The Clinical Study CONDUCT

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 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 are followed for a total of 10 weeks. The last patient was enrolled in the study on June 26, 2019. 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.

 

Implementation

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.

 

Status

The last patient was enrolled in the CONDUCT study on June 26, 2019. 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.

 

CONDUCT is short for CObitolimod as Novel DNA-based Ulcerative Colitis Treatment