A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

NCT06964113 | Recruiting Phase 4

• 1 other identifier: GS6034-M082-402
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Jyseleca; Filgotinib maleate

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Remission at Week 10 or 22

  At Week 10 or 22

Secondary Outcomes (15)

• Percentage of Participants Achieving Clinical Remission at Weeks 10, 22 and 58

  At Weeks 10, 22 and 58

• Percentage of Clinical Responders at Week 10 and 22

  At Week 10 and 22

• Percentage of Participants Achieving Sustained Clinical Remission at Week 58

  At Week 58

• Percentage of Participants Achieving Mayo Clinic Score (MCS) Remission at Weeks 10, 22, and 58

  At Weeks 10, 22, and 58

• Percentage of Participants Achieving Endoscopic Subscore of 0 at Weeks 10, 22, and 58

  At Weeks 10, 22, and 58

Study Arms (1)

Filgotinib Maleate 200 milligram per day (mg/day)

EXPERIMENTAL

Drug: Filgotinib Maleate

Interventions

Filgotinib Maleate DRUG

Administered as oral tablets.

Also known as: Jyseleca

Filgotinib Maleate 200 milligram per day (mg/day)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants with hypersensitivity to the active substance or to any of the excipients listed in the approved label of filgotinib
• Participants with active infections, including serious infections (example \[e.g.\], sepsis) or local infections
• 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).
• Participants with severe hepatic impairment (Child-Pugh C)
• Participants with moderate or greater renal impairment (Creatinine Clearance \[CrCl\] less than (\<) 60 milliliter per minute \[mL/min\])
• Participants who meet any of the following laboratory values:
• Absolute neutrophil count (ANC) less than (\<) 1\*10\^9 cells per liter (/L)
• Absolute lymphocyte count (ALC) \<0.5\*10\^9 cells/L
• Hemoglobin level \<8 grams per deciliter (g/dL)
• Hemoglobin level \<8 g/dL
• Female participants who are pregnant or breastfeeding at Visit 1. Even if a pregnancy test result at Visit 1 was negative, a separate evaluation is required at Visit 2 if the first dose of the study drug was administered more than 72 hours after the pregnancy test.
• Female participants of childbearing potential who do not agree to use one of the following highly effective methods of contraception from 4 weeks prior to Visit 1 until 4 weeks after the last dose of study drug:
• Complete abstinence (if this is the preferred and usual lifestyle of the participants)
• Intrauterine device or hormone-containing intrauterine system (IUS)
• Contraceptive implant

Sponsors & Collaborators

• Gilead Sciences: collaborator
• Eisai Korea Inc.: lead

Study Sites (19)

Eisai Site #13

Busan, South Korea

RECRUITING

Eisai Site #15

Busan, South Korea

RECRUITING

Eisai Site #8

Busan, South Korea

RECRUITING

Eisai Site #6

Daegu, South Korea

RECRUITING

Eisai Site #2

Daejeon, South Korea

RECRUITING

Eisai Site #16

Gyeonggi-do, South Korea

RECRUITING

Eisai Site #4

Gyeonggi-do, South Korea

RECRUITING

Eisai Site #11

Gyeongnam, South Korea

RECRUITING

Eisai Site #18

Jungnam, South Korea

RECRUITING

Eisai Site #7

Jungnam, South Korea

RECRUITING

Eisai Site #10

Seoul, South Korea

RECRUITING

Eisai Site #12

Seoul, South Korea

RECRUITING

Eisai Site #14

Seoul, South Korea

RECRUITING

Eisai Site #17

Seoul, South Korea

RECRUITING

Eisai Site #19

Seoul, South Korea

RECRUITING

Eisai Site #1

Seoul, South Korea

RECRUITING

Eisai Site #3

Seoul, South Korea

RECRUITING

Eisai Site #5

Seoul, South Korea

RECRUITING

Eisai Site #9

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Medical department Serena SoYoun Kwon

CONTACT

+82-2-3451-5533; s-kwon@eisaikorea.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 9, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (19)