A clinical study to optimise the treatment with cobitolimod
Based on the encouraging results from earlier studies InDex is now performing a phase IIb study to evaluate other doses and dose frequencies than investigated in previous studies with cobitolimod. The goal of the study is to optimise the treatment and achieve substantially higher efficacy, while maintaining the compound’s excellent safety profile.
For more details on the study please visit www.clinicaltrials.gov/show/NCT03178669
The CONDUCT study in brief
CONDUCT is a randomised, double blind, placebo controlled study for evaluating cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. The study will include 215 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 will continue with their standard of care treatment. The patients will be followed for a total of 10 weeks. Top line results from the study are expected in the first half of 2019.
Professor Raja Atreya at the University of Erlangen-Nürnberg in Germany is the principle investigator of the CONDUCT study and Professor Walter Reinisch at the Medical University of Vienna is Medical Advisor in the study.
The study is being 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 approved by the Medical Products Agencies and Ethical Committees in all 12 countries and clinics are enrolling patients into the study.
CONDUCT is short for CObitolimod as Novel DNA-based Ulcerative Colitis Treatment