An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
NCT ID: NCT05543252
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
428 participants
INTERVENTIONAL
2022-08-29
2025-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Minzasolmin (UCB0599) High Dose Arm
Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.
Minzasolmin (UCB0599)
Minzasolmin (UCB0599) Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive minzasolmin (UCB0599) in a pre-specified sequence during the Treatment Period.
Minzasolmin (UCB0599) Low Dose Arm
Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
Minzasolmin (UCB0599)
Minzasolmin (UCB0599) Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive minzasolmin (UCB0599) in a pre-specified sequence during the Treatment Period.
Interventions
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Minzasolmin (UCB0599)
Minzasolmin (UCB0599) Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive minzasolmin (UCB0599) in a pre-specified sequence during the Treatment Period.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
78 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Pd0055 50506
Phoenix, Arizona, United States
Pd0055 50519
Fountain Valley, California, United States
Pd0055 50385
Fresno, California, United States
Pd0055 50118
Los Angeles, California, United States
Pd0055 50531
Englewood, Colorado, United States
Pd0055 50392
Danbury, Connecticut, United States
Pd0055 50538
Farmington, Connecticut, United States
Pd0055 50396
Boca Raton, Florida, United States
Pd0055 50524
Bradenton, Florida, United States
Pd0055 50394
Tampa, Florida, United States
Pd0055 50544
Augusta, Georgia, United States
Pd0055 50401
Chicago, Illinois, United States
Pd0055 50310
Chicago, Illinois, United States
Pd0055 50399
Winfield, Illinois, United States
Pd0055 50549
Iowa City, Iowa, United States
Pd0055 50074
Kansas City, Kansas, United States
Pd0055 50121
Lexington, Kentucky, United States
Pd0055 50395
New Orleans, Louisiana, United States
Pd0055 50547
Baltimore, Maryland, United States
Pd0055 50243
Boston, Massachusetts, United States
Pd0055 50546
Worcester, Massachusetts, United States
Pd0055 50386
Farmington Hills, Michigan, United States
Pd0055 50536
Saint Paul, Minnesota, United States
Pd0055 50397
Las Vegas, Nevada, United States
Pd0055 50530
Stony Brook, New York, United States
Pd0055 50535
Williamsville, New York, United States
Pd0055 50372
Cleveland, Ohio, United States
Pd0055 50311
Cleveland, Ohio, United States
Pd0055 50255
Columbus, Ohio, United States
Pd0055 50398
Tulsa, Oklahoma, United States
Pd0055 50084
Charleston, Oregon, United States
Pd0055 50526
Philadelphia, Pennsylvania, United States
Pd0055 50543
Memphis, Tennessee, United States
Pd0055 50113
Houston, Texas, United States
Pd0055 50525
Houston, Texas, United States
Pd0055 50400
San Antonio, Texas, United States
Pd0055 50107
Burlington, Vermont, United States
Pd0055 50410
Fairfax, Virginia, United States
Pd0055 50534
Virginia Beach, Virginia, United States
Pd0055 50292
Kirkland, Washington, United States
Pd0055 50402
Crab Orchard, West Virginia, United States
Pd0055 50374
Calgary, , Canada
Pd0055 50387
Ottawa, , Canada
Pd0055 50389
Toronto, , Canada
Pd0055 40527
Bordeaux, , France
Pd0055 40424
Créteil, , France
Pd0055 40526
Lille, , France
Pd0055 40130
Marseille, , France
Pd0055 40635
Nantes, , France
Pd0055 40524
Nîmes, , France
Pd0055 40525
Paris, , France
Pd0055 40131
Strasbourg, , France
Pd0055 40528
Toulouse, , France
Pd0055 40515
Berlin, , Germany
Pd0055 40138
Bonn, , Germany
Pd0055 40530
Dresden, , Germany
Pd0055 40711
Erbach im Odenwald, , Germany
Pd0055 40023
Erlangen, , Germany
Pd0055 40710
Essen, , Germany
Pd0055 40532
Haag in Oberbayern, , Germany
Pd0055 40249
Kiel, , Germany
Pd0055 40174
Mainz, , Germany
Pd0055 40529
Marburg, , Germany
Pd0055 40531
Regensburg, , Germany
Pd0055 40555
Brescia, , Italy
Pd0055 40533
Padua, , Italy
Pd0055 40257
Roma, , Italy
Pd0055 40534
Roma, , Italy
Pd0055 40697
Terni, , Italy
Pd0055 40359
Nijmegen, , Netherlands
Pd0055 40694
Bydgoszcz, , Poland
Pd0055 40719
Jelenia Góra, , Poland
Pd0055 40539
Katowice, , Poland
Pd0055 40538
Krakow, , Poland
Pd0055 40696
Krakow, , Poland
Pd0055 40700
Lodz, , Poland
Pd0055 40702
Lublin, , Poland
Pd0055 40535
Oświęcim, , Poland
Pd0055 40536
Warsaw, , Poland
Pd0055 40699
Warsaw, , Poland
Pd0055 40705
Warsaw, , Poland
Pd0055 40045
A Coruña, , Spain
Pd0055 40159
Barcelona, , Spain
Pd0055 40267
Barcelona, , Spain
Pd0055 40046
Córdoba, , Spain
Pd0055 40540
Madrid, , Spain
Pd0055 40542
Móstoles, , Spain
Pd0055 40352
Pamplona, , Spain
Pd0055 40541
San Sebastián, , Spain
Pd0055 40049
Seville, , Spain
Pd0055 40175
London, , United Kingdom
Pd0055 40543
London, , United Kingdom
Pd0055 40698
London, , United Kingdom
Pd0055 40544
Motherwell, , United Kingdom
Pd0055 40306
Newcastle upon Tyne, , United Kingdom
Pd0055 40457
Plymouth, , United Kingdom
Countries
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Other Identifiers
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2022-500424-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1279-2323
Identifier Type: OTHER
Identifier Source: secondary_id
PD0055
Identifier Type: -
Identifier Source: org_study_id
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