STATURE study

• Research type

  Research Study

• Full title

  A randomised, double-blind, double-dummy, multicentre study to assess the safety, tolerability and long-term efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in subjects with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

• IRAS ID

  87795

• Contact name

  James Warburton

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2011-002510-36

• ISRCTN Number

  na

• Research summary

  Psoriasis is a common skin condition affecting 2-3% of the population of the United Kingdom and Ireland. The cause of psoriasis is not fully known however there is significant evidence demonstrating a disorder of the immune system which causes new skin cells to be produced faster than normal. Skin cells usually take about 21-28 days to replace themselves; in psoriasis this process is greatly accelerated, and skin cells can be replaced every 2-6 days. This results in an accumulation of skin cells on the surface of the skin, in the form of a psoriatic plaque (white scaly area). There are various treatments that are used for Psoriasis ranging from topical creams (applied directly to the skin), phototherapy (treatment with ultraviolet light), systemic treatment (oral tablets) to biological treatment (injections given for those patients who do not respond to any other treatments listed above). Biologics are protein based drugs which target and neutralise specific chemical messages involved in disordered immune processes of psoriasis. Sekukinumab is a new class of biologic, and is an antibody directed against one of the chemical messages that is implicated in psoriasis, psoriatic arthritis, and rheumatoid arthritis. This study is designed for patients who are partial responders (defined as between 50 and 75% reduction in their PASI scores) to secukinumab in the CAIN457A2304 study and will discontinue treatment in that study. These patients will be offered the opportunity to enter this new study and receive secukinumab at a higher dose by intravenous infusion or subcutaneous injection in a double-dummy blind regimen for the first four weeks of the study. Thereafter they will receive the open-label higher dose (300mg) subcutaneously every four weeks until week 36. Patients will be followed up for 12 weeks after their last dose.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0450

• Date of REC Opinion

  15 Nov 2011

• REC opinion

  Favourable Opinion