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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice (NCT06964113) is a Phase 4 interventional studying Ulcerative Colitis, sponsored by Eisai Korea Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 94 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Filgotinib Maleate

Administered as oral tablets.

Locations (19)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06964113), the sponsor (Eisai Korea Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06964113 clinical trial studying?

The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06964113?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06964113?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06964113. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06964113. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.