The phase IIIb CLEAR study for Secukinumab ( Cosentyx ) has demonstrated superiority to Ustekinumab ( Stelara ) and met its primary endpoint of achieving PASI 90, which represents clear or almost clear skin at week 16 for psoriasis patients.
The study also met the secondary endpoint of achieving PASI 75 at week 4.
Safety results were consistent with previously reported phase III clinical trials for Secukinumab.
The CLEAR study is the second head-to-head study for Secukinumab versus established psoriasis biologic treatments. It follows on from the phase III FIXTURE study, which showed that Secukinumab was superior to Etanercept ( Enbrel ), a current standard-of-care, in clearing psoriasis skin with a comparable safety profile.
Achieving clear skin is the ultimate aim of psoriasis treatment for patients. Data from the Secukinumab clinical trial program has also shown a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life.
Additionally, 50% of psoriasis patients are not content with current therapies, including biologic treatments.
The study involved 679 moderate-to-severe plaque psoriasis patients.
Topline results follow a positive CHMP opinion for Cosentyx as a first-line systemic treatment for patients with moderate-to-severe psoriasis. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies ( anti-TNFs ) and Ustekinumab are recommended for second-line systemic therapy in Europe.
In addition, the FDA Advisory Committee voted unanimously for the approval of Cosentyx in the US.
Secukinumab is a human monoclonal antibody that selectively neutralizes IL-17A, a protein that is found in high concentrations in skin affected by psoriasis.
CLEAR ( Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab ), a 52-week, multicenter, randomized, double-blind study, has compared the efficacy, long-term safety and tolerability of Secukinumab versus Ustekinumab, in patients with moderate-to-severe plaque psoriasis.
Twenty-four countries across North America, Europe, Asia and Australia1 participated in the study, with enrollment reaching 679 patients.
The primary endpoint measured at Week 16 is at least a 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 a more robust measure of the extent of skin clearance compared to the standard efficacy measures used in most psoriasis clinical studies.
Additionally the secondary endpoint measured at week 4 is at least a 75% reduction in the severity of psoriasis symptoms ( PASI 75 ). ( Xagena )