GS-US-419-3895 – Combined Phase 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 Crohn’s Disease

Age – Adult (18+)
Gender – Female, Male
Disease Type – crohns-disease
Severity – Moderate, Severe

Eligibility Criteria

  • Males or non-pregnant, non-lactating females, ages 18 to 80 years, inclusive
    Documented diagnosis of Crohn’s Disease with a minimum disease duration of 6 months
    Moderately to severely active Crohn’s Disease
    Inadequate response, loss of response, or intolerance to prior treatment
    Not experiencing complications of Crohn’s Disease such as symptomatic strictures, severe rectal/anal stenosis, fistulae, short bowel syndrome, etc.
    No presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
    No active tuberculosis (TB) or history of latent TB that has not been treated