Study in patients to investigate a new drug for treatment of psoriasis

• Research type

  Research Study

• Full title

  A randomized, subject-blind, investigator-blind, placebo-controlled, single dose, dose-escalating study evaluating the safety, pharmacokinetics and pharmacodynamics of UCB4940 in patients with mild to moderate psoriasis

• IRAS ID

  115470

• Contact name

  John Lambert

• Sponsor organisation

  UCB Celltech, UK Registered Branch of UCB Pharma SA

• Eudract number

  2012-002086-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The new medicine being tested in this study is a compound called UCB4940, it is hoped UCB4940 will be helpful in treating patients with psoriasis and other autoimmune diseases. This study will recruit patients with mild to moderate plaque-type psoriasis, males and females between the ages of 18 and 70 years. Psoriasis is an inflammatory disease of the skin. The most common form, plaque psoriasis, is commonly seen as red and white to silvery coloured scaly patches appearing on the surface of the skin. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. The main purpose of this study is to see how safe UCB4940 is and how well it is tolerated after dosing. The study will also investigate the pharmacokinetics (how well UCB4940 is taken up, metabolised [chemically broken down], distributed through the body and excreted) and the effect of single doses of UCB4940 on the clinical features of the plaque psoriasis. UCB4940 will be administered in increasing doses to find out possible dose limits for safety and tolerability. The effect of UCB4940 will be determined based on the assessment of skin samples of psoriasis plaques and on blood analysis. Blood tests may also be performed to assess the response of the body to UCB4940 (it may be tested if participants produced antibodies to the UCB4940). UCB4940 or a placebo will be administered as a single intravenous (into the vein) infusion. Vital signs, safety ECG measurements, safety laboratory assessments, adverse events (AEs) and concomitant medications will be monitored throughout the entire investigational period. Plasma samples for pharmacokinetic and pharmacodynamic (what the UCB4940 does to the body) analysis will be collected and the effect of UCB4940 on the plaque psoriasis will also be evaulated by various assesments, including skin biopsies.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0564

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion