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

Sponsor

UCB Biopharma SRL (Industry)

Overall Status

Completed

CT.gov ID

NCT04185415

Collaborator

(none)

Enrollment

Locations

Arms

23.5

Actual Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 3, 2019

Actual Primary Completion Date :

Nov 17, 2021

Actual Study Completion Date :

Nov 17, 2021

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

Incidence of treatment emergent adverse events (TEAEs) from Baseline to the last Visit [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Psp003 40122	Edegem	Belgium
2	Psp003 40002	Leuven	Belgium
3	Psp003 40277	Bochum	Germany
4	Psp003 40276	Düsseldorf	Germany
5	Psp003 40278	Essen	Germany
6	Psp003 40024	Hannover	Germany
7	Psp003 40159	Barcelona	Spain
8	Psp003 40267	Barcelona	Spain
9	Psp003 40100	Madrid	Spain
10	Psp003 40268	Madrid	Spain
11	Psp003 40166	London	United Kingdom
12	Psp003 40175	London	United Kingdom
13	Psp003 40165	Southampton	United Kingdom