ulceration of the colon Ulcerative Collitis
Conditions
Interventions
Treatment Regimen (Cohorts A and B Induction Studies)
Based on protocol eligibility criteria, subjects will be screened for
enrollment in either Cohort A or Cohort B.
Subjects who meet protocol elig
Filgotinib
Ulcerative Collitis
Sponsors
Gilead Sciences
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria (cohorts A and B): Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study. * Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit * Documented diagnosis of UC 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 as follows: a) The criteria for documentation of UC based on endoscopy will be medical record documentation of, or an ileocolonoscopy (full colonoscopy with the intubation of the terminal ileum) report dated * 6 months before enrollment, which shows features consistent with UC, determined by the procedure performing physician b) The criteria for documentation of UC based on histopathology will be medical record documentation of or a histopathology report indicating features consistent with UC as determined by the pathologist * A surveillance colonoscopy is required at screening in subjects with a history of UC for 8 or more years, if one was not performed in the prior 24 months * Moderately to severely active UC as determined by a centrally read endoscopy score * 2, a rectal bleeding score * 1, a stool frequency score * 1 and PGA of * 2 as determined by the Mayo clinic scoring system with endoscopy occurring during screening; total score must be between 6 and 12, inclusive * May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the noted times): a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must be stable for first 10 weeks after randomization b) Azathioprine, 6-MP or MTX provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must be stable for first 10 weeks after randomization c) 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 first 14 weeks after randomization;Cohort A (Biologic-naïve) Induction Study Inclusion Criteria, Cohort A ONLY Subjects must meet all of the additional following inclusion criteria to be eligible for participation in Cohort A Induction Study. 1) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines): a) Corticosteroids i. Active disease despite a history of at least an induction regimen of a dose equivalent to oral prednisone 30 mg daily for 2 weeks or intravenously (IV) for 1 week, OR ii. Two failed attempts to taper steroids below a dose equivalent of 10 mg daily prednisone, OR iii. History of steroid intolerance including, but not limited to, Cushing*s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, serious infections, depression, allergic reactions, mood disturbances, or any other condition that contributed to discontinuation of the agent;b) Immunomodulators i. Active disease despite a history of at least a 12-week regimen of oral azathioprine (* 2 m
Exclusion criteria
Exclusion criteria: Main exclusion criteria (Cohorts A and B): * Should not have Crohn*s disease, undetermined colitis, Ischemic colitis, Fulminant colitis, ulcerative proctitis or toxic megacolon * Should not have active tuberculosis (tb) or a history of latent tb that is untreated * Should not use any prohibited co-medications such as described in the protocol Cohort A (Biologic naïve) induction research Main Exclusion criteria, ONLY for cohort A: * No previous or current treatment with TNF-*-antagonists inclusive (but not limited to) infliximab, adalimumab, golimumab, certolizumab or biosimilar agents, at any moment * No previous or current treatment with vedolizumab, at any moment;Cohort B (biologic previously treated) induction research Main exclusion criteria, ONLY cohort B * May not have been treated with TNF-*-antagonist or vedolizumab * 8 weeks before screening, or another biological * 8 weeks before screening or within 5 times the half-life of the biological before screening, whichever is the longest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy will be assessed by EBS remission, defined as an endoscopic subscore (based on central reading) of 0 or 1 (referencing the Mayo Score), rectal bleeding subscore of 0, and at least a 1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will also be assessed using the full MCS composed of 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and PGA), ranging from 0 to 12. Assessments during non-endoscopic visits may use the partial MCS, which includes all components except flexible sigmoidoscopy/colonoscopy. Geboes histologic remission will be assessed using the Geboes histologic scores composed of 6 different grades for evaluation of disease severity in UC. | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (the Republic of), Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Ukraine, United Kingdom, United States of America
Outcome results
None listed