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Setback: Sanofi to halt Dupixent Phase 3 trial
Paris: Sanofi has recently announced that the Phase 3 trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis.Although positive numerical trends in reducing itch and hives were observed, the results from the interim analysis did...
Paris: Sanofi has recently announced that the Phase 3 trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis.
Although positive numerical trends in reducing itch and hives were observed, the results from the interim analysis did not demonstrate statistical significance for the primary endpoints. The analysis was conducted by an independent interim analysis review committee. In the trial, patients who were refractory to omalizumab treatment and uncontrolled on antihistamines received Dupixent plus standard of care compared to standard of care alone for 24 weeks. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.
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