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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2027-12-13

Brief Summary

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The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).

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Detailed Description

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Conditions

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Progressive Supranuclear Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCB0107 (bepranemab)

Subjects in this study arm will receive Intravenous UCB0107.

Group Type EXPERIMENTAL

UCB0107 (bepranemab)

Intervention Type DRUG

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

Interventions

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UCB0107 (bepranemab)

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

Intervention Type DRUG

Eligibility Criteria

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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 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No