S1P1 agonist in severe chronic plaque psoriasis

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of two doses of ACT-128800, an oral S1P1 receptor agonist, administered up to twenty-eight weeks in patients with moderate to severe chronic plaque psoriasis

• IRAS ID

  54910

• Contact name

  Anthony Bewley

• Sponsor organisation

  Actelion Pharmaceuticals Ltd

• Eudract number

  2010-019283-36

• Research summary

  This clinical research study will be performed in approximately 60 hospitals in 10 countries in Europe with a total of approximately 320 patients. Men and women with moderate to severe psoriasis will be included in this study. This study is divided into two treatment periods: The induction period which consists of the initial 16 weeks of treatment. The maintenance period which consists of 12 additional weeks of treatment. Only patients who have received some improvement of their psoriasis will enter the maintenance period. If patients show no improvement during the induction period then they will discontinue the study after 16 weeks. During the induction period, 80% of the patients will be treated with one of the two doses of study drug ACT-128800, and 20% of patients will receive placebo. From those patients who will receive study drug ACT-128800, half will receive a 20 mg daily dose and half will receive a 40 mg daily dose. The criteria to meet entry into the maintenance period is based on a Doctor’s assessment of the psoriasis .The doctor will assess severity of the Psoriasis by commonly used scales: Psoriasis Area and Severity Index (PASI) and Psoriasis Global Assessment (PGA). During the maintenance period, half of the patients who received the 20 mg daily dose of ACT-128800 for the initial 16 weeks of the study will continue receiving the same daily dose of ACT-128800, whereas the other half of the patients will receive placebo. Similarly, half of the patients who received the 40 mg daily dose of ACT-128800 for the initial 16 weeks will continue receiving the same daily dose of ACT-128800 whereas the other half of the patients will receive placebo. All of the patients who received placebo for the initial 16 weeks of the study will continue receiving placebo in the maintenance period. The maximum length of the study will be 37 weeks.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/62

• Date of REC Opinion

  7 Sep 2010

• REC opinion

  Further Information Favourable Opinion