A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis (COLIBRI)

Ulcerative Colitis in Subjects of Clinical Routine: A Four Year, Multicenter, Prospective, Non-Interventional Study to Evaluate Utilization, Effectiveness, and Quality of Life With Ozanimod

The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10825
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Participants with moderate-to-severe ulcerative colitis (UC) who initiate treatment with commercially available Ozanimod (Zeposia®) according to summary of product characteristics (SmPC) will be observed in a real-world setting in Germany over a 4-year period.

Description

Inclusion Criteria:

• Only Ozanimod (Zeposia®) naïve participants can be included into this prospective study
• Participants are suitable for therapy with Ozanimod (Zeposia®) according to the physician's recommendation (made before enrollment and independently of this Non-Interventional Study (NIS))
• Treatment with Ozanimod (Zeposia®) must be in-label and follow the approved Summary of Product Characteristics (SmPC)
• Participants must have confirmed diagnosis of moderate-to-severe Ulcerative Colitis

Exclusion Criteria:

• Participants that have previously been treated with Ozanimod (Zeposia®)
• Participants with mild Ulcerative Colitis (UC)
• Participants with a stoma
• Participants participating in other clinical trials
• Participants with a planned surgical intervention and hospitalization due to UC
• Participants with any contraindications specified in the current version of the SmPC

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1	Drug: Ozanimod; Specified Dose on Specified Days; Other Names: Zeposia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0	At week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Persistence of therapy during the study course measured by the number of participants who are on continuous treatment	Up to Week 52
Number of participants with Clinical Response	At Week 10 and Week 52
Number of participants with Clinical Remission	Up to Week 52
Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10	Up to Week 52
Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)	Up to 1 Year
Patient's satisfaction with therapy measured by the TSQM-9	Up to 1 Year
Time to discontinuation of treatment	Up to 1 Year
Change from baseline in Patient-Reported Outcomes (PROs) with regards to fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Up to 1 Year
Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)	Up to 1 Year
Number of participants with Adverse Events (AEs)	Up to 1 Year
Number of participants with Corticosteroid (CS)-Free clinical response	Up to 1 Year
Number of participants with CS-Free clinical remission	Up to 1 Year

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
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Ozanimod; Inflammatory Bowel Diseases; Colitis, Ulcerative; Zeposia
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Ozanimod
• Other Study ID Numbers: IM047-027

Drug and device information, study documents

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