12:00 AM
Jul 01, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Omalizumab: Phase III data

The double-blind, international Phase III GLACIAL trial in 335 patients ages 12-75 with moderate to severe refractory CIU showed that 300 mg subcutaneous omalizumab given every 4 weeks for 24 weeks as an add-on to antihistamine therapy met the primary safety endpoint with a similar incidence and severity of adverse events between omalizumab and placebo. Seven patients experienced serious adverse events in the omalizumab arm compared to 3 patients in the placebo arm. No deaths were reported.

Omalizumab also met the "key" efficacy endpoint of reducing mean weekly ISS score from baseline to week 12 vs. placebo (8.6 points vs. 4...

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