Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

Exclusion Criteria

• •1. Lack of effective contraception
• •2. Women who are pregnant or breastfeeding;
• •3. Strong analgesia NSAID use
• •4. Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy.
• •5. Rectal products
• •6. Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
• •7. All other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the Screening Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer)
• •8. Anal sphincter dysfunction
• •9. Infections to cytomegalovirus or Clostridium Difficile
• •10. Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses
• •11. Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial