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

NCT04185415 | Completed Phase 1 DMC

• 2 other identifiers: PSP0032019-002377-61
• Study Type: interventional
• Target: 25
• Locations: 4 countries
• Sites: 13

Brief Summary

The purpose of the study is to assess the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy; UCB0107; Phase 1 study; PSP

Outcome Measures

Primary Outcomes (1)

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

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  From Baseline up to Week 68

Study Arms (2)

bepranemab

EXPERIMENTAL

Subjects will be randomized to receive bepranemab.

Drug: bepranemab

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive Placebo.

Drug: Placebo

Interventions

bepranemab DRUG

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

Also known as: UCB0107

bepranemab

Placebo DRUG

* Pharmaceutical Form: Solution for infusion * Concentration: 0.9% w/v sodium chloride aqueous solution * Route of Administration: Intravenous

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (13)

Psp003 40122

Edegem, Belgium

Location

Psp003 40002

Leuven, Belgium

Location

Psp003 40277

Bochum, Germany

Location

Psp003 40276

Düsseldorf, Germany

Location

Psp003 40278

Essen, Germany

Location

Psp003 40024

Hanover, Germany

Location

Psp003 40159

Barcelona, Spain

Location

Psp003 40267

Barcelona, Spain

Location

Psp003 40100

Madrid, Spain

Location

Psp003 40268

Madrid, Spain

Location

Psp003 40166

London, United Kingdom

Location

Psp003 40175

London, United Kingdom

Location

Psp003 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: December 3, 2019
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

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