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

NCT04658199 | Active Not Recruiting Phase 1

• 3 other identifiers: PSP002U1111-1304-30042024-510951-36
• Study Type: interventional
• Target: 19
• Locations: 4 countries
• Sites: 11

Brief 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).

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive supranuclear palsy; UCB0107; Phase 1B study; PSP; Bepranemab

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study

  An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).

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

Study Arms (1)

UCB0107 (bepranemab)

EXPERIMENTAL

Subjects in this study arm will receive Intravenous UCB0107.

Drug: UCB0107 (bepranemab)

Interventions

UCB0107 (bepranemab) DRUG

UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous

UCB0107 (bepranemab)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (11)

Psp002 40122

Edegem, Belgium

Location

Psp002 40002

Leuven, Belgium

Location

Psp002 40277

Bochum, Germany

Location

Psp002 40276

Düsseldorf, Germany

Location

Psp002 40278

Essen, Germany

Location

Psp002 40024

Hanover, Germany

Location

Psp002 40267

Barcelona, Spain

Location

Psp002 40100

Madrid, Spain

Location

Psp002 40268

Pamplona, Spain

Location

Psp002 40175

London, United Kingdom

Location

Psp002 40165

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: November 16, 2020
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): December 13, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); BE (2); ES (3); DE (4)