InDex and Parexel to Collaborate in Phase 2b CONDUCT Study of Kappaproct for UC

InDex and Parexel to Collaborate in Phase 2b CONDUCT Study of Kappaproct for UC
InDex Pharmaceuticals and the contract research organization (CRO) Parexel are partnering to manage the overseas Phase 2b CONDUCT dose optimization clinical trial of Kappaproct (cobitolimod) for the treatment of moderate to severe active ulcerative colitis (UC). Based on the contract between the companies, the first patient in the CONDUCT study will be enrolled during the second quarter of 2017, with topline data expected in late 2018. CONDUCT is a double-blind, placebo-controlled trial that will evaluate the safety and effectiveness of Kappaproct compared to a placebo in 215 patients with left-sided moderate to severe active UC.  Patients will be randomized to four treatment arms, either Kappaproct at different doses and dose frequencies or a placebo, with the aim of optimizing treatment. The goal is to compare Kappaproct’s safety and effectiveness with other drugs on the market and in late-stage clinical development, as well as demonstrating a substantially higher efficacy than seen in previous studies. All patients will also receive standard of care treatment. The trial will be conducted across 90 clinical sites in 12 countries: Hungary, Italy, Czech Republic, France, Germany, Romania, Russia, Poland,  Serbia, Spain, Sweden and Ukraine. Each country is undertaking the measures required to have the trial approved by its own regulators and ethics committees. InDex, a Swedish pharmaceutical company, said there will be no sites in the United States due to the high cost per patient. "We are very pleased to have Parexel as our partner for this important trial with cobitolimod, o
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