Colitis, UlcerativeCOLIBRINCT05382715
A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis
An observational study of Colitis, Ulcerative, run by Bristol-Myers Squibb at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Ozanimod
- How many people
- 175 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Colitis, Ulcerative
- Being tested
- Ozanimod
- Keywords
- Colitis, Ulcerative, Zeposia, Ozanimod, Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Also called Zeposia®
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Not described Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0
Measured: At week 10
Secondary outcomes (12)
Persistence of therapy during the study course measured by the number of participants who are on continuous treatment
Measured: Up to Week 52
Number of participants with Clinical Response
Measured: At Week 10 and Week 52
Number of participants with Clinical Remission
Measured: Up to Week 52
Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10
Measured: Up to Week 52
Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)
Measured: Up to 1 Year
Patient's satisfaction with therapy measured by the TSQM-9
Measured: Up to 1 Year
Time to discontinuation of treatment
Measured: 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)
Measured: Up to 1 Year
Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)
Measured: Up to 1 Year
Number of participants with Adverse Events (AEs)
Measured: Up to 1 Year
Number of participants with Corticosteroid (CS)-Free clinical response
Measured: Up to 1 Year
Number of participants with CS-Free clinical remission
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start30 May 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382715
- Sponsor's protocol ID
- IM047-027
- Acronym
- COLIBRI
- Status last verified
- Jun 2025
- First submitted
- 16 May 2022
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05382715
- Acronym / sponsor ID
- COLIBRI / IM047-027
- Conditions
- Colitis, Ulcerative
- Keywords
- Colitis, Ulcerative, Zeposia, Ozanimod, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Ozanimod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodAlso: Zeposia®Specified Dose on Specified Days | Drug | Cohort 1 |
Primary outcome
Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0
Time frame: At week 10
12 secondary outcomes
Persistence of therapy during the study course measured by the number of participants who are on continuous treatment
Time frame: Up to Week 52
Number of participants with Clinical Response
Time frame: At Week 10 and Week 52
Number of participants with Clinical Remission
Time frame: Up to Week 52
Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10
Time frame: Up to Week 52
Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)
Time frame: Up to 1 Year
Patient's satisfaction with therapy measured by the TSQM-9
Time frame: Up to 1 Year
Time to discontinuation of treatment
Time frame: 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)
Time frame: Up to 1 Year
Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)
Time frame: Up to 1 Year
Number of participants with Adverse Events (AEs)
Time frame: Up to 1 Year
Number of participants with Corticosteroid (CS)-Free clinical response
Time frame: Up to 1 Year
Number of participants with CS-Free clinical remission
Time frame: Up to 1 Year
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Ulcerative, run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0 (time frame: At week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.