Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Launched by GILEAD SCIENCES · Feb 6, 2017

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
• • Moderately or severely active CD
• • Minimum duration of CD of at least 6 months
• • Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
• • Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
• * 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 (TNFα) antagonists
• • Vedolizumab
• • Ustekinumab
• • Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements
• Key Exclusion Criteria:
• • Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
• • Presence of fistulae
• • Evidence of short bowel syndrome
• • Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
• • History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
• • Use of any prohibited concomitant medications as described in the study protocol
• • Active tuberculosis (TB) or history of latent TB that has not been treated
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Officials