Brief Title
A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)
Official 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)
Brief Summary
The purpose of the study is to assess the safety and tolerability of UCB0107 in study
participants with Progressive Supranuclear Palsy (PSP).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of treatment emergent adverse events (TEAEs) from Baseline to the last Visit
Condition
Progressive Supranuclear Palsy
Intervention
bepranemab
Study Arms / Comparison Groups
bepranemab
Description: Subjects will be randomized to receive bepranemab.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
December 3, 2019
Completion Date
November 17, 2021
Primary Completion Date
November 17, 2021
Eligibility Criteria
Inclusion Criteria:
- Participant must be ≥40 years of age at the time of signing the informed consent
- Participants meet the criteria for possible or probable Progressive Supranuclear Palsy
(PSP) Richardson's Syndrome according the Movement Disorder Society (MDS)-PSP criteria
- Participant is able to walk at least 5 steps with minimal or no assistance
(stabilization of one arm or use of cane/walker)
- Participant has reliable caregiver support during the whole study period or the
participant is able to independently follow the study protocol
- Participant is stable on all treatments for at least 2 weeks prior to the Baseline
Visit
- Participant has a body mass index (BMI) within the range 16.0 to 32.0 kg/m^2
(inclusive)
- Participants can be male or female
- Participant (and caregiver or legal representative, if applicable) is capable of
giving signed informed consent which includes compliance with the requirements and
restrictions listed in the Informed Consent form (ICF) and in this protocol. Informed
consent must be obtained before initiating any study procedures
Exclusion Criteria:
- Ongoing, recurrent, severe headaches, including migraines
- Evidence of any clinically significant neurological disorder (including any clinically
significant abnormalities on the screening magnetic resonance imaging) other than
Progressive Supranuclear Palsy (PSP)
- Participant has a lifetime history of suicide attempt, or has suicidal ideation with
at least some intent to act in the past 12 months as indicated by a positive response
("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the
Columbia-suicide severity rating scale (C-SSRS) at Screening
- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that, in the opinion of the Investigator or medical monitor, contraindicates
participation in the study
- The following liver enzyme test results:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
phosphatase (ALP) are >2.0x upper limit of normal (ULN)
- Bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is
fractionated and direct bilirubin is <35 %)
- The mean QT interval value (corrected by Fredericia's formula for the heart rate,
QTcF) of the 3 Screening ECGs is >450 msec for male participants or >470 msec for
female participants or QTcF is >480 msec in participants with bundle branch block
- Abnormalities in lumbar spine previously known or determined by a Screening lumbar
x-ray (if conducted) that may jeopardize the execution of the lumbar puncture
- Participant was previously treated with tau-protein targeting drugs and/or tau-protein
targeting antibodies or vaccines.
- Treatment with biologic agents (such as monoclonal antibodies including marketed
drugs) within 3 months or 5 half-lives (whichever is longer) prior to the first dose
Gender
All
Ages
40 Years - N/A
Accepts Healthy Volunteers
No
Contacts
UCB Cares, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04185415
Organization ID
PSP003
Secondary IDs
2019-002377-61
Responsible Party
Sponsor
Study Sponsor
UCB Biopharma SRL
Study Sponsor
UCB Cares, Study Director, 001 844 599 2273 (UCB)
Verification Date
December 2022