Phase 2b extension study to evaluate NEOD001 in Light Chain (AL)
Research type
Research Study
Full title
A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
IRAS ID
226880
Contact name
Ashutosh Wechalekar
Contact email
Sponsor organisation
Prothena Therapeutics Limited
Eudract number
2016-004664-18
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
Light Chain (AL) Amyloidosis is a rare disorder. With an estimated total population of 63.7 million, the overall incidence of systemic amyloidosis in England may be approximately 500 per year.
This extension study will consider the safety and efficacy of the study drug NEOD001, an antibody that was developed to target the abnormal protein (amyloid) that causes AL amyloidosis. NEOD001 might reduce the amyloid build up and/or the damage caused by amyloid,and may improve abnormal organ function.
This is a multicentre, Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (EudraCT No. 2015-004318-14).
The study will be conducted in approximately 40 sites globally and is anticipated to enroll 100 subjects. Each subject’s study participation may be up to 38 months or until the study is terminated.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0223
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion