Study Stopped
Based on available data, the decision was made to stop development of UCB0599/minzasolmin as treatment of Parkinson's Disease.
An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease
3 other identifiers
interventional
428
9 countries
96
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2022
CompletedFirst Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedResults Posted
Study results publicly available
April 2, 2026
CompletedApril 2, 2026
March 1, 2026
2.6 years
September 13, 2022
February 3, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Dopamine Transporter Imaging, Measured by Single Photon Emission Computed Tomography (DaT-SPECT), Whole Striatum Specific Binding Ratio up to PD0055 EOT or ET (Corresponding to a Visit Between PD0055 Month 6 and Month 18 Inclusive)
Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit.
From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 Screening
Secondary Outcomes (4)
Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18
From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 Screening
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
Percentage of Participants With Serious TEAEs
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
Percentage of Participants With TEAEs Leading to Withdrawal From the Study
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
Study Arms (2)
Minzasolmin (UCB0599) High Dose Arm
EXPERIMENTALParticipants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.
Minzasolmin (UCB0599) Low Dose Arm
EXPERIMENTALParticipants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Pd0055 50506
Phoenix, Arizona, 85004-1150, United States
Pd0055 50519
Fountain Valley, California, 92708, United States
Pd0055 50385
Fresno, California, 93710, United States
Pd0055 50118
Los Angeles, California, 90033, United States
Pd0055 50531
Englewood, Colorado, 80113, United States
Pd0055 50392
Danbury, Connecticut, 06810, United States
Pd0055 50538
Farmington, Connecticut, 06030-3805, United States
Pd0055 50396
Boca Raton, Florida, 33486, United States
Pd0055 50524
Bradenton, Florida, 34205, United States
Pd0055 50394
Tampa, Florida, 33613, United States
Pd0055 50544
Augusta, Georgia, 30912-0004, United States
Pd0055 50401
Chicago, Illinois, 60611, United States
Pd0055 50310
Chicago, Illinois, 60612-3863, United States
Pd0055 50399
Winfield, Illinois, 60190, United States
Pd0055 50549
Iowa City, Iowa, 52242, United States
Pd0055 50074
Kansas City, Kansas, 66160-8500, United States
Pd0055 50121
Lexington, Kentucky, 40536-0284, United States
Pd0055 50395
New Orleans, Louisiana, 70121, United States
Pd0055 50547
Baltimore, Maryland, 21287, United States
Pd0055 50243
Boston, Massachusetts, 02114, United States
Pd0055 50546
Worcester, Massachusetts, 01655, United States
Pd0055 50386
Farmington Hills, Michigan, 48334, United States
Pd0055 50536
Saint Paul, Minnesota, 55130, United States
Pd0055 50397
Las Vegas, Nevada, 89123, United States
Pd0055 50530
Stony Brook, New York, 11794, United States
Pd0055 50535
Williamsville, New York, 14221, United States
Pd0055 50372
Cleveland, Ohio, 44121, United States
Pd0055 50311
Cleveland, Ohio, 44195, United States
Pd0055 50255
Columbus, Ohio, 43210-1240, United States
Pd0055 50398
Tulsa, Oklahoma, 74136, United States
Pd0055 50084
Charleston, Oregon, 29425, United States
Pd0055 50526
Philadelphia, Pennsylvania, 19107, United States
Pd0055 50543
Memphis, Tennessee, 38157, United States
Pd0055 50113
Houston, Texas, 77030, United States
Pd0055 50525
Houston, Texas, 77030, United States
Pd0055 50400
San Antonio, Texas, 78229-3900, United States
Pd0055 50107
Burlington, Vermont, 05401, United States
Pd0055 50410
Fairfax, Virginia, 22031, United States
Pd0055 50534
Virginia Beach, Virginia, 23456, United States
Pd0055 50292
Kirkland, Washington, 98034, United States
Pd0055 50402
Crab Orchard, West Virginia, 25827, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study PD0055 was terminated early, as the decision was made to stop development of UCB0599/minzasolmin as treatment of Parkinson's Disease.
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 16, 2022
Study Start
August 29, 2022
Primary Completion
March 18, 2025
Study Completion
March 25, 2025
Last Updated
April 2, 2026
Results First Posted
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.