Efficacy & Safety/Tolerability of Subcutaneous SCH900222/MK-3222

• Research type

  Research Study

• Full title

  A 64-Week, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous SCH 900222/MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

• IRAS ID

  114271

• Contact name

  Christopher Griffiths

• Sponsor organisation

  Sun Pharma Global FZE

• Eudract number

  2012-002255-42

• Duration of Study in the UK

  4 years, 11 months, 0 days

• Research summary

  Psoriasis is a chronic inflammatory skin disease that affects 2% to 3% of the global population. The most common form affecting participants, is characterised by recurrent episodes of sharply demarcated, erythematous (redness of the skin), scaly plaques of variable size and confluence. Psoriasis significantly affects the physical and emotional well-being of patients, and may lead to substantial burden in terms of disability or psychosocial stigmatisation.

  This Phase 3 pivotal base study will evaluate the efficacy and safety/tolerability of MK-3222 in participants with moderate-to-severe chronic plaque psoriasis and the long-term safety extension study will evaluate the long-term safety and maintenance of effect.

  MK-3222, is a humanised antibody that is under investigation for patients with moderate-to-severe chronic plaque psoriasis, and data from early phase clinical trials suggest that MK-3222 improves the signs and symptoms of psoriasis.

  Primary Objectives of the study are:
  The purpose of the Base Study is to:
  • test the safety/tolerability of the research study drug, SCH900222/MK 3222 which will be called MK-3222 compared to placebo
  • test if MK-3222 is effective for treating moderate to severe chronic plaque psoriasis compared to placebo

  The purpose of the Extension Study is to:
  • test the long-term safety/tolerability of MK-3222

  Participants will receive MK-3222 or MK-3222 matching placebo (at Weeks 0 and 4 (n=150) subcutaneously, just under the skin, with pre-filled syringes.

  This is a research study to test a drug that has not yet been approved for sale in the UK, and will not be available on prescription in the UK.

  Including both the Base Study and the Extension Study, the entire study will last about 280 weeks (approximately 5 years and 5 months). In this case, the Base Study will last about 68 weeks (approximately 1 year and 4 months), which includes a screening period of up to 4 weeks and a treatment period of approximately 64 weeks. The Extension Study will last for about 212 weeks (approximately 4 years and 1 month); this part of the study will include a treatment period of 192 weeks, and then continue in a 20 week follow-up period.

  About 750 people will be randomised in the Base Study. Participants who take part in the Base Study only will do so for 88 weeks (approximately 1 year and 9 months), which includes a screening period of up to 4 weeks, a treatment period of approximately 64 weeks, and a 20 week follow-up period.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0814

• Date of REC Opinion

  10 Jan 2013

• REC opinion

  Further Information Favourable Opinion