Ulcerative Colitis
Conditions
Interventions
Study sites:
Colombo North Teaching Hospital, Ragama Teaching Hospital Karapitiya, Galle,
Kandy Teaching Hospital, Kandy
The study is divided into 2 parts (induction study and maintenance study). B
Treatment 1 (n = 260): filgotinib 200 mg and placebo-to-match (PTM) filgotinib 100 mg, once daily
Treatment 2 (n = 260): filgotinib 100 mg and PTM filgotinib 200 mg, once daily
Treatment 3 (n = 130):
Sponsors
Gilead Sciences, Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit 2. Documented diagnosis of ulcerative colitis of at least 6 months and with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC. (note: a surveillance colonoscopy is required at screening in individuals with a history of ulcerative colitis for 8 or more years, if one was not performed in the prior 24 months. 3. Moderately to severely active ulcerative colitis Severity index will be evaluated using a centrally read endoscopy score > 2, arectal bleeding score > 1, a stool frequency score > 1 and PGA (physician global assessment) of > 2 as determined by the Mayo clinic scoring system with endoscopy occurring within 14 days to first dose of study drug; total score must be between 6 and 12, inclusive. 4. Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents: corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Exclusion criteria
Exclusion criteria: 1. Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon 2.Active tuberculosis (TB) or history of latent TB that has not been treated 3. Use of any concomitant prohibited medications as described in the protocol (details are available at the SLCTR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction study: 1. Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ] Maintenance study : 2. Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ] [Induction study: 1. Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ] Maintenance study 2. Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ] ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction study: 1. Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ] 2. Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ] 3. Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ] 4. Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ] 5. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ] Maintenance study: 1. Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ] 2. Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ] 3. Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ] 4. Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ] 5. Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ] 6. Proportion of participants achieving MCS remission (alternative definition) at Week 58 [ Time Frame: Week 58 ] 7. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ] [Induction study: 1. Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ] 2. Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ] 3. Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ] 4. Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ] 5. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ] Maintenance study: 1. Proport | — |
Countries
Malaysia,Mexico,Netherlands,New Zealand,Norway,Poland,Portugal,Romania,Russian Federation,Singapore,Slovakia,South Africa,Spain,Sri Lanka,Sweden,Taiwan, Province of China,Ukraine,United Kingdom,United
Contacts
Public ContactProf Arjuna de Silva
Consultant Physician
Outcome results
None listed