Clinical trial NCT05543252: An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
Official title: A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease.
UCB0599
Phase 2
Minzasolmin
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 428
Sex: ALL
Minimum age (years): 40
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.


Eligibility criteria: Inclusion Criteria

* Participant completed the Treatment Period of PD0053 (NCT04658186). The Baseline Visit for PD0055 (Visit 2) should be no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186). Any delay needs to be justified by the Investigator and approved by the Sponsor
* A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of the IMP and refrain from donating sperm during this period.
* A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

  ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of investigational medicinal product (IMP). The study participant must have a negative urine pregnancy test at Screening (Visit 1), which is to be confirmed negative by urine testing prior to the first dose of IMP at PD0055 Baseline Visit. If oral contraception is used, an additional barrier method will be required during the study as an IMP-related gastrointestinal upset or a drug interaction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy
* 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.

Exclusion Criteria:

* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
* Study participant had previously participated in PD0055
* Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
* Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
* Study participant does not agree to refrain from donating blood or blood products or other body fluids

Primary outcomes:
measure: Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 Month 18
timeFrame: From Baseline up to Month 18
Secondary outcomes:
measure: Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18
timeFrame: From Baseline up to Month 18
measure: Incidence of treatment-emergent adverse event (TEAEs)
timeFrame: From Baseline to the Safety Follow-up Visit (Month 31)
measure: Incidence of serious adverse events (SAEs)
timeFrame: From Baseline to the Safety Follow-up Visit (Month 31)
measure: Incidence of TEAEs leading to withdrawal from study
timeFrame: From Baseline to the Safety Follow-up Visit (Month 31)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pd0055 50506
state: Arizona
city: Fountain Valley
country: United States
facility: Pd0055 50519
state: California
city: Fresno
country: United States
facility: Pd0055 50385
state: California
city: Los Angeles
country: United States
facility: Pd0055 50118
state: California
city: Englewood
country: United States
facility: Pd0055 50531
state: Colorado
city: Danbury
country: United States
facility: Pd0055 50392
state: Connecticut
city: Farmington
country: United States
facility: Pd0055 50538
state: Connecticut
city: Boca Raton
country: United States
facility: Pd0055 50396
state: Florida
city: Bradenton
country: United States
facility: Pd0055 50524
state: Florida
city: Tampa
country: United States
facility: Pd0055 50394
state: Florida
city: Augusta
country: United States
facility: Pd0055 50544
state: Georgia
city: Chicago
country: United States
facility: Pd0055 50401
state: Illinois
city: Chicago
country: United States
facility: Pd0055 50310
state: Illinois
city: Winfield
country: United States
facility: Pd0055 50399
state: Illinois
city: Iowa City
country: United States
facility: Pd0055 50549
state: Iowa
city: Kansas City
country: United States
facility: Pd0055 50074
state: Kansas
city: Lexington
country: United States
facility: Pd0055 50121
state: Kentucky
city: New Orleans
country: United States
facility: Pd0055 50395
state: Louisiana
city: Baltimore
country: United States
facility: Pd0055 50547
state: Maryland
city: Boston
country: United States
facility: Pd0055 50243
state: Massachusetts
city: Worcester
country: United States
facility: Pd0055 50546
state: Massachusetts
city: Farmington Hills
country: United States
facility: Pd0055 50386
state: Michigan
city: Saint Paul
country: United States
facility: Pd0055 50536
state: Minnesota
city: Las Vegas
country: United States
facility: Pd0055 50397
state: Nevada
city: Stony Brook
country: United States
facility: Pd0055 50530
