Serono's US CLARITY trial starts enrolling

Swiss biotechnology group Serono has started recruitement for the Phase III USA-based CLAdRIbine Tablets in Treating MS OrallY Study (CLARITY), evlauating its oral drug candidate cladribine in patients with relapsing forms of multiple sclerosis.

This multinational study was successfully initiated in 2005, and will now expand to include 17 clinical trial sites in the USA. According to the firm, the study is one of the largest MS trials ever conducted, and enrollment is on track to be completed during the year.

The two-year, double-blind, placebo-controlled, 1,200-patient Phase III study is designed to assess clinical relapses, disability progression and magnetic resonance imaging brain activity. Previous clinical trials using cladribine administered by injection in MS patients showed reduction of new lesion development in the brain as seen on MRI scans as well as relapse reductions.