Date: 2012-03-06
Type of information:
phase: 3
Announcement: initiation of the trial
Company: InDex Pharmaceuticals (Sweden)
Product: Kappaproct®
Action mechanism: Kappaproct® (DIMS0150) is a modified single strand DNA-based synthetic oligodeoxyribonucleotide of 19 bases in length. The drug functions as an immunomodulatory agent by targeting the Toll-like receptor 9 (TLR9) present in immune cells residing in high abundance on mucosal surfaces, such as colonic and nasal mucosa. The mucosa of the colon and rectum of patients with ulcerative colitis contains active immune cells, which produce damage to the tissue. The activation of these cells by Kappaproct® results in the systemic release of specific cytokines (e.g., IL-10 and type I interferons) and chemokines which are believed to be important factors for the clinical effect of Kappaproct. Ex vivo experiments with Kappaproct have demonstrated that the drug has the ability to enhance the steroid sensitivity of peripheral blood mononuclear cells obtained from steroid refractory UC patients. Thus, the desired effect is to restore steroid sensitivity in steroid refractory patients such that they may benefit from the anti-inflammatory actions of the steroid and ultimately become steroid free.
Disease: chronic active ulcerative colitis
Therapeutic area: Inflammatory diseases - Autoimmune diseases
Country: Czech Republic, Germany, Hungary, Italy, Poland, UK
Trial details: COLLECT is a double-blind, placebo-controlled phase III study, in which 120 treatment refractory UC patients are being randomized in a 2:1 ratio of receiving either Kappaproct or placebo intracolonically. Kappaproct® or placebo will be administered as an add-on treatment, allowing all study patients to remain on concomitant medication throughout the study. The study will be conducted at 36 sites in six European countries. 120 eligible patients will be randomly assigned in a 2:1 allocation to receive two rectal doses of Kappaproct at 30 mg, or placebo, at week 0 and 4. The primary endpoint is the induction of clinical remission at week 12 and patients will be continuously followed for efficacy and safety until 12 months after the first dose. (NCT01493960)
Latest
news: * On March 6, 2012, InDex Pharmaceuticals has announced the start of the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety of Kappaproct® for the treatment of chronic active ulcerative colitis (UC) patients not responding to available therapy. The primary endpoint of the COLLECT study is induction of clinical remission in these severe UC patients, who have failed all other medical treatments and have been elected for colectomy. Preliminary results are expected for Q1, 2014.
