Sanofi and Regeneron announced the premature termination of Phase 3 CUPID STUDY B trial of Dupixent (dupilumab), due to futility based on a pre-specified interim analysis.

The Phase 3 study assessed Dupixent in patients with chronic spontaneous urticaria (CSU) who were refractory to asthma treatment omalizumab.

In the interim analysis, the treatment showed positive results in reducing itch and hives (primary endpoints) but did not show statistical significance for the primary endpoints.

The drug’s safety data were generally consistent with the known safety profile of Dupixent in its approved indications.

Sanofi research and development global head John Reed said: “Although we are disappointed in these latest results, this interim analysis contributes to furthering our understanding of the role of type 2 inflammation in this subset of CSU patients who are refractory to all other approved therapies.

“Based on the results seen in our first Phase 3 trial, and the numerical trends observed in this interim analysis, we remain committed to advancing Dupixent as an option for patients suffering from CSU who are uncontrolled on anti-histamines. We look forward to discussing next steps with regulators.”

Dupixent is a fully human monoclonal antibody that works to inhibit the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, but is not an immunosuppressant.

The IL-4 and IL-13 interleukins are believed to play important role in atopic dermatitis, asthma and chronic rinusinusitis with nasal polyps (CRSwNP).

In the trial, patients who were refractory to omalizumab treatment and uncontrolled on antihistamines were given Dupixent plus standard of care, versus standard of care alone.

The drug is currently approved in more than 60 countries including the US, Europe, Japan and other countries, to treat atopic dermatitis, asthma or CRSwNP in different populations.

Phase 3 CUPID STUDY B is part of the LIBERTY-CUPID pivotal programme, which was launched in 2020, following the initial CUPID STUDY A study.

CUPID STUDY A assessed patients who were biologic-naïve, who were not previously treated with omalizumab, and has met the primary and all key secondary endpoints.

Furthermore, Sanofi and Regeneron are advancing a broad clinical development programme to evaluate Dupixent in diseases with significant unmet needs.