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Textrainbow
Today, Regeneron and Sanofi announced that the Phase 3 trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) will be based on a prespecified interim analysis.
Dupixent did not achieve statistical significance in an interim analysis conducted by an independent review committee, despite improvements in the key endpoints observed in the trial
A previously reported phase 3 trial evaluating different groups of biologic-naïve (i.
CSU is a chronic inflammatory skin disease characterized by the sudden appearance of hives on the skin or swelling deep beneath the skin
The companies said they plan to use Dupixent for CSU patients with uncontrolled antihistamines and are evaluating next steps
Dupixent was first approved by the U.
Reference source: Regeneron, Sanofi To Stop Dupixent Phase 3 Trial In Chronic Spontaneous Urticaria Due To Futility