SAD Safety, PK&PD of IV GSK2831781 in HV & patients with psoriasis

• Research type

  Research Study

• Full title

  A randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a IV dose of GSK2831781 in healthy volunteers and patients with plaque psoriasis

• IRAS ID

  150480

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@parexel.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2014-000312-33

• Duration of Study in the UK

  2 years, 4 months, 28 days

• Research summary

  The new medicine tested in this study is called GSK2831781. GSK is developing GSK2831781 to treat diseases of the immune system, including psoriasis.

  GSK2831781 is an antibody which removes certain types of immune cells marked by a substance called LAG-3. LAG-3 immune cells are present in certain diseases of the immune system and also when you have an infection. A drug decreasing these immune cells would be a new type of immunosuppressant.

  The main purpose of the study is to look at:
  • the effects/side-effects and the blood levels of GSK2831781 and how quickly the body gets rid of it
  • how the participants' genetics affect how GSK2831781 works

  A person's genetics may influence the working/availability of GSK2831781.

  The study is divided into Parts A and B. Separate groups will be included in each part of the study. A blood sample will be drawn for genetic (DNA) testing. If participants do not wish to consent to this sample, they may still take part in the main part of the study.

  Part A of the study will recruit healthy males, while Part B of the study will recruit males and females (of non-childbearing potential) with plaque psoriasis, all between the ages of 18 and 65 years (inclusive). Approximately 63 participants (31 in Part A, 32 in Part B) will take part in the study.

  A Purified Protein Derivative (PPD) test will used to assess if a person has been exposed to tuberculin protein.

  Safety assessments will be preformed and monitored throughout the study. Plasma samples to see what the body does to GSK2831781, how the body makes antibodies against GSK2831781, specific serum proteins, immune cell analysis, as well as skin biopsies, will be collected. Assessments of skin lesions will be made.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  14/LO/0528

• Date of REC Opinion

  15 Apr 2014

• REC opinion

  Favourable Opinion