Active not recruitingPhase 1

A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

An Open-Label Extension Study to Evaluate the Safety and Tolerability of Long-Term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

Lead sponsor

UCB Biopharma SRL

Asset

Bepranemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Age ≥40

Primary endpoint

•Treatment emergent adverse events from Baseline of the open-label extension

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

Registry2024-510951-36EU CT Number

NCT IDNCT04658199

Org study IDPSP002

Secondary IDU1111-1304-3004Universal Trial Number (UTN)

Timeline

Milestones

Study start2020-11-16actual

Study first posted2020-12-08actual

Last update posted2025-07-29actual

Primary completion2027-12-13estimated

Study completion2027-12-13estimated

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 meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Hoeglinger et al, 2017)

•Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 (NCT04185415)

•Participant can be male or female

a)A male participant must agree to use contraception as detailed in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period

b)A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

i.Not a woman of childbearing potential (WOCBP) OR

ii.A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment.

•Participant (or legal representative, as applicable and acceptable by local regulations) is giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent must be obtained before initiating any study procedures

Exclusion criteria

•Participant has met a mandatory withdrawal and/or stopping criterion in PSP003 (NCT04185415)

•Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003 (NCT04185415), or has current suicidal ideation with at least some intent to act as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia Suicide Severity Rating Scale (CSSRS) at the Day 1 Visit. However, participants will not be excluded if, based upon a mental healthcare professional assessment, and the investigator's judgment of benefit/risk, the participant is deemed suitable for receiving study medication

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 from Baseline of the open-label extension to the end of the study

Time frame:From Baseline of the open-label extension to end of study visit (up to 7 years)

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.