Study to Evaluate the Efficacy & Safety of LY2439821 Vs Placebo in Ps

• Research type

  Research Study

• Full title

  A Multicenter Study with a Randomized, Double-Blind,Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis.

• IRAS ID

  92399

• Contact name

  Christopher EM Griffiths

• Sponsor organisation

  Eli Lilly and Company Limited

• Eudract number

  2011-002970-22

• Clinicaltrials.gov Identifier

  NCT01474512

• 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 (a drug that looks like the study drug, but contains no medicine) in treating psoriasis. ?½ Is LY2439821safe and are any side effects associated with its use? Study I1F-MC-RHAZ (RHAZ) is an outpatient study examining the effect of LY2439821 versus placebo in patients with moderate-to-severe psoriasis during an initial 12 week Induction Dosing Period, followed by a Maintenance Dosing Period to Week 60, and a subsequent Long-Term Extension Period. During the Induction Dosing Period, the study will look at how effective LY2439821 is in treating plaque psoriasis. During the Maintenance Dosing Period, the study will evaluate the maintenance of response with continued treatment with LY2439821, the safety of treatment, how soon disease symptoms return following treatment withdrawal, and response to retreatment following relapse. In addition, longer-term efficacy and safety will be evaluated for up to a total of 5 years in the Long-Term Extension Period for patients who participate through the entire study. About 1296 participants will be taking part in the study for about 5 years.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0036

• Date of REC Opinion

  12 Apr 2012

• REC opinion

  Further Information Favourable Opinion