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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Gilead Sciences
 
Acronym KP IRB No.
1357657
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Documented diagnosis of Crohn's Disease.
 
Purpose
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 (Gilead Study GS-US-419-3896).
 
Detailed Description
Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ]. Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ]. Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ]. Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 }.
 
Gender Age Limit
Male & Female 18 - 75 years
 
Inclusion Criteria
  • 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 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
  • 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
  • Key Exclusion Criteria
  • Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, 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
  • Please contact study team for more eligibility criteria.

 
Keywords and/or Specific Medical Conditions
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Digestive System Diseases
  • Intestinal Diseases
  • Gastroenteritis
  • Gastroenterology
  • Gastrointestinal Diseases
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Gastroenterology


Principal Investigator:
Fernando S Velayos, MD
Contact Information:
- KPNC Gastroenterology
-catherine.vowels@kp.org
-San Francisco Medical Center


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