A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy

Progressive Supranuclear Palsy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04658199
• Other study ID #: PSP002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 16, 2020
• Est. completion date: March 30, 2027

Study information

• Verified date: March 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• UCB0107 (bepranemab)
UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous

Locations

Country	Name	City	State
Belgium	Psp002 40122	Edegem
Belgium	Psp002 40002	Leuven
Germany	Psp002 40277	Bochum
Germany	Psp002 40276	Düsseldorf
Germany	Psp002 40278	Essen
Germany	Psp002 40024	Hannover
Spain	Psp002 40267	Barcelona
Spain	Psp002 40100	Madrid
Spain	Psp002 40268	Pamplona
United Kingdom	Psp002 40175	London
United Kingdom	Psp002 40165	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

Belgium,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study	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).	From Baseline of the open-label extension to end of study visit (Month 60)