A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree

INTERVENTION: Product Name: Kappaproct Product Code: DIMS0150 Pharmaceutical Form: Rectal solution Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use CONDITION: Active ulcerative colitis in steroid refractory or steroid dependent patients PRIMARY OUTCOME: Main Objective: The primary objective is to evaluate the clinical response of Kappaproct given as a single dose of 30 mg compared to placebo. Responders are defined as patients showing a decrease in Disease Activity Index (DAI) score of at least 3 points, coupled with a reduction in levels of active NF‐kB in intestinal mucosa analysed in biopsies from the patients. The differences in number of responders in the two groups (active dose and placebo) will be assessed. Primary end point(s): Response after one week treatment (30 mg Kappaproct or placebo), defined as a decrease in DAI score (a responder should have a decrease in DAI score of at least 3) coupled with a reduction in the level of active NF‐kB in biopsies.; ; Secondary Objective: * In an explorative manner study the immune response in blood and biopsies from the patients before and after treatment with Kappaproct and by analyzing blood from dosed patients monitor cytokine expression and other factors believed to play a role in inflammation.; * To perform histopathological evaluation; * To follow patients for 6 months after treatment. ; * To evaluate safety and tolerability of Kappaproct in one dose of 30 mg. ; * To confirm the diagnosis in biopsies using a diagnostic method based on real time polymerase chain reaction (PCR) analyses. ; INCLUSION CRITERIA: 1. Male or female patients, =18 years of age. 2. Well established UC, of mild or moderate degree, defined as a Schroeder DAI score of 6‐11. 3. GCS treatment resistant or dependent (=5mg per day of prednisolon or equivalent treatment for 4 weeks) or in cases of a known history of clinical steroid resistance not responding adequately to =5mg per day of prednisolon or equivalent treatment for =2 weeks. 4. Endoscopy score of =2. 5. At least one previous verified attack of UC within the last 3 years prior to randomization. 6. Current UC relapse with onset =12 months prior to randomization. 7. Current UC disease location should extend more than 10 cm from the anal verge but not beyond the left colonic flexure, as verified by an appropriate endoscopic method (rigid sigmoidoscopy/colonoscopy). 8. Visible blood in stools at least once within a week prior to randomization. 9. Infectious cause ruled out through negative stool culture. 10. If ong