Actively Recruiting
A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice
Led by Eisai Korea Inc. · Updated on 2026-04-30
94
Participants Needed
19
Research Sites
128 weeks
Total Duration
On this page
Sponsors
E
Eisai Korea Inc.
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
CONDITIONS
Official Title
A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 64 years at the time of consent
- Diagnosed with moderately to severely active ulcerative colitis with a Mayo Clinic Score between 6 and 12, including an endoscopy sub-score of 2 or higher
- Inadequate response, loss of response, or intolerance to conventional therapy or biologic agents
- Able and willing to follow study procedures and provide reliable information
You will not qualify if you...
- Allergy or hypersensitivity to filgotinib or any ingredients in its approved label
- Active infections, including serious or local infections
- Active tuberculosis; if latent TB, must have started anti-TB treatment at least 3 weeks before study drug
- Severe liver impairment (Child-Pugh C)
- Moderate or worse kidney impairment (creatinine clearance below 60 mL/min)
- Low blood counts: absolute neutrophil count less than 1 x 10^9 cells/L, absolute lymphocyte count less than 0.5 x 10^9 cells/L, or hemoglobin less than 8 g/dL
- Pregnant or breastfeeding women at the start of the study
- Women of childbearing potential not agreeing to use effective contraception during and 4 weeks after treatment
- Hereditary intolerance to galactose, total lactase deficiency, or glucose-galactose malabsorption
- Previous treatment with a Janus kinase (JAK) inhibitor
- Participation in another clinical trial or use of investigational products within 4 weeks before screening
- Any condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Eisai Site #13
Busan, South Korea
Actively Recruiting
2
Eisai Site #15
Busan, South Korea
Actively Recruiting
3
Eisai Site #8
Busan, South Korea
Actively Recruiting
4
Eisai Site #6
Daegu, South Korea
Actively Recruiting
5
Eisai Site #2
Daejeon, South Korea
Actively Recruiting
6
Eisai Site #16
Gyeonggi-do, South Korea
Actively Recruiting
7
Eisai Site #4
Gyeonggi-do, South Korea
Actively Recruiting
8
Eisai Site #11
Gyeongnam, South Korea
Actively Recruiting
9
Eisai Site #18
Jungnam, South Korea
Actively Recruiting
10
Eisai Site #7
Jungnam, South Korea
Actively Recruiting
11
Eisai Site #10
Seoul, South Korea
Actively Recruiting
12
Eisai Site #12
Seoul, South Korea
Actively Recruiting
13
Eisai Site #14
Seoul, South Korea
Actively Recruiting
14
Eisai Site #17
Seoul, South Korea
Actively Recruiting
15
Eisai Site #19
Seoul, South Korea
Actively Recruiting
16
Eisai Site #1
Seoul, South Korea
Actively Recruiting
17
Eisai Site #3
Seoul, South Korea
Actively Recruiting
18
Eisai Site #5
Seoul, South Korea
Actively Recruiting
19
Eisai Site #9
Seoul, South Korea
Actively Recruiting
Research Team
M
Medical department Serena SoYoun Kwon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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