PSP002
PSP002
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).Medical Condition
Progressive Supranuclear Palsy
Min. Age
40
Years
Max. Age
-
Who Can Join?
All
Status
Active, not recruiting
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 (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 Medication Description
Study Medication:
bepranemab
Other Descriptive Name:
bepranemab
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
November 2020
Actual Start Date of Enrollment
March 2027
Planned Study Completion Date
General Information
Study ID:
PSP002
EudraCT Number:
2019-001127-12
CT.gov Number:
NCT04658199
Phase:
Phase 1