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Ulcerative ColitisPhase 4NCT06964113

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

A Phase 4 study testing Filgotinib Maleate in people with Ulcerative Colitis, run by Eisai Korea Inc. at 19 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 64 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Filgotinib Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
19 sitesSouth Korea
Study dates
11 Jun 2025to 30 Nov 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult participants aged 19 to 64 years at the time of written consent
  • Participants must meet both of the following conditions:
  • 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.
  • Participant who is considered reliable by the investigator regarding provision of information, and is willing to comply with the study protocol procedures

Who cannot join

  • Participants with hypersensitivity to the active substance or to any of the excipients listed in the approved label of filgotinib
  • Participants with active infections, including serious infections (example [e.g.], sepsis) or local infections
  • 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).
  • Participants with severe hepatic impairment (Child-Pugh C)
  • Participants with moderate or greater renal impairment (Creatinine Clearance [CrCl] less than (<) 60 milliliter per minute [mL/min])
  • Participants who meet any of the following laboratory values:
Show all 22Show fewer
  • 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
  • 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.
  • 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).
  • Participants with hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
  • Participants with a history of prior treatment with Janus kinase (JAK) inhibitor
  • Participants currently participating in other clinical study or participants who used other investigational product/medical device within 4 weeks of the screening visit
  • Participants deemed inappropriate to participate in this study at the investigator's discretion.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

South Korea19 sites

  • Eisai Site #13

    Busan

  • Eisai Site #15

    Busan

  • Eisai Site #8

    Busan

  • Eisai Site #6

    Daegu

  • Eisai Site #2

    Daejeon

  • Eisai Site #16

    Gyeonggi-do

  • Eisai Site #4

    Gyeonggi-do

  • Eisai Site #11

    Gyeongnam

  • Eisai Site #18

    Jungnam

  • Eisai Site #7

    Jungnam

  • Eisai Site #10

    Seoul

  • Eisai Site #12

    Seoul

  • Eisai Site #14

    Seoul

  • Eisai Site #17

    Seoul

  • Eisai Site #19

    Seoul

  • Eisai Site #1

    Seoul

  • Eisai Site #3

    Seoul

  • Eisai Site #5

    Seoul

  • Eisai Site #9

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
Filgotinib Maleate
Keywords
Jyseleca, Filgotinib maleate
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filgotinib MaleateDrug

    Also called Jyseleca

    Administered as oral tablets.

Study groups in NCT06964113
Study groupRoleWhat they receive
Filgotinib Maleate 200 milligram per day (mg/day)ExperimentalNot described
Receives: Drug: Filgotinib Maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Clinical Remission at Week 10 or 22

    Measured: At Week 10 or 22

Secondary outcomes (15)

  1. Percentage of Participants Achieving Clinical Remission at Weeks 10, 22 and 58

    Measured: At Weeks 10, 22 and 58

  2. Percentage of Clinical Responders at Week 10 and 22

    Measured: At Week 10 and 22

  3. Percentage of Participants Achieving Sustained Clinical Remission at Week 58

    Measured: At Week 58

  4. 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.

    Measured: At Weeks 10, 22, and 58

  5. Percentage of Participants Achieving Endoscopic Subscore of 0 at Weeks 10, 22, and 58

    Measured: At Weeks 10, 22, and 58

  6. Percentage of Participants Achieving Nancy Histologic Index (NHI) Histologic Remission at Weeks 10, 22, and 58

    Measured: At Weeks 10, 22, and 58

  7. 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.

    Measured: At Weeks 10, 22, and 58

  8. Percentage of Participants Achieving 6-month Corticosteroid-free Clinical Remission at Week 58

    Measured: At Week 58

  9. Number of Participants With Adverse Events (AEs)

    Measured: Up to 62 weeks

  10. Number of Participants With Clinically Significant Abnormal Laboratory Tests

    Measured: Up to 62 weeks

  11. Number of Participants With Clinically Significant Abnormal Vital Signs

    Measured: Up to 62 weeks

  12. Number of Participants With Clinically Significant Abnormal Weight

    Measured: Up to 62 weeks

  13. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Measurements

    Measured: Up to 62 weeks

  14. Duration of Filgotinib Exposure

    Measured: Up to 58 weeks

  15. Percentage of Participants Who Complied to Treatment

    Measured: Up to 58 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start11 Jun 2025
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06964113
Sponsor's protocol ID
GS6034-M082-402
Status last verified
Jun 2026
First submitted
2 May 2025
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Filgotinib Maleate in people with Ulcerative Colitis, run by Eisai Korea Inc. at 19 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 10 or 22 (time frame: At Week 10 or 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06964113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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