Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.

Key facts

Study ID

NCT01696396

Run by

Amgen

People needed

254

Starts

2012-12-04

Expected to finish

2018-04-10

Last updated by the study team

2019-06-27

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 baseline
• Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
• Evidence of active inflammation within 12 weeks prior to baseline
• Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
• Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
• Subject has no known history of active tuberculosis and has a negative test for tuberculosis during screening

You may not qualify if…

• Short bowel syndrome
• Stricture with obstructive symptoms within 3 months
• Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
• Ileostomy and/or colostomy
• Any gastric or intestinal pouch
• Evidence of an infected abscess
• Bowel perforation or evidence of non-inflammatory obstruction during the 6 months prior to baseline
• Stool positive for C. difficile toxin at screening
• Any uncontrolled or clinically significant systemic disease
• Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV)
• Any underlying condition that predisposes subject to infections
• Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of baseline
• Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids within protocol-specified time periods.
• Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab, efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any form of cell-based transplantation
• Received treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
• Significant laboratory abnormalities
• Pregnant or breast feeding

Where it is running

• Research Site — Dothan, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Goodyear, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — La Jolla, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Sanford, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Arlington Heights, Illinois, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Chesterfield, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Mexico, Missouri, United States
• Research Site — Great Neck, New York, United States
• Hospital — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — Mentor, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Seattle, Washington, United States
• Research Site — Innsbruck, Austria
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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