A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

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Brief Title

A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

Official Title

A Participant-Blind, Investigator-Blind, Placebo-Controlled, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

Brief Summary

      The purpose of the study is to assess the 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 (TEAEs) from Baseline to the last Visit


Condition

Progressive Supranuclear Palsy

Intervention

bepranemab

Study Arms / Comparison Groups

 bepranemab
Description:  Subjects will be randomized to receive bepranemab.

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

25

Start Date

December 3, 2019

Completion Date

April 2022

Primary Completion Date

November 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Participant must be ≥40 years of age at the time of signing the informed consent

          -  Participants meet the criteria for possible or probable Progressive Supranuclear Palsy
             (PSP) Richardson's Syndrome according the Movement Disorder Society (MDS)-PSP criteria

          -  Participant is able to walk at least 5 steps with minimal or no assistance
             (stabilization of one arm or use of cane/walker)

          -  Participant has reliable caregiver support during the whole study period or the
             participant is able to independently follow the study protocol

          -  Participant is stable on all treatments for at least 2 weeks prior to the Baseline
             Visit

          -  Participant has a body mass index (BMI) within the range 16.0 to 32.0 kg/m^2
             (inclusive)

          -  Participants can be male or female

          -  Participant (and caregiver or legal representative, if applicable) is capable of
             giving signed informed consent which includes compliance with the requirements and
             restrictions listed in the Informed Consent form (ICF) and in this protocol. Informed
             consent must be obtained before initiating any study procedures

        Exclusion Criteria:

          -  Ongoing, recurrent, severe headaches, including migraines

          -  Evidence of any clinically significant neurological disorder (including any clinically
             significant abnormalities on the screening magnetic resonance imaging) other than
             Progressive Supranuclear Palsy (PSP)

          -  Participant has a lifetime history of suicide attempt, or has suicidal ideation with
             at least some intent to act in the past 12 months as indicated by a positive response
             ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the
             Columbia-suicide severity rating scale (C-SSRS) at Screening

          -  Sensitivity to any of the study interventions, or components thereof, or drug or other
             allergy that, in the opinion of the Investigator or medical monitor, contraindicates
             participation in the study

          -  The following liver enzyme test results:

               -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
                  phosphatase (ALP) are >2.0x upper limit of normal (ULN)

               -  Bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is
                  fractionated and direct bilirubin is <35 %)

          -  The mean QT interval value (corrected by Fredericia's formula for the heart rate,
             QTcF) of the 3 Screening ECGs is >450 msec for male participants or >470 msec for
             female participants or QTcF is >480 msec in participants with bundle branch block

          -  Abnormalities in lumbar spine previously known or determined by a Screening lumbar
             x-ray (if conducted) that may jeopardize the execution of the lumbar puncture

          -  Participant was previously treated with tau-protein targeting drugs and/or tau-protein
             targeting antibodies or vaccines.

          -  Treatment with biologic agents (such as monoclonal antibodies including marketed
             drugs) within 3 months or 5 half-lives (whichever is longer) prior to the first dose
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

UCB Cares, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04185415

Organization ID

PSP003

Secondary IDs

2019-002377-61

Responsible Party

Sponsor

Study Sponsor

UCB Biopharma SRL


Study Sponsor

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


Verification Date

October 2021