A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis
- Conditions
- lcerative Colitis (UC)MedDRA version: 19.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002765-58-FR
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
• 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
• Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
• 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
• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 920
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
• 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 the present study.
• 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
• 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
• Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
• Use of prohibited medications as outlined in the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in UC;Secondary Objective: To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS);Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs;Timepoint(s) of evaluation of this end point: Week 144
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in partial MCS;Timepoint(s) of evaluation of this end point: Week 144