Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Filgotinib Dose A (Induction Study)
Filgotinib dose A + placebo to match filgotinib dose B for 10 weeks
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Experimental
Filgotinib Dose B (Induction Study)
Filgotinib dose B + placebo to match filgotinib dose A for 10 weeks
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Placebo Comparator
Placebo (Induction Study)
Placebo to match dose A + placebo to match dose B for 10 weeks
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Experimental
Maintenance Study
Participants who meet response or remission criteria at Week 10 will continue into Maintenance Study and will receive filgotinib and/or placebo for 48 weeks.
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

Vanderbilt University
Nashville, Tennessee 37212

More Details

NCT ID
NCT02914522
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.