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Active Not Recruiting
NCT06964113
A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice
Conditions: Ulcerative Colitis
Sex: All
Ages: 19 Years – 64 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 94
Sponsor: Eisai Korea Inc.
Location: Eisai Site #13 Busan
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 with the study protocol procedures
Exclusion Criteria:
1. Participants with hypersensitivity to the active substance or to any of the excipients listed in the approved label of filgotinib
2. Participants with active infections, including serious infections (example \[e.g.\], sepsis) or local infections
3. Participants with active tuberculosis (TB). For participants with latent tuberculosis, domestic standard anti-tuberculosis therapy must be initiated at least 3 weeks prior to the first administration of the study drug (Visit 2, Day 1).
4. Participants with severe hepatic impairment (Child-Pugh C)
5. Participants with moderate or greater renal impairment (Creatinine Clearance \[CrCl\] less than (\
Source: ClinicalTrials.gov (NCT06964113). StuddyBuddy aggregates publicly available trial information.