Risankizumab in Moderately to Severely Active Crohn's Disease

Condition: Crohn's disease

Eligibility

Key Inclusion Criteria

  • Entry and completion of study M16-006, M15-991 or M15-989
  • Achieved clinical response at the last visit of M16-006 or M15-991
  • If female, must meet criteria for specific contraception recommendations

Key Exclusion Criteria

  • Considered by the researcher, for any reason, to be an unsuitable candidate for the study
  • Known hypersensitivity to risankizumab

Full Study Name

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 (IRB no. STUDY00000064)

Summary

The purpose of this study is to evaluate the effectiveness and safety of various doses of an investigational drug called risankizumab, and to determine how well it works as maintenance therapy and long-term therapy for patients with moderate to severe Crohn’s disease who have completed participation in the risankizumab studies M16-006, M15-991 or M15-989.

Participants will be randomly assigned to receive either risankizumab or a placebo (an inactive substance). Risankizumab works by blocking the actions of a protein involved in the immune response that plays an important role in the development of chronic inflammation. The study also aims to learn whether a biomarker test can determine how well the body responds to 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, is a paid professional consultant to the sponsor of this study.

Phase

Phase III

Principal Investigator

Gil Melmed, MD

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