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

1. Men and women, 18 years of age and older

2. Signed and dated informed consent to participate before any study-related procedures
are performed

3. Diagnosis of Crohn's disease for at least 6 months that has been documented and
confirmed

4. A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive

5. 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.

6. HCT 30% or greater

7. WBC 3.5 x 109/L or greater

8. Platelets 100 x 109/L or greater

9. Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less

10. 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

11. Female subjects of childbearing potential must have negative urine pregnancy test
results prior to randomization

12. 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.

13. 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

1. Nutritionally compromised subjects requiring enteral or parenteral therapy to
maintain weight

2. Body weight less than 40 kg or more than 100 kg

3. Bowel obstruction or any condition that may predispose to its development, intestinal
perforation, or significant gastrointestinal hemorrhage

4. Current ileostomy or colostomy or extensive external fistulization (more than 3
external fistulae which are expressible with gentle compression)

5. 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

6. History of ulcerative colitis within 6 months of screening visit

7. Cushing's syndrome

8. Known HIV infection, or symptoms or signs of HIV infection

9. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at
time of screening or baseline

10. Evidence of chronic hepatitis B or C viral infection

11. Decompensated liver disease

12. Clinically significant ECG abnormalities

13. History of angina or cardiac arrhythmia requiring drug or device intervention or
clinically significant congestive heart failure or other clinically significant
cardiac disease

14. History of myocardial infarction within 12 months of screening

15. History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known
congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)

16. 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

17. Known substance abuse in the previous 2 years

18. Nursing mothers or pregnant women

19. Use of native GLP-2, growth hormone, or growth factors within 3 months of signing
informed consent

20. Use of any of the prior or concomitant medications described in section 5.4, except
as specified

21. Known hypersensitivity to any of the active or inactive constituents of ALX-0600