- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185415
A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)
November 27, 2023 updated by: UCB Biopharma SRL
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)
The purpose of the study is to assess the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edegem, Belgium
- Psp003 40122
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Leuven, Belgium
- Psp003 40002
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Bochum, Germany
- Psp003 40277
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Düsseldorf, Germany
- Psp003 40276
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Essen, Germany
- Psp003 40278
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Hannover, Germany
- Psp003 40024
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Barcelona, Spain
- Psp003 40159
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Barcelona, Spain
- Psp003 40267
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Madrid, Spain
- Psp003 40100
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Madrid, Spain
- Psp003 40268
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London, United Kingdom
- Psp003 40166
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London, United Kingdom
- Psp003 40175
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Southampton, United Kingdom
- Psp003 40165
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: bepranemab
Subjects will be randomized to receive bepranemab.
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bepranemab will be administered in a predefined dosage.
Other Names:
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Placebo Comparator: Placebo
Subjects will be randomized to receive Placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of treatment emergent adverse events (TEAEs) from Baseline to the last Visit
Time Frame: From Baseline up to Week 68
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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.
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From Baseline up to Week 68
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2019
Primary Completion (Actual)
November 17, 2021
Study Completion (Actual)
November 17, 2021
Study Registration Dates
First Submitted
December 2, 2019
First Submitted That Met QC Criteria
December 2, 2019
First Posted (Actual)
December 4, 2019
Study Record Updates
Last Update Posted (Estimated)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSP003
- 2019-002377-61 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Progressive Supranuclear Palsy
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Novartis PharmaceuticalsActive, not recruitingProgressive Supranuclear Palsy (PSP)Germany, United Kingdom, Canada, United States
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AbbVieTerminatedProgressive Supranuclear Palsy (PSP)United States, Australia, Canada, Italy, Japan
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AbbVieCompletedProgressive Supranuclear Palsy (PSP)United States
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Assistance Publique Hopitaux De MarseilleCompletedProgressive Supranuclear Palsy (PSP)France
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Oregon Health and Science UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingSupranuclear Palsy, Progressive | Palsy SupranuclearUnited States
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University of California, San FranciscoNational Institutes of Health (NIH); National Institute on Aging (NIA)Active, not recruitingProgressive Supranuclear Palsy (PSP) | Corticobasal Degeneration (CBD) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Corticobasal Syndrome (CBS) | Cortical-basal Ganglionic Degeneration (CBGD) | Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP)United States, Canada
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University of California, San FranciscoTau Consortium; CBD SolutionsCompletedProgressive Supranuclear Palsy (PSP) | Corticobasal Degeneration (CBD) | Corticobasal Syndrome (CBS) | Primary Four Repeat Tauopathies (4RT)United States
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Centre Hospitalier Universitaire de Pointe-a-PitreGroupe Hospitalier Pitie-Salpetriere; University Hospital Center of MartiniqueCompletedProgressive Supranuclear Palsy
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University of LouisvilleCompletedProgressive Supranuclear PalsyUnited States
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Groupe Hospitalier Pitie-SalpetriereInstitut National de la Santé Et de la Recherche Médicale, FranceUnknownSupranuclear Palsy, ProgressiveFrance
Clinical Trials on bepranemab
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UCB Biopharma SRLActive, not recruitingProgressive Supranuclear PalsyBelgium, Germany, Spain, United Kingdom
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UCB Biopharma SRLActive, not recruitingAlzheimer's DiseaseUnited States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom