Gilead Selection: Filgotinib in Ulcerative Colitis

Condition: Ulcerative Colitis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Documented diagnosis of ulcerative colitis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active ulcerative colitis

Key Exclusion Criteria

  • Pregnant or lactating
  • Exhibits acute severe ulcerative colitis
  • Known hypersensitivity to filgotinib

Full Study Name

Combined Phase IIb/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 Ulcerative Colitis (IRB no. 48583)

Summary

This study focuses on patients diagnosed with ulcerative colitis, an inflammatory disease of the large intestines. 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 ulcerative colitis. 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 IIb/III

Principal Investigator

Gil Melmed, MD

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