Novartis’ Phase IIIb CLEAR trial of psoriasis drug Cosentyx meets endpoints

15th December 2014 (Last Updated December 15th, 2014 18:30)

Swiss drug-maker Novartis has reported positive results from its Phase IIIb CLEAR trial of Cosentyx (secukinumab, formerly known as AIN457) in patients with psoriasis.

Swiss drug-maker Novartis has reported positive results from its Phase IIIb CLEAR trial of Cosentyx (secukinumab, formerly known as AIN457) in patients with psoriasis.

The Phase IIIb trial of Cosentyx showed superiority to Stelara (ustekinumab) and met its primary endpoint of achieving PASI 90, which represents clear or almost clear skin at week 16 for these patients.

Cosentyx works by inhibiting the action of IL-17A, a protein found in high concentrations in skin affected by psoriasis.

The company said that the trial also met the secondary endpoint of achieving PASI 75 at week four and the safety results were consistent with previously reported Phase III clinical trials for Cosentyx.

"Cosentyx works by inhibiting the action of IL-17A, a protein found in high concentrations in skin affected by psoriasis."

CLEAR is the second head-to-head study for Cosentyx following the Phase III FIXTURE study that showed Cosentyx was superior to Enbrel (etanercept), a current standard-of-care, in clearing psoriasis skin with a comparable safety profile.

The 52-week, multicentre, randomised, double-blind trial compared the efficacy, long-term safety and tolerability of Cosentyx versus ustekinumab, in patients with moderate-to-severe plaque psoriasis.

Novartis Pharmaceuticals Development global head Vasant Narasimhan said: "We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors.

"Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx."

The trial included 679 moderate-to-severe plaque psoriasis patients and will be submitted for presentation at an international medical congress in 2015.

The results follow a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending Cosentyx as first-line systemic therapy to treat moderate-to-severe plaque psoriasis in adult patients.

Currently in Europe, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy.

Additionally, the FDA Advisory Committee voted unanimously for the approval of Cosentyx in the US.