Study with secukinumab in palmoplantar psoriasis

  • Research type

    Research Study

  • Full title

    A randomised, doubleblind, placebocontrolled, multicentre study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300mg s.c. and to assess safety, tolerability and longterm efficacy up to 132 weeks in subjects with moderate to severe palmoplantar psoriasis.

  • IRAS ID

    126074

  • Contact name

    Catherine Hatchard

  • Contact email

    Catherine.hatchard@novartis.com

  • Sponsor organisation

    Novartis Pharmaceuticals

  • Eudract number

    2012-005412-25

  • ISRCTN Number

    n/a

  • Research summary

    Psoriasis is a long lasting disease that appears on the skin. It results in patches of thick, red, raised skin covered with silvery white buildup of dead skin cells called scales. These patches, which are referred to as plaques, may itch or feel
    sore. They can occur on any part of the body, including the palms and soles. The cause of psoriasis is not fully understood. It is believed that psoriasis occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.
    In this study we are using a drug called secukinumab, this is a new class of protein based drug ("biologics") which target and neutralise specific chemical messages involved in the disordered immune processes of psoriasis.
    In this study suitable patients with palmoplantar psoriasis will receive secukinumab or placebo for approximately 18 months, during which time their palmoplantar psoriasis and safety will be regularly assessed. For the group allocated placebo, after 4 months if they are showing no signs of improvement they will also be allocated secukinumab. The study is looking to recruit 201 patients globally with 7 patients to be recruited from the UK.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    13/LO/0665

  • Date of REC Opinion

    27 Jun 2013

  • REC opinion

    Further Information Favourable Opinion