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

Primary Purpose

Progressive Supranuclear Palsy

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
UCB0107 (bepranemab)
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Progressive supranuclear palsy, UCB0107, Phase 1B study, PSP, Bepranemab

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psp002 40122
  • Psp002 40002
  • Psp002 40277
  • Psp002 40276
  • Psp002 40278
  • Psp002 40024
  • Psp002 40267
  • Psp002 40100
  • Psp002 40268
  • Psp002 40175
  • Psp002 40165

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UCB0107 (bepranemab)

Arm Description

Subjects in this study arm will receive Intravenous UCB0107.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 1, 2020
Last Updated
October 19, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04658199
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
March 30, 2027 (Anticipated)
Study Completion Date
March 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy
Keywords
Progressive supranuclear palsy, UCB0107, Phase 1B study, PSP, Bepranemab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UCB0107 (bepranemab)
Arm Type
Experimental
Arm Description
Subjects in this study arm will receive Intravenous UCB0107.
Intervention Type
Drug
Intervention Name(s)
UCB0107 (bepranemab)
Intervention Description
UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
Description
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).
Time Frame
From Baseline of the open-label extension to end of study visit (Month 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Psp002 40122
City
Edegem
Country
Belgium
Facility Name
Psp002 40002
City
Leuven
Country
Belgium
Facility Name
Psp002 40277
City
Bochum
Country
Germany
Facility Name
Psp002 40276
City
Düsseldorf
Country
Germany
Facility Name
Psp002 40278
City
Essen
Country
Germany
Facility Name
Psp002 40024
City
Hannover
Country
Germany
Facility Name
Psp002 40267
City
Barcelona
Country
Spain
Facility Name
Psp002 40100
City
Madrid
Country
Spain
Facility Name
Psp002 40268
City
Pamplona
Country
Spain
Facility Name
Psp002 40175
City
London
Country
United Kingdom
Facility Name
Psp002 40165
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Learn more about this trial

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

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