Clinical Trials List
2017-01-22 - 2023-12-22
Phase III
Recruiting9
Terminated3
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
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Hung-Hsin Lin Division of General Internal Medicine
- 張世慶 Division of General Internal Medicine
- 楊純豪 Division of General Internal Medicine
- 王煥昇 Division of General Internal Medicine
- 姜正愷 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 康瑞文 Division of General Internal Medicine
- Po-Wen Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Taiwan National PI
Co-Principal Investigator
- 林蔚然 Division of General Internal Medicine
- 林偉彬 無
- 陳聰興 Division of General Internal Medicine
- 許振銘 Division of General Internal Medicine
- Cheng-Yu Lin Division of General Internal Medicine
- Ming-Yao Su Division of General Internal Medicine
- Chia-Jung Kuo Division of General Internal Medicine
- Wen-Sy Tsai Division of General Internal Medicine
- 陳俊瑋 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
None
Co-Principal Investigator
- 翁昭旼 Division of General Internal Medicine
- 凃佳宏 Digestive System Department
- Ming-Shiang Wu Digestive System Department
- 謝銘鈞 Division of General Internal Medicine
- SHU-CHEN WEI Division of General Internal Medicine
- YEN-HSUAN NI Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Jen-Wei Chou Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王賀立 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
throughout the duration of the study. Safety evaluations include
documentation of AEs, PE (symptom driven), vital signs, and clinical
laboratory evaluations (hematology, chemistry, and urinalysis). An
ECG will be performed every 48 weeks.
Efficacy: Efficacy will be evaluated in terms of changes in partial MCS.
Biomarkers: Blood samples will be collected at Day 1 and then every 24 weeks
thereafter for the assessment of markers of inflammation and immune
status.
Inclution Criteria
Subjects will be eligible if they meet all of the following inclusion
criteria:
1) 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
2) Must have met all eligibility criteria from a Gilead-sponsored UC
parent protocol
3) Must have completed all required procedures or met protocol
specified efficacy discontinuation criteria in a prior
Gilead-sponsored filgotinib treatment study for UC
4) Females of childbearing potential must have a negative pregnancy
test at Day 1 and must agree to continued monthly pregnancy
testing during use of filgotinib treatment
5) Male subjects and female subjects of childbearing potential who
engage in heterosexual intercourse must agree to use protocol
specified method(s) of contraception as described in Appendix 6,
for the duration described
6) Willingness to refrain from live or attenuated vaccines during the
study and for 12 weeks after last dose of study drug
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to
be enrolled in the study.
1) Subjects who are discontinued from a parent study for reasons
other than disease worsening, or lack of response or remission;
eg, subjects who discontinue for safety or tolerability issues are
not eligible for this study.
2) Known hypersensitivity to the study drug
3) Any chronic medical condition (including, but not limited to,
cardiac or pulmonary disease, alcohol or drug abuse) that, in the
opinion of the Investigator, would make the subject unsuitable for
the study or would prevent compliance with the study protocol
4) Females who may wish to become pregnant and/or plan to
undergo egg donation or egg harvesting for the purpose of current
or future fertilization during the course of the study and for at
least 35 days of the last dose of the study drug
5) Male subjects unwilling to refrain from sperm donation for at
least 90 days after the last dose of study drug
6) Males or females of reproductive potential who are unwilling to
abide by protocol-specified contraceptive methods as defined in
Appendix 6
7) Use of prohibited medications as outlined in Section 5.4
The Estimated Number of Participants
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Taiwan
21 participants
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Global
1000 participants
