Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.

Inclusion criteria

• Men and women, 18 years of age and older
• Signed and dated informed consent to participate before any study-related procedures are performed
• Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed
• A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive
• Female subjects who are not surgically sterile or postmenopausal must use medically acceptable methods of birth control during and for 30 days after the treatment period.
• HCT 30% or greater
• WBC 3.5 x 109/L or greater
• Platelets 100 x 109/L or greater
• Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less
• Adequate hepatic function defined as: ALT/SPGT, AST/SGOT 2.0 x ULN or less; total bilirubin 1.25 x ULN or less, alkaline phosphatase 1.5 x ULN or less
• Female subjects of childbearing potential must have negative urine pregnancy test results prior to randomization
• A stool sample must be taken at screening and analyzed by a local laboratory for enteric pathogens, pathogenic ova and parasites, and Clostridium difficile toxin, and reported negative prior to randomization.
• C-reactive protein value must be 1.0 mg/dL or more, unless there are obvious manifestations of currently active Crohn's disease such as positive observations on endoscopy, other positive indications by laboratory test results, or the subject has had a previous intestinal resection for Crohn's disease.

Exclusion criteria

• Nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight
• Body weight less than 40 kg or more than 100 kg
• Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage
• Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)
• Expected to require surgical therapy for Crohn's disease or Crohn's disease related complications within 12 weeks of screening. If an abscess is present, it should be drained at least 3 weeks before pre-screening
• History of ulcerative colitis within 6 months of screening visit
• Cushing's syndrome
• Known HIV infection, or symptoms or signs of HIV infection
• Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening or baseline
• Evidence of chronic hepatitis B or C viral infection
• Decompensated liver disease
• Clinically significant ECG abnormalities
• History of angina or cardiac arrhythmia requiring drug or device intervention or clinically significant congestive heart failure or other clinically significant cardiac disease
• History of myocardial infarction within 12 months of screening
• History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)
• History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
• Known substance abuse in the previous 2 years
• Nursing mothers or pregnant women
• Use of native GLP-2, growth hormone, or growth factors within 3 months of signing informed consent
• Use of any of the prior or concomitant medications described in section 5.4, except as specified
• Known hypersensitivity to any of the active or inactive constituents of ALX-0600