Filgotinib Maleate
DrugAdministered as oral tablets.
Other names: Jyseleca
NCT Number: NCT06964113
The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
This study is active but is not currently recruiting participants.
Notify Me19 year–64 year
All sexes
Interventional
Phase 4
Eisai Site #13, Busan, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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).
Administered as oral tablets.
Other names: Jyseleca
Time frame: At Week 10 or 22
Time frame: At Weeks 10, 22 and 58
Time frame: At Week 10 and 22
Time frame: At Week 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.
Time frame: At Weeks 10, 22, and 58
Time frame: 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.
Time frame: At Week 58
Time frame: Up to 62 weeks
Time frame: Up to 62 weeks
Time frame: Up to 62 weeks
Time frame: Up to 62 weeks
Time frame: Up to 62 weeks
Time frame: Up to 58 weeks
Time frame: Up to 58 weeks
Eisai Korea Inc.
Industry
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
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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