A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

Inclusion Criteria:

• Age 18 to 65 inclusive
• Male, non-child-bearing female or fertile female with appropriate contraception.
• Mild to moderate confirmed active ulcerative colitis
• Able and willing to give informed consent

Exclusion Criteria:

• Colitis of other cause
• Pregnancy, inadequate contraception for fertile female patients
• Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
• Other significant medical condition that preclude participation at investigator criteria
• Allergy or hypersensitivity to salicylates
• Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments