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

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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

NCT04658199•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (11)

Psp002 40122

Edegem, Belgium

Psp002 40002

Leuven, Belgium

Psp002 40277

Bochum, Germany

Psp002 40276

Düsseldorf, Germany

Psp002 40278

Essen, Germany

Psp002 40024

Hanover, Germany

Psp002 40267

Barcelona, Spain

Psp002 40100

Madrid, Spain

Psp002 40268

Pamplona, Spain

Psp002 40175

London, United Kingdom

Key Dates

Start Date

November 16, 2020

Primary Completion Date

December 13, 2027

Completion Date

December 13, 2027

Last Updated

July 29, 2025

Enrollment

ACTUAL participants

Conditions

Progressive Supranuclear Palsy

Interventions

UCB0107 (bepranemab)

DRUG

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Frontotemporal Degeneration(FTD)Primary Progressive Aphasia(PPA)+7 more

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RECRUITINGNA

The Swedish BioFINDER 2 Study

NCT03174938

DementiaAlzheimer Disease+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

UPenn Observational Research Repository on Neurodegenerative Disease

The Swedish BioFINDER 2 Study

The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

Modifiable Variables in Parkinsonism (MVP)

Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely