A Phase 4 interventional study of Filgotinib Maleate in Ulcerative Colitis, sponsored by Eisai Korea Inc.. Active, not recruiting at 19 sites in South Korea. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Phase 4, Interventional, and Treatment
Among 137 studies in Colitis, Ulcerative with a site in Korea, Republic of — 24 open to participants now, 44 under way, 21 of them phase 3. Colitis, Ulcerative · Korea, Republic of.
Among the 137 studies in Colitis, Ulcerative with a site in Korea, Republic of, this one is the 87th largest by planned enrollment of the 111 interventional ones that give a count, is one of 9 that started in 2025, is one of 8 in phase 4, reaches primary completion later than 24 of the 43 other live ones, and was the 125th registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →24 of the 137 studies in Colitis, Ulcerative with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in Korea, Republic of, United States, Argentina and 30 more countries
Ages 18+
Eli Lilly and Company · Sites in Korea, Republic of, United States, Argentina and 25 more countries
Ages 18–80
Merck Sharp & Dohme LLC · Sites in Korea, Republic of, United States, Canada and 9 more countries
Ages 18–75
Sanofi · Sites in Korea, Republic of, United States, Argentina and 28 more countries
Ages 16–80
Takeda · Sites in Korea, Republic of, United States, Belgium and 11 more countries
Ages 2–17
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 19 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
137 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 48 · Phase 3 59 · Phase 4 8
First in 2005; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 94 is above the median of 70 across 1,237 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 236 across the 111 interventional studies, 334 across the 26 observational. Of the 89 that completed or were terminated, 62 (70%) have results posted.
This tab as a report to print or save as PDF → With an account.
114 of 137 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eisai Korea Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Eisai Co., Ltd. has 5 studies filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
13 of the studies in Colitis, Ulcerative with a site in Korea, Republic of that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
| NCT02808780Janssen Biotech, Inc.An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis | 2026-12-10 |
| NCT07166588Seoul National University HospitalResearch for the Precision Medicine in the Treatment of Inflammatory Bowel Disease | 2026-12-31 |
| NCT05186623Asan Medical CenterPrediction Model for Response to Biologics and Small Molecular Agent for UC | 2026-12-31 |
Add all 13 to your calendar (.ics) → With an account.
Among the 137 studies in Colitis, Ulcerative with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (, , etc.) or a biologic agent based on the investigator's judgement at the screening visit.
Exclusion Criteria:
(ANC) less than (\<) 1*10\^9 cells per liter (/L)
Female participants of who do not agree to use one of the following highly effective methods of from 4 weeks prior to Visit 1 until 4 weeks after the last dose of study drug:
Note: All women will be considered to be of childbearing potential unless they are (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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Filgotinib Maleate
Administered as oral tablets.
Also known as: Jyseleca
Percentage of Participants Achieving Clinical Remission at Week 10 or 22
Time frame: At Week 10 or 22
Percentage of Participants Achieving Clinical Remission at Weeks 10, 22 and 58
Time frame: At Weeks 10, 22 and 58
Percentage of Clinical Responders at Week 10 and 22
Time frame: At Week 10 and 22
Percentage of Participants Achieving Sustained Clinical Remission at Week 58
Time frame: 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.
Time frame: At Weeks 10, 22, and 58
Percentage of Participants Achieving Endoscopic Subscore of 0 at Weeks 10, 22, and 58
Time frame: At Weeks 10, 22, and 58
Percentage of Participants Achieving Nancy Histologic Index (NHI) Histologic Remission at Weeks 10, 22, and 58
Time frame: 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.
Time frame: At Weeks 10, 22, and 58
Percentage of Participants Achieving 6-month Corticosteroid-free Clinical Remission at Week 58
Time frame: At Week 58
Number of Participants With Adverse Events (AEs)
Time frame: Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Laboratory Tests
Time frame: Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame: Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Weight
Time frame: Up to 62 weeks
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Measurements
Time frame: Up to 62 weeks
Duration of Filgotinib Exposure
Time frame: Up to 58 weeks
Percentage of Participants Who Complied to Treatment
Time frame: Up to 58 weeks
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Nov 2027, 29 months after the start.
Of 63 phase 4 interventional studies under Colitis, Ulcerative, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 63. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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