Date

2019-10-15

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

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 trial SLCTR/2018/029. 3. 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 4. 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 of the protocol for the duration described 5. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug 6. Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for Crohn’s Disease - SLCTR/2018/029

Next Version

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 enrolled in Gilead-sponsored CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 ( SLCTR/2018/029). 3. 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. 4. 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 of the protocol for the duration described. 5. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug 6. Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for Crohn’s Disease - SLCTR/2018/029