A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Observational · No treatment assigned · 1 site · Bristol-Myers Squibb
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 19 and older
- Any sex
Some of the main requirements, copied from the record:
- Adult participants 19 years of age or older
- Participants who will receive ozanimod according to the approved label after enrollment
- Participants who sign the informed consent form voluntarily
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 3000 participants are expected to take part.
- Start date: 2024-04-19.
- Main results expected around 2028-04-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in South Korea.
Main thing being measured
- Adverse events (Up to 52 weeks)
In the researchers’ words
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Bristol-Myers Squibb |
| Enrollment | 3000 (estimated) |
| Start date | 2024-04-19 |
| Primary completion (est.) | 2028-04-01 |
| First posted | 2023-10-10 |
| Last updated | 2024-08-22 |
| Official title | Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea |
| ClinicalTrials.gov ID | NCT06073873 |
Interventions
- Ozanimod (Drug)
According to local product label
Full eligibility criteria (from the record)
Inclusion Criteria: * Adult participants 19 years of age or older * Participants who will receive ozanimod according to the approved label after enrollment * Participants who sign the informed consent form voluntarily Exclusion Criteria: * Participants who are prescribed ozanimod for therapeutic indications not approved in Korea * Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol-Myers Squibb YH | Seoul | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.