CompletedPhase 1

A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

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)

Lead sponsor

UCB Biopharma SRL

Asset

Bepranemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment emergent adverse events (TEAEs) from Baseline to the last Visit

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2019-002377-61

NCT IDNCT04185415

Org study IDPSP003

Timeline

Milestones

Study start2019-12-03actual

Study first posted2019-12-04actual

Primary completion2021-11-17actual

Study completion2021-11-17actual

Last update posted2023-12-01actual

Assets

Drug assets

Bepranemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of treatment emergent adverse events (TEAEs) from Baseline to the last Visit

Time frame:From Baseline up to Week 68

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.