Regeneron Pharmaceuticals, Inc. (REGN), and French drug maker Sanofi (SNYNF,SNY) announced Friday that they will stop an ongoing Phase 3 trial (CUPID STUDY B), evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria or CSU, due to futility, based on a pre-specified interim analysis.
In the trial, Dupixent did not reach statistical significance in interim analysis conducted by an independent review committee despite numeric improvements observed across key endpoints.
The companies said they plan to advance Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps.
CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin.
The trial, which assessed Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive numerical trends in reducing itch and hives, the primary endpoints.
The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.
The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy.
The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve (i.e., not previously treated with omalizumab), met its primary and all key secondary endpoints at 24 weeks. The trial showed that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.
The potential use of Dupixent in CSU, EoE, PN, CindU, and hand and foot atopic dermatitis are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
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