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NCT Number: NCT06964113

A Study of Filgotinib 200 mg in Korean Participants 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eisai Site #13, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants aged 19 to 64 years at the time of written consent
  • 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.

  • Participant who is considered reliable by the investigator regarding provision of information, and is willing to comply with the study protocol procedures

Exclusion criteria

  • 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:
  • 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.

Treatment and study plan

Filgotinib Maleate

Drug

Administered as oral tablets.

Other names: Jyseleca

Primary outcomes

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

    Time frame: At Week 10 or 22

Secondary outcomes

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

    Time frame: At Weeks 10, 22 and 58

  2. Percentage of Clinical Responders at Week 10 and 22

    Time frame: At Week 10 and 22

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

    Time frame: At Week 58

  4. Percentage of Participants Achieving Mayo Clinic Score (MCS) Remission at Weeks 10, 22, and 58

    Time frame: 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.

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

    Time frame: At Weeks 10, 22, and 58

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

    Time frame: At Weeks 10, 22, and 58

  7. Percentage of Participants Achieving MCS Remission (Alternative Definition) at Weeks 10, 22, and 58

    Time frame: 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.

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

    Time frame: At Week 58

  9. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 62 weeks

  10. Number of Participants With Clinically Significant Abnormal Laboratory Tests

    Time frame: Up to 62 weeks

  11. Number of Participants With Clinically Significant Abnormal Vital Signs

    Time frame: Up to 62 weeks

  12. Number of Participants With Clinically Significant Abnormal Weight

    Time frame: Up to 62 weeks

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

    Time frame: Up to 62 weeks

  14. Duration of Filgotinib Exposure

    Time frame: Up to 58 weeks

  15. Percentage of Participants Who Complied to Treatment

    Time frame: Up to 58 weeks

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 9, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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