PSP002: Extension Phase 1b study of UCB0107 on participants with PSP
Research type
Research Study
Full title
An open-label extension study to evaluate the safety and tolerability of long-term UCB0107 administration in study participants with progressive supranuclear palsy
IRAS ID
289630
Contact name
Huw Morris
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2019-001127-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
PIND, 139693
Duration of Study in the UK
5 years, 4 months, 26 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 currently used medicines only target the symptoms of the disease, not the underlying cause.
PSP is caused by tau proteins. These are proteins normally found in neurons (specialised cell in the brain), but in PSP it has lost its correct shape and this misshapen tau spreads in the brain damaging 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 study, PSP002 is an open label extension (OLE) study for participants who complete the ”feeder” study, PSP003. PSP003 is a double-blind safety and tolerability study of UCB0107 or placebo administered every 4 weeks (Q4W) evaluated in participants with PSP. PSP002 will consist of an Enrollment Visit (to align with the Week 48 Visit of PSP003) as part of the Treatment Period, and a Safety Follow-Up (SFU) Period.
Approximately 24 study participants may participate in PSP002. Participants will receive intravenous UCB0107 (90mg/kg) Q4W throughout the duration of the clinical development of UCB0107, and until marketing authorisation is granted and UCB0107 is commercially launched in the countries where the study is conducted, or until the sponsor decides to close the study, or until UCB107 development is stopped by the sponsor; however, the study will last no longer than a maximum of 5 years.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0036
Date of REC Opinion
3 Mar 2021
REC opinion
Further Information Favourable Opinion