A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy
- Conditions
- Progressive Supranuclear Palsy
- Interventions
- Drug: UCB0107 (bepranemab)
- Registration Number
- NCT04658199
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 19
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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)
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Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 (NCT04185415)
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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.
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UCB0107 (bepranemab) UCB0107 (bepranemab) Subjects in this study arm will receive Intravenous UCB0107.
- Primary Outcome Measures
Name Time Method 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 (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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Psp002 40002
🇧🇪Leuven, Belgium
Psp002 40122
🇧🇪Edegem, Belgium
Psp002 40277
🇩🇪Bochum, Germany
Psp002 40278
🇩🇪Essen, Germany
Psp002 40268
🇪🇸Pamplona, Spain
Psp002 40276
🇩🇪Düsseldorf, Germany
Psp002 40267
🇪🇸Barcelona, Spain
Psp002 40165
🇬🇧Southampton, United Kingdom
Psp002 40175
🇬🇧London, United Kingdom
Psp002 40024
🇩🇪Hannover, Germany
Psp002 40100
🇪🇸Madrid, Spain