Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
- Conditions
- Health Condition 1: null- Ulcerative Colitis
- Registration Number
- CTRI/2017/09/009708
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
1) Must have the ability to understand and sign a written 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
Key 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, would make the subject unsuitable for the study or would prevent compliance with the study protocol
• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the participants
• Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory TestsTimepoint: Up to 336 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Components of Mayo Clinic Score or MCSTimepoint: Baseline and up to 336 weeks