Clinical Trials

monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A). Research shows that IL-17A plays a key role in driving the body\'s autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies. Regulatory submissions for secukinumab in the EU and US were completed in 2013. In January 2015, Cosentyx® (at a dose of 300 mg) became the first and only IL-17A inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients, and in the US as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In addition to the EU and the US, Cosentyx® has been approved in Switzerland, Chile, Australia, Canada and Singapore for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Cosentyx® is also in Phase III development for PsA and ankylosing spondylitis; global regulatory applications are planned for 2015.

 

 

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. The study 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 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.

Twenty-four countries across North America, Europe, Asia and Australia participated in the study, with enrollment reaching 679 patients in record time.

 

* On March 20, 2015, Novartis announced  results from the CLEAR study demonstrating that Cosentyx® (secukinumab) is significantly superior to Stelara® (ustekinumab), a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, USA. In this Phase IIIb study, Cosentyx® met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index (PASI) 90 response, known as clear to almost clear skin, at Week 16 (79.0% vs. 57.6%, P<0.0001). PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin (PASI 100) at Week 16 was achieved by significantly more patients treated with Cosentyx® than those receiving Stelara (44.3% vs. 28.4%, P<0.0001). In addition, Cosentyx® demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx® patients achieving PASI 75 as early as Week 4 compared to Stelara (50.0% vs. 20.6%, P<0.0001)[1]. The safety profile of Cosentyx® was comparable to Stelara® and consistent with previously reported Phase III clinical trials for Cosentyx®.

* On March 21, 2014, Novartis has announced that a new phase IIIb head-to-head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara® (ustekinumab) in moderate-to-severe plaque psoriasis has started patient enrollment. The CLEAR study is a new head-to-head study initiated following positive phase III FIXTURE study results showing secukinumab superiority to Enbrel® (etanercept) in clearing patients\' skin. 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.

-An analysis from the FIXTURE study showing secukinumab fast onset of efficacy compared to Enbrel in moderate-to-severe plaque psoriasis

- Primary efficacy and safety data of secukinumab in chronic plaque-type psoriasis patients from the first secukinumab study in pre-filled syringes (FEATURE)

- Primary efficacy and safety data in psoriasis patients with the secukinumab autoinjector/pen (JUNCTURE)

- An analysis of secukinumab pre-filled syringes and patient satisfaction through the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE study

- An analysis of secukinumab autoinjector and patient satisfaction through the SIAQ in the JUNCTURE study

Secukinumab is the first therapy selectively targeting IL-17A with phase III results. Regulatory submissions for secukinumab in the EU and US were completed in 2013, based on the largest phase III program in moderate-to-severe plaque psoriasis completed to date, which involved more than 3,300 patients in over 35 countries.