P05495

• Research type

  Research Study

• Full title

  Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous SCH 900222 in Subjects with Moderate-to-Severe Chronic Plaque Psoriasis

• IRAS ID

  49370

• Contact name

  Jonathan Barker

• Sponsor organisation

  Schering-Plough Research Institute, a Division of Schering Corporation

• Eudract number

  2009-017272-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a randomised double-blind placebo controlled study looking at the safety and efficacy of different doses of SCH 900222 versus placebo in patients with moderate to severe chronic plaque psoriasis. The study consists of 19 study visits over approximately 18 months. Participants will be asked to attend for the following visits at the hospital: Screening, Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 20, 28, 34, 40, 46, 52, 56, 60, 64, 68 and 72After a screening/washout period of up to 4 weeks, eligible Patients will be randomised in a 1:2:2:2:1 ratio to one of four SCH 900222 treatment groups or placebo at Weeks 0 and 4. They will receive 3 sc injections per visit in order to maintain the blind. Depending on the improvement in psoriasis after 16 weeks, participants will be go onto a maintenance schedule and be given 1 of 3 possible doses; a lower dose, the same dose or a higher dose of SCH 900222 at weeks 16, 28, 40, and 52. Responders at week 16 will continue to receive 3 sc injections per visit in Part 2 and non-responders will receive 2 sc injections per visit. At Week 28 non-responding participants will be discontinued from the trial. All participants will be asked to continue to attend the clinic for follow up evaluations every 4 weeks for a further 20 weeks following their last injection. Study evaluations will include medical and drug history, ECG, TB testing Chest X-ray, blood tests, pregnancy tests, skin evaluations and questionnaires.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/62

• Date of REC Opinion

  28 Oct 2010

• REC opinion

  Further Information Favourable Opinion