The Efficacy & Safety of LY2439821, Etanercept Vs Placebo in Ps

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis

• IRAS ID

  100185

• Contact name

  Christopher Griffiths

• Sponsor organisation

  Eli Lilly and Company Limited

• Eudract number

  2011-004350-26

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Plaque psoriasis (psoriasis) is a skin condition that causes scaly patches (lesions) on the skin. These lesions most often affect the elbows, knees, and scalp, but may occur on any part of the body. Sometimes psoriasis causes pain, itching, and cracking of the skin. This study will investigate LY2439821, an investigational new drug. The primary purpose of the study is to determine: ?½ How LY2439821 compares to placebo as treatment for your psoriasis. ?½ How LY2439821 compares to etanercept as treatment for your psoriasis. ?½ Is LY2439821safe and are any side effects associated with it Study I1F-MC-RHBA is an outpatient study examining the effect of LY2439821 compared to etanercept and versus placebo in patients with moderate-to-severe psoriasis. During an initial 12-week Induction Dosing Period, the study will look at the effectiveness of LY2439821 in treating patients with plaque psoriasis compared to etanercept and to placebo. Following the initial dosing period, a Maintenance Dosing Period (thru Week 60), will evaluate the maintenance of response/remission with continued treatment with LY2439821, how soon disease symptoms return following treatment withdrawal, and response to re-treatment following relapse. In addition, longer-term efficacy and safety will be evaluated for up to a total of 5 years in a Long-Term Extension Period for patients who participate through the entire study. About 1225 participants will be taking part in the study for approximately 5 years.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0089

• Date of REC Opinion

  6 Aug 2012

• REC opinion

  Further Information Favourable Opinion