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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05369832
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Ozanimod Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 415 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 16, 2022
Estimated Primary Completion Date : November 29, 2024
Estimated Study Completion Date : April 28, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 - Advanced therapy-naive Drug: Ozanimod
Specified dose on specified days
Other Names:
  • Zeposia®
  • RPC-1063
  • BMS-986374
Experimental: Cohort 2 - Advanced therapy-exposed Drug: Ozanimod
Specified dose on specified days
Other Names:
  • Zeposia®
  • RPC-1063
  • BMS-986374


Outcome Measures
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Primary Outcome Measures :
  1. Clinical response as measured by modified Mayo score at Week 12 [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2


Secondary Outcome Measures :
  1. Clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  2. Proportion of participants who achieve endoscopic response [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  3. Proportion of participants who achieve endoscopic improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  4. Proportion of participants who achieve histological improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  5. Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  6. Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  7. Proportion of participants with IBDQ remission with total score of ≥ 170 points [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2

  8. Proportion of participants who achieve endoscopic remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only

  9. Proportion of participants who achieve histological remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only

  10. Corticosteroid-free clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only

  11. Proportion of participants with histo-endoscopic mucosal improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only

  12. Proportion of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2

  13. Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2

  14. Proportion of participants with AEs of interest (AEI) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2

  15. Proportion of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2

  16. Proportion of participants with clinical laboratory abnormalities [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2

  17. Clinical remission by partial Mayo score [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2

  18. Corticosteroid-free clinical remission by partial Mayo [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2

  19. Clinical response by partial Mayo score [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05369832


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05369832    
Other Study ID Numbers: IM047-029
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Ulcerative Colitis
Ozanimod
RPC-1063
Zeposia®
Inflammatory bowel disease
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Ozanimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs