Clinical trial NCT04658199: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Progressive Supranuclear Palsy
Keywords: Progressive supranuclear palsy
UCB0107
Phase 1B study
PSP
Bepranemab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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 (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 outcomes:
measure: Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
timeFrame: From Baseline of the open-label extension to end of study visit (Month 60)
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Psp002 40122
city: Leuven
country: Belgium
facility: Psp002 40002
city: Bochum
country: Germany
facility: Psp002 40277
city: Düsseldorf
country: Germany
facility: Psp002 40276
city: Essen
country: Germany
facility: Psp002 40278
city: Hannover
country: Germany
facility: Psp002 40024
city: Barcelona
country: Spain
facility: Psp002 40267
city: Madrid
country: Spain
facility: Psp002 40100
city: Pamplona
country: Spain
facility: Psp002 40268
city: London
country: United Kingdom
facility: Psp002 40175
city: Southampton
country: United Kingdom
facility: Psp002 40165
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: