NEOD001 versus placebo in AL Amyloidosis
Research type
Research Study
Full title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis
IRAS ID
183416
Contact name
Ashutosh Wechalekar
Contact email
Sponsor organisation
Prothena Therapeutics Limited
Eudract number
2014-003865-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
This is a phase III, randomised, double-blind study to determine the efficacy and safety of NEOD001 plus chemotherapy vs placebo plus chemotherapy in patients with Light Chain (AL) Amyloidosis.
Approximately 236 people will participate in the study. Patients will be asked to visit their study doctor regularly for between 1.5 and 4 years, including the enrolment and treatment periods, depending on when in the study they enrol.
Eligible patients will be randomly assigned receive either placebo or the study drug.
A number of assessments and procedures will be performed during the study including physical examinations, blood, chemotherapy administration, assessment questionnaires and urine sample assessments, echocardiograms (ECHO) and electrocardiograms (ECG). These assessments are performed as part of the evaluation to determine if the study drug is effective and safe.
The study will be run at approximately 6 centres in the UK and is sponsored by Prothena Therapeutics Limited.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1236
Date of REC Opinion
14 Aug 2015
REC opinion
Favourable Opinion