A clinical study to optimise the treatment with cobitolimod
Based on the encouraging results from earlier studies InDex has performed a phase IIb study to evaluate other doses and dose frequencies than investigated in previous studies with cobitolimod. The study objective was to identify the most efficacious dose and dose regimen for further development.
The CONDUCT study met the primary endpoint with an outstanding combination of efficacy and safety
The top line results were announced on August 27, 2019 demonstrating that the study met the primary endpoint of clinical remission, with a superior efficacy in patients receiving the highest dose of cobitolimod compared to placebo. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo.
The CONDUCT study in brief
CONDUCT was a randomised, double blind, placebo controlled study for evaluating cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. The study include 213 patients with left-sided moderate to severe active ulcerative colitis, divided into four treatment arms receiving cobitolimod and one arm receiving placebo. In addition to cobitolimod or placebo, all patients continued with their standard of care treatment. The patients were followed for a total of 10 weeks. For more details on the study please visit www.clinicaltrials.gov/show/NCT03178669
Professor Raja Atreya at the University of Erlangen-Nürnberg in Germany was the principle investigator of the CONDUCT study and Professor Walter Reinisch at the Medical University of Vienna was Medical Advisor in the study.
The study was conducted at approximately 90 sites in 12 different European countries: the Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Sweden and the Ukraine respectively.
CONDUCT is short for CObitolimod as Novel DNA-based Ulcerative Colitis Treatment