The primary purpose of this study is to evaluate the efficacy of filgotinib in establishing clinical remission at Week 10 or 22.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Administered as oral tablets.
Eisai Site #13
Busan, South Korea
Eisai Site #15
Busan, South Korea
Eisai Site #8
Busan, South Korea
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
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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
...and 9 more locations
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