Novartis Starts Secukinumab Vs Stelara Phase IIIb Head-to-head Psoriasis Study

By RTT News, March 21, 2014, 02:45:00 AM EDT

(RTTNews.com) - Novartis ( NVS ) announced Friday that a new phase IIIb head-to-head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara or ustekinumab in moderate-to-severe plaque psoriasis has started patient enrollment.

The company stated that a total of twenty-five secukinumab abstracts, including two pivotal phase III convenience studies to be presented for the first time, will be unveiled at the 72nd Annual Meeting of the American Academy of Dermatology or AAD, taking place in Denver, Colorado, USA from 21-25 March 2014.

"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," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals.

CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab), the new 52-week, multicenter, randomized, double-blind study, is the second head-to-head phase III study initiated with secukinumab, and will compare the long-term safety, tolerability and efficacy of secukinumab versus Stelara, a current standard-of-care therapy, in patients with moderate-to-severe plaque psoriasis.

The target enrollment for this global phase IIIb study is approximately 640 patients with sites in 25 countries across North America, Europe, Asia and Australia.

The primary endpoint measured at Week 16 is at least 90% reduction in the severity of psoriasis symptoms (redness, thickness and scaling) and the extent of skin affected by the disease, known as Psoriasis Area and Severity Index (PASI) 90. PASI 90 is considered the best evidence of efficacy and is therefore a more robust measure of the extent of skin clearance compared to the standard efficacy measures used in most psoriasis clinical studies.

The CLEAR study follows the pivotal phase III head-to-head FIXTURE study, which showed secukinumab was significantly superior to Enbrel in clearing skin. Enbrel is a current standard-of-care anti-TNF-alpha medication approved to treat moderate-to-severe plaque psoriasis, and results from the FIXTURE study were first announced in October 2013.

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Novartis Starts Secukinumab Vs Stelara Phase IIIb Head-to-head Psoriasis Study