Efficacy, Safety, and Tolerability of Bepranemab (UCB0107)
Research type
Research Study
Full title
A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer’s Disease (AD), Followed by an Open-Label Extension Period
IRAS ID
299120
Contact name
Christopher Kipps
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2020-005829-88
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The study is being performed in participants with early signs (prodromal signs) of Alzheimer’s disease (AD) or have a diagnosis of mild AD. This study is being developed to investigate the effect of bepranemab the study drug vs placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), a scale used to quantify the severity of symptoms of dementia, as the change from Baseline to Week 80 in the CDR-SB total score, in study participants with prodromal to mild AD.\nThis study will involve a total of 450 study participants across approximately 125 centres in about 10 countries throughout Europe and North America.\nThe study typically consists of a Screening Period (up to 60 days) and then a Double-blind Treatment Period of 80 weeks (18 months). If the participant decides to stop their participation at the end of these 80 weeks, they will be followed up for another 16 weeks of Safety Follow-up Period.\nThere is an option for the participant to continue receiving the study drug and will then enter the Open-label Extension (OLE) Treatment Period. The participants study doctor will discuss this with participants and confirm their eligibility to take part in this open label study. The OLE Period then continues with 44 weeks of treatment to Week 124. Once the treatment period has ended, the participant will enter the Safety Follow-up Period and have the first visit 4 weeks later at Week 128, the Safety Follow-up Period lasting up to 20 weeks. \nIn total the duration is up to approximately 152 weeks (almost 3 years).\n\n\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0198
Date of REC Opinion
29 Jul 2021
REC opinion
Further Information Favourable Opinion