Date

2019-01-16

Protocol

Protocol changed

Item Changed

Intervention (Study sites)

Previous Version

Study sites Colombo North Teaching Hospital, Ragama Teaching Hospital Karapitiya, Galle Kandy Teaching Hospital, Kandy. This is a combined Phase 3 double-blind, randomized, placebo-controlled studies to evaluate the efficacy and safety of filgotinib in the induction and maintenance of remission in subjects with moderately to severely active CD. The study is divided into 2 parts (induction study and maintenance study). Based on protocol eligibility criteria, subjects will be screened for enrollment in either Cohort A (biologic naïve patients) or Cohort B (biologic experienced patients). Subjects who meet protocol eligibility criteria will be assigned to the respective Cohort and subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments to the induction study as follows: Treatment 1 (n = 220): filgotinib 200 mg and placebo-to-match (PTM) filgotinib 100 mg, once daily Treatment 2 (n = 220): filgotinib 100 mg and PTM filgotinib 200 mg, once daily Treatment 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily The study medication will consist of 200 mg and 100 mg filgotinib tablets for oral administration, and PTM 200 mg and 100 mg filgotinib tablets for oral administration. Subjects in Cohort A and B who complete the Induction Study and achieve either clinical remission by PRO2 (patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency) or endoscopic response by SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 10 will be re-randomized into the Maintenance Study at Week 11. Subjects who achieve neither clinical remission by PRO2 nor endoscopic response at Week 10 will have the option to enter a separate Long-Term Extension (LTE) study (Gilead Study GS-US-419-3896). Standard management be offered to all arms given that the allowed concomitant medication(s) for Crohn’s Disease (CD) must be maintained at a stable dose for the noted time without dosing alteration or discontinuation. The allowed medications for CD are as follows: • Oral 5-ASA compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must be stable for the first 10 weeks after randomization • Azathioprine, 6-MP, or MTX provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must be stable for the first 10 weeks after randomization • Oral corticosteroid therapy (prednisone prescribed at a stable dose = 30 mg/day or budesonide prescribed at a stable dose of = 9 mg/day) provided the dose prescribed has been stable for 2 weeks prior to randomization; dose must be stable for the first 14 weeks after randomization • Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose prescribed has been stable for 2 weeks prior to randomization. Dose must remain stable for the first 10 weeks after randomization. Subjects who are on cyclic therapy must continue their standard low-dose regimen without change for the first 10 weeks after randomization.

Next Version

Study sites Colombo North Teaching Hospital, Ragama Teaching Hospital Karapitiya, Galle Kandy Teaching Hospital, Kandy, Teaching Hospital, Kurunegala, National Hospital of Sri Lanka This is a combined Phase 3 double-blind, randomized, placebo-controlled studies to evaluate the efficacy and safety of filgotinib in the induction and maintenance of remission in subjects with moderately to severely active CD. The study is divided into 2 parts (induction study and maintenance study). Based on protocol eligibility criteria, subjects will be screened for enrollment in either Cohort A (biologic naïve patients) or Cohort B (biologic experienced patients). Subjects who meet protocol eligibility criteria will be assigned to the respective Cohort and subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments to the induction study as follows: Treatment 1 (n = 220): filgotinib 200 mg and placebo-to-match (PTM) filgotinib 100 mg, once daily Treatment 2 (n = 220): filgotinib 100 mg and PTM filgotinib 200 mg, once daily Treatment 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily The study medication will consist of 200 mg and 100 mg filgotinib tablets for oral administration, and PTM 200 mg and 100 mg filgotinib tablets for oral administration. Subjects in Cohort A and B who complete the Induction Study and achieve either clinical remission by PRO2 (patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency) or endoscopic response by SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 10 will be re-randomized into the Maintenance Study at Week 11. Subjects who achieve neither clinical remission by PRO2 nor endoscopic response at Week 10 will have the option to enter a separate Long-Term Extension (LTE) study (Gilead Study GS-US-419-3896). Standard management be offered to all arms given that the allowed concomitant medication(s) for Crohn’s Disease (CD) must be maintained at a stable dose for the noted time without dosing alteration or discontinuation. The allowed medications for CD are as follows: • Oral 5-ASA compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must be stable for the first 10 weeks after randomization • Azathioprine, 6-MP, or MTX provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must be stable for the first 10 weeks after randomization • Oral corticosteroid therapy (prednisone prescribed at a stable dose = 30 mg/day or budesonide prescribed at a stable dose of = 9 mg/day) provided the dose prescribed has been stable for 2 weeks prior to randomization; dose must be stable for the first 14 weeks after randomization • Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose prescribed has been stable for 2 weeks prior to randomization. Dose must remain stable for the first 10 weeks after randomization. Subjects who are on cyclic therapy must continue their standard low-dose regimen without change for the first 10 weeks after randomization.