Sanofi, Regeneron Launch Dupilumab Phase 3 Study In Atopic Dermatitis

Sanofi and partner Regeneron Pharmaceuticals announced the launch of the Phase 3 study investigating dupilumab in moderate to severe atopic dermatitis (AD) with the dosing of the first patient.

Dupilumab is a fully-human monoclonal antibody (mAb) directed against the IL-4 receptor alpha subunit. The drug blocks signaling from both IL-4 and IL-13. These key cytokines have been shown to play a part in both the stimulation and maintenance of Type 2 helper T-cell immune response, which in turn, is considered to serve as a critical pathway in allergic inflammation, such as AD. In July, Regeneron reported positive results from a Phase 2B dose-ranging trial of dupilumab in AD, where all doses of the drug met the primary endpoint of greater improvement in disease severity from baseline versus placebo. The drug is also being jointly developed by Sanofi and Regeneron in asthma and chronic sinusitis with nasal polyposis.

Atopic dermatitis is a serious, chronic form of eczema and a systemic inflammatory disease driven by an allergic response of Type 2 helper T cells. Moderate to severe forms of the disease are characterized by itching, skin lesions, cutaneous dryness, and lichenification, among others. Secondary infections can be caused by extreme itching, scratching, and skin damage. AD is related to other inflammatory disorders like asthma.

The drug will be investigated in the double-blind, randomized, multi-national, placebo-controlled Phase 3 clinical program. Over the course of 16 weeks, LIBERTY AD CHRONOS will assess the drug’s efficacy in combination with topical corticosteroids in around 700 adult patients with moderate to severe AD whose disease is inadequately controlled by topical medications. The trial will also investigate long-term safety and efficacy of the drug for up to 52 weeks.

“Moderate-to-severe atopic dermatitis is a serious disease characterized by severe itching, sleep disturbances and widespread rash, and existing treatment options have limited efficacy. This Phase 3 program will evaluate if blocking IL-4 and IL-13, two key cytokines in the Th2 inflammatory pathway, may provide a potential new approach for this chronic, difficult-to-manage disease,” said Dr. Donald Y. M. Leung, member of the LIBERTY AD Clinical Trials Steering Committee and Head of the Division of Pediatric Allergy and Immunology at National Jewish Health in Denver, CO.