Swiss drug maker Novartis has started enrolling patients in a new Phase IIIb head-to-head trial of IL-17A inhibitor secukinumab (AIN457) versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis.
The new 52-week, multicentre, randomised, double-blind Phase IIIb trial is also called CLEAR (‘Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab’).
Novartis Pharmaceuticals global head of development Tim Wright said: "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."
CLEAR is the second head-to-head Phase III trial started 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.
Around 640 patients are expected to be enrolled in the Phase IIIb trial, which will be carried out at sites in 25 countries across North America, Europe, Asia and Australia.
The primary endpoint of the trial measured at Week 16 is at least 90% reduction in the severity of psoriasis symptoms and the extent of skin affected by the disease, known as Psoriasis Area and Severity Index (PASI) 90.
Compared with standard efficacy measures used in most psoriasis clinical studies, PASI 90 is claimed to be the best evidence of efficacy and is therefore a more robust measure of the extent of skin clearance.
The CLEAR trial follows a major Phase III head-to-head FIXTURE study, which showed secukinumab was significantly superior to Enbrel in clearing skin.
The company said that a total of 25 secukinumab abstracts from its specialty dermatology portfolio will be presented at the 72nd Annual Meeting of the American Academy of Dermatology (AAD), taking place in Denver, Colorado, US, from 21-25 March 2014.
Around 3% of the world’s population, or more than 125 million people, are affected by plaque psoriasis, with more than one third of these suffering from its moderate-to-severe form.
The company said that between 40%-50% of patients are dissatisfied with their current psoriasis therapies, indicating an unmet need for convenient therapies that act faster and longer to relieve the debilitating symptoms.
Image: A person’s arm covered with plaque psoriasis. Photo: courtesy of Methoxyroxy.