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Filgotinib 200 mg for Korean adults with moderate to severe ulcerative colitis during routine care

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

Phase 4 Interventional Eisai Inc. · NCT06964113

This trial will try filgotinib 200 mg to see if it can bring Korean adults with moderate to severe ulcerative colitis into clinical remission by Week 10 or Week 22.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment94 (estimated)
Ages19 Years to 64 Years
SexAll
SponsorEisai Inc. Industry-sponsored
Drugs / interventionsfilgotinib
Locations19 sites (Busan and 18 other locations)
Trial IDNCT06964113 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study will give filgotinib maleate 200 mg to adults aged 19–64 with moderately to severely active ulcerative colitis defined by a Mayo Clinic Score of 6–12 and endoscopy subscore ≥2. Participants must have had an inadequate response to, loss of response to, or intolerance of conventional or biologic therapies. Clinical remission will be measured at Week 10 or Week 22 using standard clinical and endoscopic criteria, and participants will be followed under routine clinical-practice conditions at participating sites. The study is sponsored by Eisai Korea with collaboration from Gilead Sciences and conducted at multiple Eisai sites in Busan, Korea.

Who should consider this trial

Good fit: Adults 19–64 in Korea with moderately to severely active ulcerative colitis (Mayo score 6–12 with endoscopy subscore ≥2) who have not responded to or are intolerant of conventional or biologic treatments are ideal candidates.

Not a fit: People with mild ulcerative colitis, those outside the 19–64 age range, or those whose disease is well controlled on current therapies are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, filgotinib could provide another effective oral option to help Korean adults with moderate to severe ulcerative colitis reach and maintain remission.

How similar studies have performed: Previous randomized trials and regulatory approvals have shown filgotinib can induce remission in ulcerative colitis, so this Phase 4 work extends those findings into routine clinical practice in Korea.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Busan and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisJyselecaFilgotinib maleate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.