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

Last updated: March 27, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Not Recruiting

Phase

2

Condition

Parkinson's Disease

Dyskinesias

Treatment

UCB0599

Minzasolmin (UCB0599)

Clinical Study ID

NCT05543252
PD0055
2022-500424-30-00
U1111-1279-2323
  • Ages 40-78
  • All Genders

Study 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

Inclusion Criteria

  • Participant completed the Treatment Period of PD0053 (NCT04658186). The BaselineVisit for PD0055 (Visit 2) should be no later than 4 weeks following the end oftreatment (EOT) Visit in PD0053 (NCT04658186). Any delay needs to be justified bythe Investigator and approved by the Sponsor

  • A male study participant must agree to use contraception during the Treatment Periodand for at least 90 days after the last dose of the IMP and refrain from donatingsperm during this period.

  • A female study participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies:

◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow thecontraceptive guidance during the Treatment Period and for at least 1 month afterthe last dose of investigational medicinal product (IMP). The study participant musthave a negative urine pregnancy test at Screening (Visit 1), which is to beconfirmed negative by urine testing prior to the first dose of IMP at PD0055Baseline Visit. If oral contraception is used, an additional barrier method will berequired during the study as an IMP-related gastrointestinal upset or a druginteraction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the Informed Consent form (ICF) and in thisprotocol.

Exclusion

Exclusion Criteria:

  • Study participant has any medical or psychiatric condition that, in the opinion ofthe Investigator, could jeopardize or would compromise the study participant'sability to participate in this study

  • A female study participant who tests positive for pregnancy, plans to get pregnantduring 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 cardiacpacemakers, pumps, and implantable cardioverters, will be excluded from usingDigital Health Technology, but may participate in the main study

  • Study participant does not agree to refrain from donating blood or blood products orother body fluids

Study Design

Total Participants: 428
Treatment Group(s): 2
Primary Treatment: UCB0599
Phase: 2
Study Start date:
August 29, 2022
Estimated Completion Date:
April 21, 2025

