RecruitingPhase 4NCT06964113

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

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


Sponsor

Eisai Korea Inc.

Enrollment

94 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how well filgotinib (an oral medication) works in real-world clinical practice for Korean adults with moderate to severe ulcerative colitis — an inflammatory bowel condition that causes chronic colon inflammation. **You may be eligible if...** - You are between 19 and 64 years old - You have been diagnosed with moderately to severely active ulcerative colitis, confirmed by a bowel scope (endoscopy) - Your doctor has independently decided to prescribe filgotinib as part of your standard care **You may NOT be eligible if...** - You are under 19 or over 64 years old - You have Crohn's disease rather than ulcerative colitis - You have active serious infections or certain other health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFilgotinib Maleate

Administered as oral tablets.


Locations(19)

Eisai Site #13

Busan, South Korea

Eisai Site #15

Busan, South Korea

Eisai Site #8

Busan, South Korea

Eisai Site #6

Daegu, South Korea

Eisai Site #2

Daejeon, South Korea

Eisai Site #16

Gyeonggi-do, South Korea

Eisai Site #4

Gyeonggi-do, South Korea

Eisai Site #11

Gyeongnam, South Korea

Eisai Site #18

Jungnam, South Korea

Eisai Site #7

Jungnam, South Korea

Eisai Site #10

Seoul, South Korea

Eisai Site #12

Seoul, South Korea

Eisai Site #14

Seoul, South Korea

Eisai Site #17

Seoul, South Korea

Eisai Site #19

Seoul, South Korea

Eisai Site #1

Seoul, South Korea

Eisai Site #3

Seoul, South Korea

Eisai Site #5

Seoul, South Korea

Eisai Site #9

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06964113


Related Trials