CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Filgotinib +1 moredrug
Likely dose
Filgotinib tablet(s) orally once dailyAI-extracted
Key inclusion· 6
  • ✓Age 18-75 years inclusive
  • ✓Moderately or severely active Crohn's disease
  • ✓Minimum 6 months duration of Crohn's disease
  • ✓Diseased small bowel segments present in terminal ileum, distal ileum, or jejunum
Key exclusion· 6
  • ✕Symptomatic or clinically significant strictures or stenosis (obstructive or symptomatic)
  • ✕Presence of fistulae
  • ✕Short bowel syndrome
  • ✕Ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic megacolon

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03046056
NCT03046056Phase 2Completed
CompareCT.gov

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Gilead Sciences·interventional·Posted Feb 8, 2017·Updated Aug 23, 2021

In Brief

A Phase 2 clinical trial evaluating Filgotinib and Placebo to match filgotinib for Small Bowel Crohn's Disease. Completed, enrolled 78 participants across 38 sites in 12 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Bowel Crohn's Disease
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Spain, Ukraine, United Kingdom, United States
CollaboratorsLakefront Biotherapeutics NV

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartApr 11, 2017
Primary CompletionJul 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.4 years ago

Interventions

Filgotinibdrug

Tablet(s) administered orally once daily

Placebo to match filgotinibdrug

Tablet(s) administered orally once daily