GSK systemic amyloidosis

• Research type

  Research Study

• Full title

  A single dose first in human study of GSK2398852 co-administered with GSK2315698 in patients with systemic amyloidosis.

• IRAS ID

  114884

• Contact name

  James Ritter

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2012-003345-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Serum amyloid P component(SAP) is a protein that normally circulates in blood; low amounts are also present in healthy tissues (e.g. elastic fibres and in the kidney). SAP is also present in deposits of abormal protein fibrils ("amyloid") that characterise amyloidisis. Systemic amyloidosis is a serious disease (expected survival 1-10 years in different forms) and current treatment is unsatisfactory. This present study involves two investigational drugs: an SAP depleter (GSK2315698) and an anti-SAP antibody (GSK2398852). Each does a different job but both are required to have the effect that we are investigating in this study: namely to see if these can remove amyloid deposits from organs in humans - an anti-SAP approach for the potential treatment of systemic amyloidosis. This will be the first time the anti SAP antibody has been given to humans. The SAP depleter has been given to small numbers (n=82)of healthy subjects and to patients with systemic amyloidosis (31 of whom have been treated with it for up to 2 years). Both drugs are being developed by GlaxoSmithKline, (the Sponsor, a pharmaceutical company based in the UK) and this study is being carried out on behalf of the Sponsor by Quintiles. The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) various single intravenous doses of the anti-SAP antibody when given with the SAP depleter in patients with systemic amyloidosis. We will also be looking for evidence that the anti-SAP approach leads to removal of amyloid in affected organs.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0630

• Date of REC Opinion

  19 Nov 2012

• REC opinion

  Favourable Opinion