Clinical trial • Phase III • Neurology
BEPRANEMAB for Progressive supranuclear palsy
Phase III trial of BEPRANEMAB for Progressive supranuclear palsy. open-label. 17 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Progressive supranuclear palsy
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 15-05-2024
- First CTIS Authorization Date
- 25-06-2024
Trial design
open-label Phase III trial in Belgium, Germany, Spain.
- Open Label
- Yes
- Target Sample Size
- 17
Eligibility
Recruits 17 Informed consent provisions for vulnerable participants: "Participant (or legal representative, as applicable and acceptable by local regulations) is 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." Consent may be provided by the legal representative where applicable..
- Pregnancy Exclusion
- 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.
- Vulnerable Population
- Informed consent provisions for vulnerable participants: "Participant (or legal representative, as applicable and acceptable by local regulations) is 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." Consent may be provided by the legal representative where applicable.
Inclusion criteria
- {"criterion_text":"- Participant meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Höglinger et al, 2017)"}
- {"criterion_text":"- Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Participant (or legal representative, as applicable and acceptable by local regulations) is 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
- {"criterion_text":"- Participant has met a mandatory withdrawal and/or stopping criterion in PSP003"}
- {"criterion_text":"- Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003, 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 (C-SSRS) 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 17
- Recruitment Window Months
- 84
- Consent Approach
- Signed informed consent must be obtained before initiating any study procedures. Consent may be given by the participant or by a legal representative where applicable ('Participant (or legal representative, as applicable and acceptable by local regulations) is giving signed informed consent...'). Subject information and informed consent forms are available in multiple languages as published (examples include English, French, Dutch, Spanish and German). No separate assent process for minors is described (study population is adults).
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 17
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 477
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- #40122: Neurology
- Contact Person Name
- Patrick Cras
- Contact Person Email
- patrick.cras@uantwerpen.be
- Site Name
- UZ Leuven
- Department Name
- #40002: Neurology
- Contact Person Name
- Wim Vandenberghe
- Contact Person Email
- wim.vandenberghe@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 477
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- #40024: Klinik für Neurologie mit klinischer Neurophysiologie
- Contact Person Name
- Guenter Hoeglinger
- Contact Person Email
- hoeglinger.guenter@mh-hannover.de
- Site Name
- Katholische Kliniken Ruhrhalbinsel gGmbH
- Department Name
- #40278: Klinik für Neurologie
- Contact Person Name
- Dirk Woitalla
- Contact Person Email
- d.woitalla@contilia.de
Spain
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 25-07-2025
- Processing Time Days
- 478
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- #40268: Unidad Central de Ensayos Clinicos
- Contact Person Name
- Maria Cruz Rodriguez Oroz
- Contact Person Email
- mcroroz@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- #40267: Escalera 8, planta 4 servicio de neurologia
- Contact Person Name
- Yaroslau Compta Hirnyj
- Contact Person Email
- ycompta@clinic.cat
Sponsor
Primary sponsor
- Full Name
- UCB Biopharma
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- Electronic Clinical Outcome Assesments data capture
- Name
- Icon Clinical Research Limited
- Name
- Pharmaceutical Research Associates Group B.V.
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic Case Report Form data capture
- Name
- Perceptive Eclinical Limited
- Name
- Eresearchtechnology Inc.
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Electronic Clinical Outcome Assesments data capture","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"","organisation_type":"Patient organisation/association"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic Case Report Form data capture","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"Patient Logistics Management","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Bepranemab
- Active Substance
- BEPRANEMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- No marketing authorization
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