Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Abrilumab; Placebo
Intervention description: Administered by subcutaneous injection.; Placebo matching to abrilumab administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: IBD, Crohn's Disease

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.
    

Eligibility 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