Janssen reports positive results from two Phase III trials of guselkumab in plaque psoriasis

5th March 2017 (Last Updated March 5th, 2017 18:30)

Janssen Research & Development has reported positive results from two Phase III clinical trials of guselkumab for the treatment of adults with moderate-to-severe plaque psoriasis.

Janssen Research & Development has reported positive results from two Phase III clinical trials of guselkumab for the treatment of adults with moderate-to-severe plaque psoriasis.

Guselkumab is a human monoclonal antibody designed to target the interleukin protein.

The VOYAGE 2 trial data indicated that guselkumab significantly improved measures of disease activity such as skin clearance in comparison to placebo, and that greater improvements were observed when compared with the anti-tumour necrosis factor (TNF) alpha treatment Humira (adalimumab).

The results from the NAVIGATE trial found that patients who had an inadequate response after the anti-interleukin (IL)-12/23 monoclonal antibody (mAb) STELARA (ustekinumab) treatment and later switched to guselkumab showed significantly better improvements in skin clearance.

"Data from the Phase III VOYAGE 2 and NAVIGATE studies continue to demonstrate the potential that guselkumab may offer patients and physicians."

Janssen immunology development head Newman Yeilding said: “Data from the Phase III VOYAGE 2 and NAVIGATE studies continue to demonstrate the potential that guselkumab may offer patients and physicians, and we are committed to working with health authorities around the world on our current and future applications.”

The VOYAGE 2 is a randomised, double-blind, placebo-controlled and active-comparator controlled Phase III trial conducted to evaluate the safety and efficacy of guselkumab compared with placebo and adalimumab, as well as the guselkumab maintenance therapy compared with therapy withdrawal.

The randomised, double-blind, multicentre Phase III NAVIGATE trial is designed to evaluate the efficacy and safety of guselkumab compared with ustekinumab in patients who had an inadequate response to treatment with ustekinumab.

Ustekinumab is indicated to treat moderate-to-severe plaque psoriasis in adults who either failed to respond to, have a contraindication to, or are intolerant to other systemic therapies.

The firm intends to further study the safety and efficacy of guselkumab in a Phase III trial to treat active psoriatic arthritis.