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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05369832
• Collaborator: (none)
• Enrollment: 580
• Arms: 2
• Anticipated Duration (Months): 56.8

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the safety, efficacy, quality of life, and biomarker response in participants with moderate to severe ulcerative colitis in clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Ozanimod	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 580 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Global, 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
• Anticipated Study Start Date: Aug 3, 2022
• Anticipated Primary Completion Date: Nov 29, 2024
• Anticipated Study Completion Date: Apr 28, 2027

Arms and Interventions

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

Primary Outcome Measures

1. Clinical response as measured by modified Mayo score [Up to approximately 26 weeks]

   Cohort 1 and 2

Secondary Outcome Measures

1. Clinical remission as measured by modified Mayo score [Up to approximately 26 weeks]

   Cohort 1 and 2

2. Proportion of participants who achieve endoscopic response [Up to approximately 26 weeks]

   Cohort 1 and 2

3. Proportion of participants who achieve endoscopic improvement [Up to approximately 26 weeks]

   Cohort 1 and 2

4. Proportion of participants who achieve histological improvement [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 [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 [Up to approximately 26 weeks]

   Cohort 1 and 2

7. Proportion of participants with IBDQ remission with total score of ≥ 170 points [Up to approximately 26 weeks]

   Cohort 1 and 2

8. Proportion of participants who achieve endoscopic remission [Up to approximately 26 weeks]

   Cohort 2 only

9. Proportion of participants who achieve histological remission [Up to approximately 26 weeks]

   Cohort 2 only

10. Corticosteroid-free clinical remission as measured by modified Mayo score [Up to approximately 26 weeks]

    Cohort 2 only

11. Proportion of participants with histo-endoscopic mucosal improvement [Up to approximately 26 weeks]

    Cohort 2 only

12. Proportion of participants with Adverse Events (AEs) [Up to approximately 3 years]

    Cohort 1 and 2

13. Proportion of participants with Serious Adverse Events (SAEs) [Up to approximately 3 years]

    Cohort 1 and 2

14. Proportion of participants with AEs of interest (AEI) [Up to approximately 3 years]

    Cohort 1 and 2

15. Proportion of participants with AEs leading to discontinuation [Up to approximately 3 years]

    Cohort 1 and 2

16. Proportion of participants with clinical laboratory abnormalities [Up to approximately 3 years]

    Cohort 1 and 2

17. Clinical remission by partial Mayo score [Up to approximately 156 weeks]

    Cohort 1 and 2

18. Corticosteroid-free clinical remission by partial Mayo [Up to approximately 156 weeks]

    Cohort 1 and 2

19. Clinical response by partial Mayo score [Up to approximately 156 weeks]

    Cohort 1 and 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 5 through 9, inclusive

• 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

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05369832
• Other Study ID Numbers: IM047-029
• First Posted: May 11, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• 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: Colitis; Colitis, Ulcerative; Ulcer; Ozanimod

Study Results

No Results Posted as of May 11, 2022