The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 6, 2022
First Posted Date  ICMJE May 11, 2022
Last Update Posted Date May 7, 2024
Actual Study Start Date  ICMJE December 16, 2022
Estimated Primary Completion Date November 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2022)		 Clinical response as measured by modified Mayo score at Week 12 [ Time Frame: Up to approximately 26 weeks ]
Cohort 1 and 2
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2022)		 Clinical response as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
Cohort 1 and 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2022)
  • Clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic response [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve histological improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • 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
  • 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
  • Proportion of participants with IBDQ remission with total score of ≥ 170 points [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants who achieve histological remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Corticosteroid-free clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants with histo-endoscopic mucosal improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2
  • Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2
  • Proportion of participants with AEs of interest (AEI) [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2
  • Proportion of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2
  • Proportion of participants with clinical laboratory abnormalities [ Time Frame: Up to approximately 2 years ]
    Cohort 1 and 2
  • Clinical remission by partial Mayo score [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2
  • Corticosteroid-free clinical remission by partial Mayo [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2
  • Clinical response by partial Mayo score [ Time Frame: Up to approximately 104 weeks ]
    Cohort 1 and 2
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2022)
  • Clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic response [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve histological improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • 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
  • 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
  • Proportion of participants with IBDQ remission with total score of ≥ 170 points [ Time Frame: Up to approximately 26 weeks ]
    Cohort 1 and 2
  • Proportion of participants who achieve endoscopic remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants who achieve histological remission [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Corticosteroid-free clinical remission as measured by modified Mayo score [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants with histo-endoscopic mucosal improvement [ Time Frame: Up to approximately 26 weeks ]
    Cohort 2 only
  • Proportion of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
    Cohort 1 and 2
  • Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 3 years ]
    Cohort 1 and 2
  • Proportion of participants with AEs of interest (AEI) [ Time Frame: Up to approximately 3 years ]
    Cohort 1 and 2
  • Proportion of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 3 years ]
    Cohort 1 and 2
  • Proportion of participants with clinical laboratory abnormalities [ Time Frame: Up to approximately 3 years ]
    Cohort 1 and 2
  • Clinical remission by partial Mayo score [ Time Frame: Up to approximately 156 weeks ]
    Cohort 1 and 2
  • Corticosteroid-free clinical remission by partial Mayo [ Time Frame: Up to approximately 156 weeks ]
    Cohort 1 and 2
  • Clinical response by partial Mayo score [ Time Frame: Up to approximately 156 weeks ]
    Cohort 1 and 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE Drug: Ozanimod
Specified dose on specified days
Other Names:
  • Zeposia®
  • RPC-1063
  • BMS-986374
Study Arms  ICMJE
  • Experimental: Cohort 1 - Advanced therapy-naive
    Intervention: Drug: Ozanimod
  • Experimental: Cohort 2 - Advanced therapy-exposed
    Intervention: Drug: Ozanimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2022)		 415
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2022)		 580
Estimated Study Completion Date  ICMJE April 28, 2027
Estimated Primary Completion Date November 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries Puerto Rico,   Spain
 
Administrative Information
NCT Number  ICMJE NCT05369832
Other Study ID Numbers  ICMJE IM047-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP