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news.CombinatoRx has completed patient enrollment in Comet-1, the company's Phase IIb clinical trial to evaluate the safety and efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis.
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This clinical trial is a multi-center, randomized, double-blind, placebo-controlled Phase IIb study where 279 subjects have been enrolled. The trial is a standard flare design where patients with active disease must demonstrate an increase in knee pain upon withdrawal of their Nsaid/Coxib therapy to be eligible.
In the study, patients are randomized to three different doses of CRx-102 (2.7mg prednisolone and 360mg, 180mg or 90mg of dipyridamole), 2.7mg of prednisolone alone or placebo. Patients will be dosed for a total of 14 weeks (98 days) including an initial two-week dipyridamole titration Phase.
The primary endpoint of this study to assess the efficacy of CRx-102 compared to placebo is the change in Womac pain score calculated from baseline to day 98. Patients who complete the 14-week core study are eligible to participate in a one-year extension study to investigate the long-term safety and durability of response for CRx-102.
CRx-102 is an oral synergistic combination drug candidate in development for immuno-inflammatory diseases, including osteoarthritis and rheumatoid arthritis.