Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

Exclusion Criteria

• •1. Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
• •2. History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
• •3. Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy \>8 weeks prior to screening were eligible.
• •4. Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
• •5. Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
• •6. Patients with known severe fixed symptomatic stenosis of the small or large intestine.
• •7. Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
• •8. Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
• •9. Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
• •10. Patients with previous diagnosis of, or known, malignancies.
• •11. Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
• •12. History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
• •13. Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
• •14. Women who were pregnant or breast-feeding.
• •15. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
• •16. Patients who had received CNI-1493 in the past.
• •17. More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication