A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)
NCT ID: NCT04185415
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2019-12-03
2021-11-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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bepranemab
Subjects will be randomized to receive bepranemab.
bepranemab
bepranemab will be administered in a predefined dosage.
* Pharmaceutical Form: Solution for infusion
* Route of Administration: Intravenous
Placebo
Subjects will be randomized to receive Placebo.
Placebo
* Pharmaceutical Form: Solution for infusion
* Concentration: 0.9% w/v sodium chloride aqueous solution
* Route of Administration: Intravenous
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Psp003 40122
Edegem, , Belgium
Psp003 40002
Leuven, , Belgium
Psp003 40277
Bochum, , Germany
Psp003 40276
Düsseldorf, , Germany
Psp003 40278
Essen, , Germany
Psp003 40024
Hanover, , Germany
Psp003 40159
Barcelona, , Spain
Psp003 40267
Barcelona, , Spain
Psp003 40100
Madrid, , Spain
Psp003 40268
Madrid, , Spain
Psp003 40166
London, , United Kingdom
Psp003 40175
London, , United Kingdom
Psp003 40165
Southampton, , United Kingdom
Countries
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Other Identifiers
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2019-002377-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PSP003
Identifier Type: -
Identifier Source: org_study_id