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

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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