Novartis Initiates Phase 3 Study Of Secukinumab VS Stelara

Novartis announced that it has begun patient enrollment of a Phase IIIB head to head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis.

The new study entitled CLEAR follows the positive Phase III FIXTURE study results showing secukinumab superiority to Enbrel (etanercept) in clearing patients’ affected skin areas.

Tim Wright, Global Head of Development at Novartis Pharmaceuticals, said, “We are pleased to announce the start of CLEAR, our global phase IIIb head-to-head psoriasis study of secukinumab versus Stelara at the 2014 AAD annual meeting, which will provide further evidence regarding the benefit IL-17A inhibitor secukinumab brings to patients. We initiated this study following the positive results from the phase III FIXTURE study, which showed secukinumab was significantly superior to Enbrel in clearing skin, and we look forward to presenting additional new phase III data from our specialty dermatology portfolio at AAD.”

Plaque psoriasis affects nearly 3% of the world’s population or roughly more than 125 million people around the world. One third of these patients suffer from the disease’s moderate to severe form. About 40% to 50% of patients express dissatisfaction with current therapies and indicate an unmet clinical need for more fast acting and long relief therapies.

Secukinumab is a fully human monoclonal antibody that selectively targets, binds to, and neutralizes interleukin(IL)-17A. IL-17A plays a major role as a central cytokine in the development of psoriasis and in driving the body’s autoimmune response in disorders such as moderate to severe plaque psoriasis. The cytokine is usually a preferred target for experimental therapies.

A total of twenty-five secukinumab abstracts from the Novartis specialty dermatology portfolio including two pivotal phase III convenience studies will be presented for the first time at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) to be held in Denver, Colorado, USA from 21-25 March 2014. A new pivotal Phase III study for secukinumab will also be revealed at the dermatology congress.