Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease

The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Inclusion Criteria:

• Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
• Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and < 450 at baseline
• Evidence of active inflammation

Exclusion Criteria:

• Short bowel syndrome
• Stricture with obstructive symptoms within 3 months
• Bowel surgery within 3 months
• Ileostomy and/or colostomy
• Any gastric or intestinal pouch
• Ulcerative colitis
• Evidence of an infected abscess
• Bowel perforation or evidence of noninflammatory obstruction during the 6 months
• Stool positive for C. Difficile toxin at screening
• Presence of active infection requiring treatment
• Serious infection within 8 weeks
• Significant concurrent medical conditions
• Pregnant or breast feeding
• Significant Laboratory abnormalities
• Any anti-tumor necrosis factor (TNF) agent within 2 months
• Steroid enemas within 2 weeks
• Tysabri (natalizumab) within 1 year
• Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
• Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months