AMG 827 in Subjects With Moderate to Severe Crohn's Disease

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate to severe Crohn's disease. Patients will randomly receive either AMG 827 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Brodalumab

Criteria

Inclusion Criteria:

• Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating Study Product

• 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-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