UCB0107 (bepranemab): UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous
Study 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).
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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 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 (CSSRS) 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
Primary outcome measure(s)
Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study — From Baseline of the open-label extension to end of study visit (up to 7 years) 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).
Trial sites (11)
Facility
City
Region
Status
Psp002 40122
Edegem
Belgium
Psp002 40002
Leuven
Belgium
Psp002 40277
Bochum
Germany
Psp002 40276
Düsseldorf
Germany
Psp002 40278
Essen
Germany
Psp002 40024
Hanover
Germany
Psp002 40267
Barcelona
Spain
Psp002 40100
Madrid
Spain
Psp002 40268
Pamplona
Spain
Psp002 40175
London
United Kingdom
Psp002 40165
Southampton
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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