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Trial record 1 of 1 for:    PSP003 | Progressive Supranuclear Palsy | Germany
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A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185415
Recruitment Status : Active, not recruiting
First Posted : December 4, 2019
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of the study is to assess the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: bepranemab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: bepranemab
Subjects will be randomized to receive bepranemab.
Drug: bepranemab

bepranemab will be administered in a predefined dosage.

  • Pharmaceutical Form: Solution for infusion
  • Route of Administration: Intravenous
Other Name: UCB0107

Placebo Comparator: Placebo
Subjects will be randomized to receive Placebo.
Drug: Placebo
  • Pharmaceutical Form: Solution for infusion
  • Concentration: 0.9% w/v sodium chloride aqueous solution
  • Route of Administration: Intravenous




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) from Baseline to the last Visit [ Time Frame: From Baseline up to Week 68 ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185415


Locations
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Belgium
Psp003 40122
Edegem, Belgium
Psp003 40002
Leuven, Belgium
Germany
Psp003 40277
Bochum, Germany
Psp003 40276
Düsseldorf, Germany
Psp003 40278
Essen, Germany
Psp003 40024
Hannover, Germany
Spain
Psp003 40159
Barcelona, Spain
Psp003 40267
Barcelona, Spain
Psp003 40100
Madrid, Spain
Psp003 40268
Madrid, Spain
United Kingdom
Psp003 40166
London, United Kingdom
Psp003 40175
London, United Kingdom
Psp003 40165
Southampton, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04185415    
Other Study ID Numbers: PSP003
2019-002377-61 ( EudraCT Number )
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Progressive Supranuclear Palsy
UCB0107
Phase 1 study
PSP
Additional relevant MeSH terms:
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Paralysis
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases