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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01150890

Run by

Amgen

People needed

130

Starts

2010-11-09

Expected to finish

2011-10-15

Last updated by the study team

2022-01-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Dothan, Alabama, United States
• Research Site — Lowell, Arkansas, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Hammond, Louisiana, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Mexico, Missouri, United States
• Research Site — Egg Harbor, New Jersey, United States
• Research Site — Great Neck, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Wilmington, North Carolina, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Logan, Utah, United States
• Research Site — Ogden, Utah, United States
• Research Site — Kurralta Park, South Australia, Australia
• Research Site — Box Hill, Australia
• Research Site — Fitzroy, Australia
• Research Site — Fremantle, Australia
• Research Site — Bonheiden, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium

Full record on ClinicalTrials.gov

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