state: New York
city: Williamsville
country: United States
facility: Pd0055 50535
state: New York
city: Cleveland
country: United States
facility: Pd0055 50372
state: Ohio
city: Cleveland
country: United States
facility: Pd0055 50311
state: Ohio
city: Columbus
country: United States
facility: Pd0055 50255
state: Ohio
city: Tulsa
country: United States
facility: Pd0055 50398
state: Oklahoma
city: Charleston
country: United States
facility: Pd0055 50084
state: Oregon
city: Philadelphia
country: United States
facility: Pd0055 50526
state: Pennsylvania
city: Memphis
country: United States
facility: Pd0055 50543
state: Tennessee
city: Houston
country: United States
facility: Pd0055 50113
state: Texas
city: Houston
country: United States
facility: Pd0055 50525
state: Texas
city: San Antonio
country: United States
facility: Pd0055 50400
state: Texas
city: Burlington
country: United States
facility: Pd0055 50107
state: Vermont
city: Fairfax
country: United States
facility: Pd0055 50410
state: Virginia
city: Virginia Beach
country: United States
facility: Pd0055 50534
state: Virginia
city: Kirkland
country: United States
facility: Pd0055 50292
state: Washington
city: Crab Orchard
country: United States
facility: Pd0055 50402
state: West Virginia
city: Calgary
country: Canada
facility: Pd0055 50374
city: Ottawa
country: Canada
facility: Pd0055 50387
city: Toronto
country: Canada
facility: Pd0055 50389
city: Bordeaux
country: France
facility: Pd0055 40527
city: Créteil
country: France
facility: Pd0055 40424
city: Lille
country: France
facility: Pd0055 40526
city: Marseille
country: France
facility: Pd0055 40130
city: Nantes
country: France
facility: Pd0055 40635
city: Nimes
country: France
facility: Pd0055 40524
city: Paris
country: France
facility: Pd0055 40525
city: Strasbourg
country: France
facility: Pd0055 40131
city: Toulouse
country: France
facility: Pd0055 40528
city: Berlin
country: Germany
facility: Pd0055 40515
city: Bonn
country: Germany
facility: Pd0055 40138
city: Dresden
country: Germany
facility: Pd0055 40530
city: Erbach
country: Germany
facility: Pd0055 40711
city: Erlangen
country: Germany
facility: Pd0055 40023
city: Essen
country: Germany
facility: Pd0055 40710
city: Haag in Oberbayern
country: Germany
facility: Pd0055 40532
city: Kiel
country: Germany
facility: Pd0055 40249
city: Mainz
country: Germany
facility: Pd0055 40174
city: Marburg
country: Germany
facility: Pd0055 40529
city: Regensburg
country: Germany
facility: Pd0055 40531
city: Brescia
country: Italy
facility: Pd0055 40555
city: Padova
country: Italy
facility: Pd0055 40533
city: Roma
country: Italy
facility: Pd0055 40257
city: Roma
country: Italy
facility: Pd0055 40534
city: Terni
country: Italy
facility: Pd0055 40697
city: Nijmegen
country: Netherlands
facility: Pd0055 40359
city: Bydgoszcz
country: Poland
facility: Pd0055 40694
city: Jelenia Gora
country: Poland
facility: Pd0055 40719
city: Katowice
country: Poland
facility: Pd0055 40539
city: Krakow
country: Poland
facility: Pd0055 40538
city: Krakow
country: Poland
facility: Pd0055 40696
city: Lodz
country: Poland
facility: Pd0055 40700
city: Lublin
country: Poland
facility: Pd0055 40702
city: Oswiecim
country: Poland
facility: Pd0055 40535
city: Warszawa
country: Poland
facility: Pd0055 40536
city: Warszawa
country: Poland
facility: Pd0055 40699
city: Warszawa
country: Poland
facility: Pd0055 40705
city: A Coruña
country: Spain
facility: Pd0055 40045
city: Barcelona
country: Spain
facility: Pd0055 40159
city: Barcelona
country: Spain
facility: Pd0055 40267
city: Cordoba
country: Spain
facility: Pd0055 40046
city: Madrid
country: Spain
facility: Pd0055 40540
city: Móstoles
country: Spain
facility: Pd0055 40542
city: Pamplona
country: Spain
facility: Pd0055 40352
city: San Sebastián
country: Spain
facility: Pd0055 40541
city: Sevilla
country: Spain
facility: Pd0055 40049
city: London
country: United Kingdom
facility: Pd0055 40175
city: London
country: United Kingdom
facility: Pd0055 40543
city: London
country: United Kingdom
facility: Pd0055 40698
city: Motherwell
country: United Kingdom
facility: Pd0055 40544
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pd0055 40306
city: Plymouth
country: United Kingdom
facility: Pd0055 40457
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: