How safe is filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored Filgotinib treatment study in Crohn’s Disease (SLCTR/2018/029) through the conduction of long term safety study

Study sites: 1. Colombo North Teaching Hospital, Ragama. 2. Kandy Teaching Hospital, Kandy

Interventions: Subjects who exit a parent study due to disease worsening or failure to meet response or remission criteria will receive open-label 200 mg filgotinib. Subjects will receive filgotinib or placebo for up to 144 weeks. Approximately 1000 subjects who meet eligibility criteria at Day 01 will receive filgotinib or placebo.

The study medication will consist of blinded-dosing filotinib 200 mg + Placebo to match (PTM) 100 mg or 100 mg filgotinib tablets + PTM 200 mg or PTM 100 mg + PTM 200 mg. Open-label dosing of 200 mg and 100 mg filgotinib tablets for oral administration, to be taken once a day. Placebo to match (PTM) Filgotinib 200 mg and 100 mg tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, macrogol/PEG 3350, polyvinyl alcohol talc, titanium dioxide, iron oxide yellow and iron oxide red.

Standard management will be provided to the trial participants as per local guidelines

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

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 the present study. Details of discontinuation are provided as an annexure.
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 of the protocol
7. Use of prohibited medications as outlined in Section 5.4 of the protocol