study treatment (or within 84 days after stopping it) and was not present before; or; Was already present before treatment but gets worse after the first dose (or within 84 days after stopping it); or; Has missing onset and end dates, making it unclear whether it occurred outside the treatment-emergent period. Participants meeting any of these conditions are counted as having at least one TEAE.	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)	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient hospitalization or causes prolongation of existing hospitalization, or results in persistent/significant disability/incapacity. Treatment Emergent Serious Adverse Event (TE SAE) is a SAE that meets any of the following: Starts after the first dose of the study treatment (or within 84 days after stopping it) and was not present before; or; Was already present before treatment but gets worse after the first dose (or within 84 days after stopping it); or; Has missing onset and end dates, making it unclear whether it occurred outside the treatment-emergent period. Participants meeting any of these conditions are counted as having at least one TESAE.	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	This endpoint reports the number of participants who experienced Adverse Events of Interest (AEIs) during the study. AEIs include bradycardia, heart conduction abnormalities (second-degree and higher atrioventricular block), macular edema, malignancy, serious or opportunistic infection, pulmonary effects, hepatic effects, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy (PML), and events associated with orthostatic hypotension (e.g., dizziness, lightheadedness, syncope, seizure). The Sponsor may request additional information for nonserious AEIs. A Treatment Emergent AEI is an AEI that starts after the first dose (or within 84 days after stopping), worsens relative to baseline in this period (or within 84 days after stopping), or has missing dates making the timing unclear. Participants meeting any of these conditions are counted as having at least one AEI.	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	This endpoint measures the number of participants who experienced Treatment Emergent Adverse Events (TEAEs) that resulted in discontinuation of study treatment. An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A TEAE is an AE that: starts after the first dose (or within 84 days after stopping) and was not present before; or was preexisting but worsens after the first dose (or within 84 days after stopping); or has missing dates that prevent determining whether it occurred outside the treatment emergent period.	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	Number of participants experiencing clinically significant abnormalities in laboratory testing including hematology, chemistry and urinalysis.	From first dose of study medication through end of study (Up to approximately 728 days)
Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104	Clinical remission is defined as a Partial Mayo Score of ≤ 2.5. The Partial Mayo Score is a tool that helps doctors measure how active ulcerative colitis is without using endoscopy. It combines three components: Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools); Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding); Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. A score of 2.5 or below suggests the disease is in remission.	At week 52 and week 104
Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104	Corticosteroid-free Clinical Remission (Partial Mayo Score) is defined as: Meeting the criteria for clinical remission by Partial Mayo Score <=2.5, and; No use of oral systemic corticosteroids in the prior 90 days. The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components: Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools); Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding); Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity	At week 52 and week 104
Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104	Clinical Response by Partial Mayo Score is defined as: Decrease in partial Mayo score ⩾ 2 points and ⩾ 30% from baseline, and; Decrease in rectal bleeding subscore > 1 point or absolute rectal bleeding score < 1 This represents a marked improvement in disease activity. The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components: Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools); Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding); Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity.	At week 52 and week 104
Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 1 at Week 12	Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria: Stool Frequency (SF) subscore ≤ 1, with at least a 1-point decrease from baseline; Rectal Bleeding (RB) subscore = 0; Endoscopic Subscore (ES) ≤ 1 The Modified Mayo Score is the sum of the following components (Range: 0-9): SF subscore: range 0-3 (higher score = more frequent stools); RB subscore: range 0-3 (higher score = more bleeding); ES: range 0-3 (higher score = more severe inflammation seen during endoscopy) The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity.	At week 12
Percent of Participants Achieving Endoscopic Response for Cohort 1 at Week 12	Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Score (ES). Mayo Endoscopic Score: range 0-3; Higher ES scores = more severe inflammation and worse mucosal appearance; Lower ES scores = less inflammation and better mucosal healing	At week 12
Percent of Participants Achieving Endoscopic Improvement for Cohort 1 at Week 12	Endoscopic Improvement is defined as: • Mayo Endoscopic Score (ES) ≤ 1 Mayo Endoscopic Score (ES): range 0-3; Higher ES scores = more severe inflammation and worse mucosal appearance; Lower ES scores = less inflammation and better mucosal healing	At week 12
Percent of Participants Achieving Histological Improvement for Cohort 1 at Week 12	Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.; Each domain is graded on a scale, and the total score ranges from 0 to 5.4, with higher scores indicating more severe histologic disease activity.; Higher Geboes scores = more severe microscopic inflammation; Lower Geboes scores = less inflammation and better healing	At week 12
Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 12 for Cohort 1	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms (10 items); Systemic symptoms (5 items); Emotional function (12 items); Social function (5 items) Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL.	At baseline and week 12
Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 12] for Cohort 1	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms: 10 items; Systemic symptoms: 5 items; Emotional function: 12 items; Social function: 5 items Scoring: Each question ranges from 1 ("worst") to 7 ("best").; Total score: 32-224, with higher scores indicating better quality of life (QOL). A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL).	At baseline and week 12
Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 1 at Week 12	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms: 10 items; Systemic symptoms: 5 items; Emotional function: 12 items; Social function: 5 items Scoring: Each question ranges from 1 ("worst") to 7 ("best").; Total score: 32-224, with higher scores indicating better quality of life (QOL). A total score of ≥170 points reflects IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL).	At week 12
Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 2 at Week 26	Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria: Stool Frequency (SF) subscore ≤ 1, with at least a 1-point decrease from baseline; Rectal Bleeding (RB) subscore = 0; Endoscopic Subscore (ES) ≤ 1 The Modified Mayo Score is the sum of the following components (Range: 0-9): SF subscore: range 0-3 (higher score = more frequent stools); RB subscore: range 0-3 (higher score = more bleeding); ES: range 0-3 (higher score = more severe inflammation seen during endoscopy) The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity.	At week 26
Percent of Participants Achieving Endoscopic Response for Cohort 2 at Week 26	Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Sub score (ES). This represents the percentage of treated participants who achieved a decrease from baseline of at least 1 point in the Mayo ES, indicating improvement in mucosal appearance during endoscopy. Mayo Endoscopic Subscore (ES): range 0-3; Higher ES scores = more severe inflammation and worse mucosal appearance; Lower ES scores = less inflammation and better mucosal healing	At week 26
Percent of Participants Achieving Endoscopic Improvement for Cohort 2 at Week 26	Endoscopic Improvement is defined as: • Mayo Endoscopic Subscore (ES) ≤ 1 This represents the percentage of treated participants with Mayo ES ≤ 1, indicating mild or no inflammation. Mayo Endoscopic Subscore (ES): range 0-3; Higher ES scores = more severe inflammation and worse mucosal appearance; Lower ES scores = less inflammation and better mucosal healing	At week 26
Percent of Participants Achieving Endoscopic Remission for Cohort 2 at Week 26	Endoscopic Remission is defined as: • Mayo Endoscopic Sub score (ES) = 0 This represents the percentage of treated participants with Mayo ES = 0, indicating complete mucosal healing. Mayo Endoscopic Sub score (ES): range 0-3; Higher ES scores = more severe inflammation and worse mucosal appearance; Lower ES scores = less inflammation and better mucosal healing	At week 26
Percent of Participants Achieving Histological Improvement for Cohort 2 at Week 26	Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.; Each domain is graded on a scale, and the total score ranges from 0 to 5.4, with higher scores indicating more severe histologic disease activity.; Higher Geboes scores = more severe microscopic inflammation; Lower Geboes scores = less inflammation and better healing	At week 26
Percent of Participants Achieving Histological Remission for Cohort 2 at Week 26	Histological Remission is defined as: • Achieving a Geboes score < 2 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.; Each domain is graded on a scale, and the total score ranges from 0 to 5.4, with higher scores indicating more severe histologic disease activity.; Higher Geboes scores = more severe microscopic inflammation; Lower Geboes scores = minimal or no inflammation and better healing	At week 26
Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 26 for Cohort 2	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms (10 items); Systemic symptoms (5 items); Emotional function (12 items); Social function (5 items) Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL.	At baseline and week 26
Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 26] for Cohort 2	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms: 10 items; Systemic symptoms: 5 items; Emotional function: 12 items; Social function: 5 items Scoring: Each question ranges from 1 ("worst") to 7 ("best").; Total score: 32-224, with higher scores indicating better quality of life (QOL). A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL).	At baseline and week 26
Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 2 at Week 26	IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions: Bowel symptoms: 10 items; Systemic symptoms: 5 items; Emotional function: 12 items; Social function: 5 items Scoring: Each question ranges from 1 ("worst") to 7 ("best").; Total score: 32-224, with higher scores indicating better quality of life (QOL). A total score of ≥170 points reflect IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL).	At week 26
Percent of Participants Achieving Corticosteroid-free Clinical Remission by Modified Mayo Score for Cohort 2 at Week 26	Corticosteroid-free Clinical Remission (modified mayo score) is defined as: Meeting the criteria for clinical remission by Modified Mayo Score [Stool Frequency (SF) subscore ≤ 1, with ≥ 1 point decrease from baseline and; Rectal Bleeding (RB) subscore = 0 and; Endoscopic Subscore (ES) ≤ 1], and; No oral systemic steroid use in the prior 90 days. The Modified Mayo Score is the sum of the following components (Range: 0-9): Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools); Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding); Endoscopic Subscore (ES): range 0-3 (higher score = more severe inflammation seen during endoscopy) The total score ranges from 0 to 9, with: Lower scores = less disease activity and better clinical condition; Higher scores = more severe disease activity	At week 26
Percent of Participants Achieving Histo-endoscopic Mucosal Improvement (HEMI) for Cohort 2 at Week 26	Histo-endoscopic Mucosal Improvement (HEMI) is defined as: Mayo Endoscopic Subscore (ES) ≤ 1, and; Geboes score < 3.1 Mayo Endoscopic Subscore (ES): range 0-3; Higher ES scores = more severe visible inflammation and worse mucosal appearance; Lower ES scores = less visible inflammation and better mucosal healing Geboes Score: Each domain is graded on a scale, and the total score ranges from 0 to 5.4, with higher scores indicating more severe histologic disease activity; Higher Geboes scores = more severe microscopic inflammation; Lower Geboes scores = less microscopic inflammation and better tissue healing Meeting both criteria (ES ≤ 1 and Geboes < 3.1) shows improvement in both endoscopic appearance and microscopic tissue health.	At week 26

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Ozanimod; Inflammatory bowel disease; RPC-1063; Zeposia®
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; ozanimod
• Other Study ID Numbers: IM047-029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No