Risankizumab in Crohn's Disease

Condition: Crohn's disease

Eligibility

Key Inclusion Criteria

  • 18-80 years old (Where locally permissible, individuals who are 16 to <18 years old and who meet specific criteria are eligible.)
  • Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline visit
  • Crohn's disease activity index score 220–450 at baseline

Key Exclusion Criteria

  • Current diagnosis of ulcerative colitis or indeterminate colitis
  • Individuals on CD-related antibiotics who have not been on stable doses for greater than, or discontinued within, 14 days prior to baseline
  • Individuals on oral aminosalicylates who have not been on stable doses for greater than, or discontinued within, at least 14 days prior to baseline

Full Study Name

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease (IRB no. 0060)

Summary

This study focuses on individuals diagnosed with Crohn's disease and who are experiencing symptoms such as diarrhea, abdominal pain and/or a sudden and constant urge to move their bowels. The purpose of the study is to evaluate the efficacy and safety of various doses of an investigational drug called risankizumab and to determine how well it works in patients with moderate to severe Crohn's disease.

Risankizumab works by blocking the actions of a protein known as interleukin 23, which is involved in the immune response and plays an important role in the development of chronic inflammation. Participants will be randomly assigned to receive either risankizumab or placebo (inactive substance). Researchers also aim to learn whether a biomarker test can be used to determine how well the body responds to the treatment. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease.

Financial disclosure: Gil Melmed MD, the principal investigator on this study, receives payment from the company sponsoring this study and is a paid professional consultant to the sponsor.

Phase

Phase III

Principal Investigator

Gil Melmed, MD

Contact
Melissa Hampton
Phone: 310‐423‐0035
Email: melissa.hampton@cshs.org