CONDUCT was a randomized, double blind, placebo-controlled study to evaluate cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo, in patients with left-sided moderate to severe active ulcerative colitis. The study objective was to identify the dose regimen for further development. The 213 patients were divided into four treatment arms receiving cobitolimod and one arm receiving placebo. Three different dose strengths of cobitolimod were investigated: 30 mg, 125 mg and 250 mg given twice, at baseline and at week 3. 125 mg given four times, at baseline and each week until week 3, was also investigated. In addition to cobitolimod or placebo, all patients continued with their standard of care treatment.
The primary endpoint of the study was induction of clinical remission at week 6 defined by modified Mayo sub scores, with a rectal bleeding score of 0, a stool frequency score of 0 or 1 and an endoscopy score of 0 or 1. The study was conducted at 91 sites in 12 different European countries: the Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Sweden and the Ukraine respectively. For more details on the study please visit http://www.clinicaltrials.gov/show/NCT03178669.