An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

March 13, 2026 updated by: UCB Biopharma SRL

A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

428

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Pd0055 50374
      • Ottawa, Canada
        • Pd0055 50387
      • Toronto, Canada
        • Pd0055 50389
  • France
      • Bordeaux, France
        • Pd0055 40527
      • Créteil, France
        • Pd0055 40424
      • Lille, France
        • Pd0055 40526
      • Marseille, France
        • Pd0055 40130
      • Nantes, France
        • Pd0055 40635
      • Nîmes, France
        • Pd0055 40524
      • Paris, France
        • Pd0055 40525
      • Strasbourg, France
        • Pd0055 40131
      • Toulouse, France
        • Pd0055 40528
  • Germany
      • Berlin, Germany
        • Pd0055 40515
      • Bonn, Germany
        • Pd0055 40138
      • Dresden, Germany
        • Pd0055 40530
      • Erbach im Odenwald, Germany
        • Pd0055 40711
      • Erlangen, Germany
        • Pd0055 40023
      • Essen, Germany
        • Pd0055 40710
      • Haag in Oberbayern, Germany
        • Pd0055 40532
      • Kiel, Germany
        • Pd0055 40249
      • Mainz, Germany
        • Pd0055 40174
      • Marburg, Germany
        • Pd0055 40529
      • Regensburg, Germany
        • Pd0055 40531
  • Italy
      • Brescia, Italy
        • Pd0055 40555
      • Padova, Italy
        • Pd0055 40533
      • Roma, Italy
        • Pd0055 40534
      • Roma, Italy
        • Pd0055 40257
      • Terni, Italy
        • Pd0055 40697
  • Netherlands
      • Nijmegen, Netherlands
        • Pd0055 40359
  • Poland
      • Bydgoszcz, Poland
        • Pd0055 40694
      • Jelenia Góra, Poland
        • Pd0055 40719
      • Katowice, Poland
        • Pd0055 40539
      • Krakow, Poland
        • Pd0055 40538
      • Krakow, Poland
        • Pd0055 40696
      • Lodz, Poland
        • Pd0055 40700
      • Lublin, Poland
        • Pd0055 40702
      • Oświęcim, Poland
        • Pd0055 40535
      • Warsaw, Poland
        • Pd0055 40536
      • Warsaw, Poland
        • Pd0055 40699
      • Warsaw, Poland
        • Pd0055 40705
  • Spain
      • A Coruña, Spain
        • Pd0055 40045
      • Barcelona, Spain
        • Pd0055 40159
      • Barcelona, Spain
        • Pd0055 40267
      • Córdoba, Spain
        • Pd0055 40046
      • Madrid, Spain
        • Pd0055 40540
      • Móstoles, Spain
        • Pd0055 40542
      • Pamplona, Spain
        • Pd0055 40352
      • San Sebastián, Spain
        • Pd0055 40541
      • Seville, Spain
        • Pd0055 40049
  • United Kingdom
      • London, United Kingdom
        • Pd0055 40175
      • London, United Kingdom
        • Pd0055 40698
      • London, United Kingdom
        • Pd0055 40543
      • Motherwell, United Kingdom
        • Pd0055 40544
      • Newcastle upon Tyne, United Kingdom
        • Pd0055 40306
      • Plymouth, United Kingdom
        • Pd0055 40457
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004-1150
        • Pd0055 50506
    • California
      • Fountain Valley, California, United States, 92708
        • Pd0055 50519
      • Fresno, California, United States, 93710
        • Pd0055 50385
      • Los Angeles, California, United States, 90033
        • Pd0055 50118
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Pd0055 50531
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Pd0055 50392
      • Farmington, Connecticut, United States, 06030-3805
        • Pd0055 50538
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Pd0055 50396
      • Bradenton, Florida, United States, 34205
        • Pd0055 50524
      • Tampa, Florida, United States, 33613
        • Pd0055 50394
    • Georgia
      • Augusta, Georgia, United States, 30912-0004
        • Pd0055 50544
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pd0055 50401
      • Chicago, Illinois, United States, 60612-3863
        • Pd0055 50310
      • Winfield, Illinois, United States, 60190
        • Pd0055 50399
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pd0055 50549
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Pd0055 50074
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • Pd0055 50121
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Pd0055 50395
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Pd0055 50547
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pd0055 50243
      • Worcester, Massachusetts, United States, 01655
        • Pd0055 50546
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Pd0055 50386
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • Pd0055 50536
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Pd0055 50397
    • New York
      • Stony Brook, New York, United States, 11794
        • Pd0055 50530
      • Williamsville, New York, United States, 14221
        • Pd0055 50535
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • Pd0055 50372
      • Cleveland, Ohio, United States, 44195
        • Pd0055 50311
      • Columbus, Ohio, United States, 43210-1240
        • Pd0055 50255
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Pd0055 50398
    • Oregon
      • Charleston, Oregon, United States, 29425
        • Pd0055 50084
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pd0055 50526
    • Tennessee
      • Memphis, Tennessee, United States, 38157
        • Pd0055 50543
    • Texas
      • Houston, Texas, United States, 77030
        • Pd0055 50113
      • Houston, Texas, United States, 77030
        • Pd0055 50525
      • San Antonio, Texas, United States, 78229-3900
        • Pd0055 50400
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pd0055 50107
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Pd0055 50410
      • Virginia Beach, Virginia, United States, 23456
        • Pd0055 50534
    • Washington
      • Kirkland, Washington, United States, 98034
        • Pd0055 50292
    • West Virginia
      • Crab Orchard, West Virginia, United States, 25827
        • Pd0055 50402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minzasolmin (UCB0599) High Dose Arm
Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.
Drug: 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.
Experimental: Minzasolmin (UCB0599) Low Dose Arm
Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18
Time Frame: From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 Screening
The Cumulative Levodopa Equivalent Daily Dose (LEDD) was calculated for each participant at each visit, based on the dose level and frequency indicated on the concomitant medication form and at the end of study. This was the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) were accounted for when calculating cumulative doses.
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)
Time Frame: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
Percentage of Participants With Serious TEAEs
Time Frame: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, and other important medical events which are based on medical or scientific judgement may jeopardise the participant's life, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.
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
Time Frame: 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 are presented. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.
From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Actual)

March 18, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD0055
  • 2022-500424-30-00 (Registry Identifier: EU CT Number)
  • U1111-1279-2323 (Other Identifier: Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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