Effects and safety of anti-SAP therapy in patients with amyloidosis;v1
Research type
Research Study
Full title
A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis (HMR code: 16-501)
IRAS ID
208494
Contact name
Ashutosh Wechalekar
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-000276-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Anti-SAP treatment is an experimental treatment for systemic amyloidosis (SA). SA is caused by abnormal proteins clumping together; forming ‘amyloid deposits’ in body organs, including the heart – the heart muscle stiffens, and can’t pump blood around the body efficiently. Existing medicines can help manage the symptoms, but can’t remove the deposits.\n\nAnti-SAP treatment targets a substance in amyloid deposits called serum amyloid P component (SAP). The treatment combines GSK2315698 (CPHPC), which removes SAP from the bloodstream, and GSK2398852, a monoclonal antibody against SAP (anti-SAP mAb), which attaches to SAP in amyloid deposits and directs the body’s immune system to clear them. \n\nTo see whether anti-SAP treatment removes amyloid deposits, we’ll use 3 types of scan to take pictures of the heart. Some of the scans use a tracer labelled with radioactivity. We’ll test whether anti-SAP treatment improves heart function and has any side effects, how quickly the body gets rid of it, and whether it can be given with chemotherapy. We’ll also do skin biopsies to investigate a rash that’s been reported in a previous study.\n\nFirst, we’ll recruit 20 patients with SA, aged 18–80 years. Later, we’ll test the treatment in 10 SA patients receiving chemotherapy. Participants will have monthly courses of anti-SAP treatment, for up to 6 months. During each course, participants will have a 2-day infusion of CPHPC, then two 6–8 h infusions of anti SAP mAb, while they’re also receiving CPHPC injections (up to 3 times-daily for 11 days). \n\nDuring each course of treatment, participants will stay on the ward for 13 days and make 2 outpatient visits. They’ll attend 3 follow-up visits after the final course. It’ll take at least 19 months to finish the study. \n\nA pharmaceutical company (GlaxoSmithKline) is funding the study.\n\n3 UK and 2 US centres will do the study.\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0498
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion