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

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

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Filgotinib Maleate

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Medical department Serena SoYoun Kwon; Phone Number: +82-2-3451-5533; Email: s-kwon@eisaikorea.com

Study Locations

• South Korea
  • Busan, South Korea
    • Recruiting
    • Eisai site #13
  • Busan, South Korea
    • Recruiting
    • Eisai site #15
  • Busan, South Korea
    • Recruiting
    • Eisai Site #8
  • Daegu, South Korea
    • Recruiting
    • Eisai Site #6
  • Daejeon, South Korea
    • Recruiting
    • Eisai Site #2
  • Gyeonggi-do, South Korea
    • Recruiting
    • Eisai Site #16
  • Gyeonggi-do, South Korea
    • Recruiting
    • Eisai Site #4
  • Gyeongnam, South Korea
    • Recruiting
    • Eisai site #11
  • Jungnam, South Korea
    • Recruiting
    • Eisai Site #7
  • Jungnam, South Korea
    • Recruiting
    • Eisai Site #18
  • Seoul, 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 #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
    • Eisai Site #17
  • Seoul, South Korea
    • Recruiting
    • Eisai Site #19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 (<) 60 milliliter per minute [mL/min])
6. Participants who meet any of the following laboratory values:

7. 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
8. 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.

9. 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
   • Oral contraceptives (participants must be on the same oral contraceptive at a stable dose for at least 4 weeks prior to the administration of the study drug, during the study and for 4 weeks after discontinuation of the study drug)
   • Partner has had a vasectomy and is confirmed to be azoospermia If a highly effective method of contraception is not appropriate or acceptable for the participants, the participants must agree to use a medically acceptable method of contraception, that is (i.e.), double barrier method of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide.

   Note: All women will be considered to be of childbearing potential unless they are postmenopausal (at least 12 consecutive months of amenorrhea with no other known or suspected cause) or surgically sterile (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all surgically performed, at least 1 month prior to the administration of the study drug).

10. Participants with hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
11. Participants with a history of prior treatment with Janus kinase (JAK) inhibitor
12. Participants currently participating in other clinical study or participants who used other investigational product/medical device within 4 weeks of the screening visit
13. Participants deemed inappropriate to participate in this study at the investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Filgotinib Maleate 200 milligram per day (mg/day)	Drug: Filgotinib Maleate; Administered as oral tablets.; Other Names: Jyseleca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 10 or 22	At Week 10 or 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	MCS remission is defined as a MCS of 2 or less and no single sub-score higher than 1 at each time of evaluation.	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
Percentage of Participants Achieving Nancy Histologic Index (NHI) Histologic Remission at Weeks 10, 22, and 58		At Weeks 10, 22, and 58
Percentage of Participants Achieving MCS Remission (Alternative Definition) at Weeks 10, 22, and 58	MCS remission (alternative definition) is defined as rectal bleeding (RB), stool frequency (SF), and physician's global assessment (PGA) sub-scores of 0 and an endoscopic sub-score of 0 or 1 (overall MCS of less than or equal to [<=1]) at each time of evaluation.	At Weeks 10, 22, and 58
Percentage of Participants Achieving 6-month Corticosteroid-free Clinical Remission at Week 58		At Week 58
Number of Participants With Adverse Events (AEs)		Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Laboratory Tests		Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Vital Signs		Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Weight		Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Measurements		Up to 62 weeks
Duration of Filgotinib Exposure		Up to 58 weeks
Percentage of Participants Who Complied to Treatment		Up to 58 weeks

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: May 2, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Jyseleca; Filgotinib maleate
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: GS6034-M082-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No