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

Progressive Supranuclear Palsy Clinical Trial

Official title:

A Participant-Blind, Investigator-Blind, Placebo-Controlled, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185415
• Other study ID #: PSP003
• Secondary ID: 2019-002377-61
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2019
• Est. completion date: November 17, 2021

Study information

• Verified date: November 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• bepranemab
bepranemab will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous
• Placebo
Pharmaceutical Form: Solution for infusion Concentration: 0.9% w/v sodium chloride aqueous solution Route of Administration: Intravenous

Locations

Country	Name	City	State
Belgium	Psp003 40122	Edegem
Belgium	Psp003 40002	Leuven
Germany	Psp003 40277	Bochum
Germany	Psp003 40276	Düsseldorf
Germany	Psp003 40278	Essen
Germany	Psp003 40024	Hannover
Spain	Psp003 40159	Barcelona
Spain	Psp003 40267	Barcelona
Spain	Psp003 40100	Madrid
Spain	Psp003 40268	Madrid
United Kingdom	Psp003 40166	London
United Kingdom	Psp003 40175	London
United Kingdom	Psp003 40165	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

Belgium,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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