Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).

Official Title

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative Filgotinib Filgotinib Dose A (Induction Study) Filgotinib Dose B (Induction Study) Maintenance Study

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  • 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.
  • A surveillance colonoscopy is required at screening in individuals 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
  • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key Exclusion Criteria:

  • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC San Diego Health System accepting new patients
    La Jolla California 92037 United States
  • Naval Medical Center San Diego accepting new patients
    San Diego California 92134 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02914522
Phase
Phase 3
Study Type
Interventional
Last Updated