NCT06964113 A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice
| NCT ID | NCT06964113 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Eisai Korea Inc. |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2025-06-11 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 94 participants in total. It began in 2025-06-11 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
Eligibility Criteria
Inclusion Criteria: 1. Adult participants aged 19 to 64 years at the time of written consent 2. Participants must meet both of the following conditions: i) Diagnosed with moderately to severely active ulcerative colitis as determined by the Mayo Clinic Score with endoscopy occurring during screening; total score must be between 6 and 12, inclusive and endoscopy sub-score greater than or equal to (\>=) 2 (However, if there are results of an endoscopy performed within two (2) months of the screening visit, and if NHI evaluation can be performed using the stored specimens obtained from that endoscopy, it can replace screening endoscopy.) ii) Have had an inadequate response to, lost response to, or were intolerant to either conventional therapy (corticosteroids, immunosuppressants, etc.) or a biologic agent based on the investigator's judgement at the screening visit. 3. Participant who is considered reliable by the investigator regarding provision of information, and is willing to comply
Frequently Asked Questions
Who can join the NCT06964113 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 64 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06964113 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06964113 currently recruiting?
Yes, NCT06964113 is actively recruiting participants. Visit ClinicalTrials.gov or contact Eisai Korea Inc. to inquire about joining.
Where is the NCT06964113 trial being conducted?
This trial is being conducted at Busan, South Korea, Busan, South Korea, Busan, South Korea, Daegu, South Korea and 1 additional location.
Who is sponsoring the NCT06964113 clinical trial?
NCT06964113 is sponsored by Eisai Korea Inc.. The trial plans to enroll 94 participants.
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