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A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

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ClinicalTrials.gov Identifier: NCT04658199
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2020
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: UCB0107 (bepranemab) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Safety and Tolerability of Long-Term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026


Arm Intervention/treatment
Experimental: UCB0107 (bepranemab)
Subjects in this study arm will receive Intravenous UCB0107.
Drug: UCB0107 (bepranemab)
UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study [ Time Frame: From Baseline of the open-label extension to end of study visit (Month 60) ]
    An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Hoeglinger et al, 2017)
  • Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 (NCT04185415)
  • 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.

  • Participant (or legal representative, as applicable and acceptable by local regulations) is capable of 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:

  • Participant has met a mandatory withdrawal and/or stopping criterion in PSP003 (NCT04185415)
  • Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003 (NCT04185415), 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 Screening. However, participants will not be excluded if, based upon a mental healthcare professional assessment, the investigator's judgment of benefit/risk, and, in consultation with the Medical Monitor, the participant is deemed suitable for receiving study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658199


Locations
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Belgium
Psp002 40122
Edegem, Belgium
Psp002 40002
Leuven, Belgium
Germany
40277 Psp002
Bochum, Germany
Psp002 40024
Hannover, Germany
Spain
Psp002 40267
Barcelona, Spain
Psp002 40100
Madrid, Spain
Psp002 40268
Pamplona, Spain
United Kingdom
40175 Psp002
London, United Kingdom
Psp002 40165
Southampton, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04658199    
Other Study ID Numbers: PSP002
2019-001127-12 ( EudraCT Number )
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Progressive supranuclear palsy
UCB0107
Phase 1B study
PSP
Bepranemab
Additional relevant MeSH terms:
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Paralysis
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases