Date

2020-03-12

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study sites 1. National Hospital of Sri Lanka 2. Kurunegala Teaching Hospital 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

Next Version

Study sites 1. Colombo North Teaching Hospital, Ragama 2. Teaching Hospital Karapitiya, Galle 3. Kandy Teaching Hospital, Kandy 4. National Hospital of Sri Lanka, Colombo Interventions: Subjects who exit a parent study due to disease worsening or failure to meet response or emission criteria will receive open-label 200 mg filgotinib. Subjects will receive filgotinib or placebo for up to 432 weeks. Approximately 1000 subjects who meet eligibility criteria at Day 01 will receive filgotinib or placebo.