PSP003:A Phase 1b study of UCB0107 in participants with PSP
Research type
Research Study
Full title
A participant-blind, Investigator-blind, placebo-controlled, Phase 1b study to evaluate the safety, tolerability, and pharmacokinetics of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).
IRAS ID
270906
Contact name
Shikiko Watanabe
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2019-002377-61
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
Progressive supranuclear palsy (PSP) is a neurodegenerative disorder which causes instability with falls, changes in gait, gaze palsy(inability to move both eyes in the same direction at the same time), cognitive impairment, personality changes, and speech and swallowing deficits that can ultimately lead to death. There are no medicines approved for the treatment of PSP, and the medicines currently used to treat PSP only target the symptoms of the disease, not the underlying cause.\n\nPSP is caused by tau proteins. Tau is a type of protein normally found in the neurons (specialised cell in the brain), but in PSP it has lost its correct shape and this misshapen tau spreads in the brain and damages the brain neurons. The study drug (UCB0107), is an antibody which works by binding to a specific site of a tau protein in the brain. Treatment with UCB0107 may reduce spreading of tau proteins in the brain and this could slow or stop the worsening of PSP. This is the first time that the study drug will be given to people with PSP. The purpose of this trial is to investigate how safe the study drug (UCB0107) is and how well patients react to it (safety and tolerability). The trial will also investigate how the study drug is absorbed, distributed and broken down by the body.\n\nThis trial will involve at least 16 study participants, enroled at 23 participating sites located in 6 countries. \n\n\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0520
Date of REC Opinion
28 Jan 2020
REC opinion
Further Information Favourable Opinion