Brief Title
A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy
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
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).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
Condition
Progressive Supranuclear Palsy
Intervention
UCB0107 (bepranemab)
Study Arms / Comparison Groups
UCB0107 (bepranemab)
Description: Subjects in this study arm will receive Intravenous UCB0107.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
November 16, 2020
Completion Date
November 2026
Primary Completion Date
November 2026
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
UCB Cares, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04658199
Organization ID
PSP002
Secondary IDs
2019-001127-12
Responsible Party
Sponsor
Study Sponsor
UCB Biopharma SRL
Study Sponsor
UCB Cares, Study Director, 001 844 599 2273 (UCB)
Verification Date
October 2021