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

• ClinicalTrials.gov Identifier: NCT04658199
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2020
• Last Update Posted: January 20, 2023
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Progressive Supranuclear Palsy	Drug: UCB0107 (bepranemab)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Extension Study to Evaluate the Safety and Tolerability of Long-Term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy
• Actual Study Start Date: November 16, 2020
• Estimated Primary Completion Date: November 2, 2026
• Estimated Study Completion Date: November 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: UCB0107 (bepranemab); Subjects in this study arm will receive Intravenous UCB0107.	Drug: UCB0107 (bepranemab); UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous

Outcome Measures

Primary Outcome Measures :

1. 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 (Month 60) ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 capable of 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

Contacts and Locations

Locations

Belgium

Psp002 40122

Edegem, Belgium

Psp002 40002

Leuven, Belgium

Germany

Psp002 40277

Bochum, Germany

Psp002 40276

Düsseldorf, Germany

Psp002 40278

Essen, Germany

Psp002 40024

Hannover, Germany

Spain

Psp002 40267

Barcelona, Spain

Psp002 40100

Madrid, Spain

Psp002 40268

Pamplona, Spain

United Kingdom

Psp002 40175

London, United Kingdom

Psp002 40165

Southampton, United Kingdom

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

• Study Director: UCB Cares; 001 844 599 2273 (UCB)

More Information

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT04658199
• Other Study ID Numbers: PSP002
• First Posted: December 8, 2020
• Last Update Posted: January 20, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma SRL ):

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

Additional relevant MeSH terms:

Paralysis; Supranuclear Palsy, Progressive; Neurologic Manifestations; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Eye Diseases