Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
- Registration Number
- NCT02914535
- Lead Sponsor
- Galapagos NV
- Brief Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1173
- 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
Key
- 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
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib 100 mg (blinded dosing) Filgotinib Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks Filgotinib 200 mg (blinded dosing) Placebo Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks Filgotinib 100 mg (blinded dosing) Placebo Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks Placebo (blinded dosing) Placebo Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks Filgotinib 200 mg (open-label) Filgotinib Filgotinib 200 mg for up to 336 weeks Filgotinib 200 mg (blinded dosing) Filgotinib Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks Filgotinib 100 mg (open-label) Filgotinib Filgotinib 100 mg for up to 336 weeks
- Primary Outcome Measures
Name Time Method Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests Up to 336 weeks plus 30 days
- Secondary Outcome Measures
Name Time Method Change From Baseline in Components of Mayo Clinic Score (MCS) Baseline and up to 336 weeks
Trial Locations
- Locations (323)
Digestive Health Specialists Of The Southeast
🇺🇸Dothan, Alabama, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
South Denver Gastroenterology, PC
🇺🇸Lone Tree, Colorado, United States
Connecticut GI PC-Research Division
🇺🇸Farmington, Connecticut, United States
UF Clinical Research Center
🇺🇸Gainesville, Florida, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
University of Miami Crohn's and Colitis Center
🇺🇸Miami, Florida, United States
Cordova Research Institute
🇺🇸Miami, Florida, United States
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