NIH SUBSTUDY:Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single Infusions of AIN457 in Patients With Moderate to Severe Active Crohn's Disease

Purpose:

• Crohn's disease is an inflammatory bowel disease with major symptoms such as diarrhea and abdominal pain when the disease is in an active stage.
• AIN457 is a protein developed by NOVARTIS that is used to stop the action of Interleukin-17 (IL-17), a protein made by the body that contributes to many different kinds of inflammatory diseases, including Crohn's disease. AIN457 is being developed for the potential treatment of various inflammatory diseases like rheumatoid arthritis and psoriasis, but has not been tested for suitability in people with Crohn's disease.

Objectives:

• The main objective of the NIH substudy is to obtain additional blood and gut biopsy tissue for monitoring biochemical changes in immune variables in response to study drug or placebo.
• The main objective of the main multicenter study (sponsored by NOVARTIS) is to determine whether AIN457 is safe and effective in the treatment of Crohn's disease, and if effective, how long the effect will remain.

Eligibility: