Gilead Diversity: Filgotinib in Crohn's Disease

Condition: Crohn's Disease

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Documented diagnosis of Crohn’s disease with a minimum disease duration of 6 months, with involvement of the ileum and/or colon at a minimum
  • Moderately or severely active Crohn’s disease

Key Exclusion Criteria

  • Pregnant or lactating
  • Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
  • Currently has complications of Crohn’s disease

Full Study Name

Combined Phase III, 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 (IRB no. 48546)

Summary

This study focuses on individuals diagnosed with Crohn’s disease, an inflammatory disease of the gastrointestinal tract (digestive tract). The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe Crohn’s disease. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Phase

Phase III

Principal Investigator

Gil Melmed, MD

Contact
Elizabeth Khanishian
Phone: 310-423-2041
Email: elizabeth.khanishian@cshs.org