Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Filgotinib; Placebo
Intervention description: Filgotinib tablets administered orally once daily.; Placebo administered orally once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1372.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of filgotinib
      during induction and maintenance treatment of moderately to severely active Crohn's disease
      (CD) 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 (Study
      GS-US-419-3896).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of CD with a minimum disease duration of 3 months with
             involvement of the ileum and/or colon at a minimum, as determined by histopathology
             and endoscopic assessment

          -  Moderately to severely active CD

          -  Cohort A (Biologic Naïve): 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 and
             immunomodulators

          -  Cohort A (Biologic Experienced): 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) or discontinuation
             of use of at least one of the following agents for reasons other than inadequate
             clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa)
             antagonists, vedolizumab, and ustekinumab

          -  Cohort B (Biologic Experienced): 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): TNFa antagonists,
             vedolizumab, and ustekinumab

        Key Exclusion Criteria:

          -  Current complications of CD such as symptomatic strictures, severe rectal/anal
             stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.

          -  Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
             colitis, or toxic mega-colon

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

          -  Use of any prohibited concomitant medications as described in the study protocol

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.