Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis

Inclusion Criteria:

* Age, \>18 years, AND
* Capable of understanding the purpose and risks of the study and have provided a signed and dated written IC, AND
* Prior to the study baseline, been treated with oral steroid medication, of which \> 2 weeks on oral prednisone equivalent of at least 40mg/day, and still have:

  * active ulcerative colon disease documented by a MAYO score of 6-11, and
  * active ulcerative colon disease documented by a MTWSI score of 7-15

OR

* Prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Subjects have been treated for a minimum of 12 weeks, and still have:

  * chronic active ulcerative colon disease documented by a MAYO score of 6-11, and
  * chronic active ulcerative colon disease documented by a MTWSI score of 7-15

OR

* Prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as:

  * chronic active ulcerative colon disease documented by a MAYO score of 6-11, and
  * chronic active ulcerative colon disease documented by a MTWSI score of 7-15.

Exclusion Criteria:

* UC, requiring immediate surgical, endoscopic, or radiological intervention; including massive haemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or peri-anal abscesses) or toxic colon,
* history of large bowel surgery,
* history of serious infections,
* positive stool cultures, including Clostridium difficile,
* significant organ dysfunction,
* pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives,
* treatment with:

  1. an altered dose of any 5-ASA preparation within 4 weeks of screening,
  2. an altered dose of azathioprine or mercaptopurine within 4 weeks of screening (stable dosage of immunosuppressives is allowed), or start of azathioprine in the last 3 months prior to baseline,
  3. probiotics, antibiotics within 1 month, methotrexate or cyclosporine within 2 months prior to screening,
  4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNFα therapy) within 2 months of screening.