Clinical Trials List
2017-01-22 - 2023-12-22
Phase III
Terminated4
Study ended1
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
Pharmaceutical Research Associates Taiwan Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/24
Investigators and Locations
Co-Principal Investigator
- Ming-Shiang Wu Digestive System Department
- 謝銘鈞 Division of General Internal Medicine
- 翁昭旼 Division of General Internal Medicine
- YEN-HSUAN NI Division of General Internal Medicine
- SHU-CHEN WEI Division of General Internal Medicine
- 凃佳宏 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Audit
None
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
- Chia-Jung Kuo Division of General Internal Medicine
- 陳聰興 Division of General Internal Medicine
- Cheng-Yu Lin Division of General Internal Medicine
- 林蔚然 Division of General Internal Medicine
- Wen-Sy Tsai Division of General Internal Medicine
- 許振銘 Division of General Internal Medicine
- Ming-Yao Su Division of General Internal Medicine
- 林偉彬 Division of General Internal Medicine
- 陳俊瑋
The Actual Total Number of Participants Enrolled
1 Study ended
Audit
None
Condition/Disease
Objectives
Test Drug
Filgotinib (GS-6034)
Active Ingredient
Filgotinib
Dosage Form
Film-coated tablet
Dosage
200 mg
Endpoints
Inclution Criteria
Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
Females of childbearing potential must have a negative pregnancy test at Day 1
Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described
Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Exclusion Criteria
Known hypersensitivity to the study drug
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
Use of prohibited medications as outlined in the protocol
The Estimated Number of Participants
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Taiwan
21 participants
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Global
1000 participants