Connect with a study center

  • Pd0055 50374

    Calgary,
    Canada

    Site Not Available

  • Pd0055 50387

    Ottawa,
    Canada

    Site Not Available

  • Pd0055 50389

    Toronto,
    Canada

    Site Not Available

  • Pd0055 40527

    Bordeaux,
    France

    Site Not Available

  • Pd0055 40424

    Créteil,
    France

    Site Not Available

  • Pd0055 40526

    Lille,
    France

    Site Not Available

  • Pd0055 40130

    Marseille,
    France

    Site Not Available

  • Pd0055 40635

    Nantes,
    France

    Site Not Available

  • Pd0055 40524

    Nimes,
    France

    Site Not Available

  • Pd0055 40525

    Paris,
    France

    Site Not Available

  • Pd0055 40131

    Strasbourg,
    France

    Site Not Available

  • Pd0055 40528

    Toulouse Cedex 09,
    France

    Site Not Available

  • Pd0055 40515

    Berlin,
    Germany

    Site Not Available

  • Pd0055 40138

    Bonn,
    Germany

    Site Not Available

  • Pd0055 40530

    Dresden,
    Germany

    Site Not Available

  • Pd0055 40711

    Erbach,
    Germany

    Site Not Available

  • Pd0055 40023

    Erlangen,
    Germany

    Site Not Available

  • Pd0055 40710

    Essen,
    Germany

    Site Not Available

  • Pd0055 40529

    Giessen,
    Germany

    Site Not Available

  • Pd0055 40532

    Haag in Oberbayern,
    Germany

    Site Not Available

  • Pd0055 40249

    Kiel,
    Germany

    Site Not Available

  • Pd0055 40174

    Mainz,
    Germany

    Site Not Available

  • Pd0055 40529

    Marburg,
    Germany

    Site Not Available

  • Pd0055 40531

    Regensburg,
    Germany

    Site Not Available

  • Pd0055 40555

    Brescia,
    Italy

    Site Not Available

  • Pd0055 40533

    Padova,
    Italy

    Site Not Available

  • Pd0055 40257

    Roma,
    Italy

    Site Not Available

  • Pd0055 40534

    Roma,
    Italy

    Site Not Available

  • Pd0055 40697

    Terni,
    Italy

    Site Not Available

  • Pd0055 40359

    Nijmegen,
    Netherlands

    Site Not Available

  • Pd0055 40694

    Bydgoszcz,
    Poland

    Site Not Available

  • Pd0055 40719

    Jelenia Gora,
    Poland

    Site Not Available

  • Pd0055 40539

    Katowice,
    Poland

    Site Not Available

  • Pd0055 40538

    Krakow,
    Poland

    Site Not Available

  • Pd0055 40696

    Krakow,
    Poland

    Site Not Available

  • Pd0055 40700

    Lodz,
    Poland

    Site Not Available

  • Pd0055 40702

    Lublin,
    Poland

    Site Not Available

  • Pd0055 40535

    Oswiecim,
    Poland

    Site Not Available

  • Pd0055 40536

    Warszawa,
    Poland

    Site Not Available

  • Pd0055 40699

    Warszawa,
    Poland

    Site Not Available

  • Pd0055 40705

    Warszawa,
    Poland

    Site Not Available

  • Pd0055 40045

    A Coruña,
    Spain

    Site Not Available

  • Pd0055 40159

    Barcelona,
    Spain

    Site Not Available

  • Pd0055 40267

    Barcelona,
    Spain

    Site Not Available

  • Pd0055 40046

    Cordoba,
    Spain

    Site Not Available

  • Pd0055 40540

    Madrid,
    Spain

    Site Not Available

  • Pd0055 40542

    Móstoles,
    Spain

    Site Not Available

  • Pd0055 40352

    Pamplona,
    Spain

    Site Not Available

  • Pd0055 40541

    San Sebastián,
    Spain

    Site Not Available

  • Pd0055 40049

    Sevilla,
    Spain

    Site Not Available

  • Pd0055 40175

    London,
    United Kingdom

    Site Not Available

  • Pd0055 40543

    London,
    United Kingdom

    Site Not Available

  • Pd0055 40698

    London,
    United Kingdom

    Site Not Available

  • Pd0055 40544

    Motherwell,
    United Kingdom

    Site Not Available

  • Pd0055 40306

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Pd0055 40457

    Plymouth,
    United Kingdom

    Site Not Available

  • Pd0055 50506

    Phoenix, Arizona 85004-1150
    United States

    Site Not Available

  • Pd0055 50519

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Pd0055 50385

    Fresno, California 93710
    United States

    Site Not Available

  • Pd0055 50118

    Los Angeles, California 90033
    United States

    Site Not Available

  • Pd0055 50531

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Pd0055 50392

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Pd0055 50538

    Farmington, Connecticut 06030-3805
    United States

    Site Not Available

  • Pd0055 50396

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Pd0055 50524

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Pd0055 50394

    Tampa, Florida 33613
    United States

    Site Not Available

  • Pd0055 50544

    Augusta, Georgia 30912-0004
    United States

    Site Not Available

  • Pd0055 50310

    Chicago, Illinois 60612-3863
    United States

    Site Not Available

  • Pd0055 50401

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Pd0055 50399

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Pd0055 50549

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Pd0055 50074

    Kansas City, Kansas 66160-7233
    United States

    Site Not Available

  • Pd0055 50121

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Pd0055 50395

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Pd0055 50547

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Pd0055 50243

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Pd0055 50546

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Pd0055 50386

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Pd0055 50536

    Saint Paul, Minnesota 55130
    United States

    Site Not Available

  • Pd0055 50397

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Pd0055 50530

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Pd0055 50535

    Williamsville, New York 14221
    United States

    Site Not Available

  • Pd0055 50311

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pd0055 50372

    Cleveland, Ohio 44121
    United States

    Site Not Available

  • Pd0055 50255

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Pd0055 50398

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Pd0055 50526

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Pd0055 50084

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Pd0055 50543

    Memphis, Tennessee 38157
    United States

    Site Not Available

  • Pd0055 50113

    Houston, Texas 77030
    United States

    Site Not Available

  • Pd0055 50525

    Houston, Texas 77030
    United States

    Site Not Available

  • Pd0055 50400

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • Pd0055 50107

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Pd0055 50410

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Pd0055 50534

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Pd0055 50292

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Pd0055 50402

    Crab Orchard, West Virginia 25827
    United States

    Site Not Available

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