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

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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

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).
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study


Condition

Progressive Supranuclear Palsy

Intervention

UCB0107 (bepranemab)

Study Arms / Comparison Groups

 UCB0107 (bepranemab)
Description:  Subjects in this study arm will receive Intravenous UCB0107.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

November 16, 2020

Completion Date

November 2026

Primary Completion Date

November 2026

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 (C-SSRS) at Screening. However, participants will not be
             excluded if, based upon a mental healthcare professional assessment, the
             investigator's judgment of benefit/risk, and, in consultation with the Medical
             Monitor, the participant is deemed suitable for receiving study medication
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

UCB Cares, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04658199

Organization ID

PSP002

Secondary IDs

2019-001127-12

Responsible Party

Sponsor

Study Sponsor

UCB Biopharma SRL


Study Sponsor

UCB Cares, Study Director, 001 844 599 2273 (UCB)


Verification Date

October 2021