A Multi-center, Open-Label, Single-Arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib 200 mg in Korean Patients With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 64
Healthy Volunteers: f
View:

• Adult participants aged 19 to 64 years at the time of written consent

• 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.

• Participant who is considered reliable by the investigator regarding provision of information, and is willing to comply with the study protocol procedures

Locations
Other Locations
Republic of Korea
Eisai Site #13
RECRUITING
Busan
Eisai Site #15
RECRUITING
Busan
Eisai Site #8
RECRUITING
Busan
Eisai Site #6
RECRUITING
Daegu
Eisai Site #2
RECRUITING
Daejeon
Eisai Site #7
RECRUITING
Jungnam
Eisai Site #1
RECRUITING
Seoul
Eisai Site #10
RECRUITING
Seoul
Eisai Site #12
RECRUITING
Seoul
Eisai Site #14
RECRUITING
Seoul
Eisai Site #3
RECRUITING
Seoul
Eisai Site #5
RECRUITING
Seoul
Eisai Site #9
RECRUITING
Seoul
Eisai Site #4
RECRUITING
Suwon
Eisai Site #11
RECRUITING
Yangsan
Contact Information
Primary
Medical department Serena SoYoun Kwon
s-kwon@eisaikorea.com
+82-2-3451-5533
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 94
Treatments
Experimental: Filgotinib Maleate 200 milligram per day (mg/day)
Sponsors
Collaborators: Gilead Sciences
Leads: Eisai Korea Inc.

This content was sourced from clinicaltrials.gov

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