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

NCT05382715 | Terminated FDA Drug

• 1 other identifier: IM047-027
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Colitis, Ulcerative

Keywords

Colitis, Ulcerative; Zeposia; Ozanimod; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0

  At week 10

Secondary Outcomes (12)

• 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

Study Arms (1)

Cohort 1

Drug: Ozanimod

Interventions

Ozanimod DRUG

Specified Dose on Specified Days

Also known as: Zeposia®

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Berlin, 10825, Germany

Location

Related Links

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

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: May 30, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

DE (1)