A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

Last updated: April 17, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Placebo

UCB0022

Clinical Study ID

NCT06055985
PD0060
  • Ages 35-85
  • All Genders

Study Summary

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson's Disease (PD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participant must be 35 to 85 years of age (inclusive) at the time of signingthe informed consent form (ICF)

  • Study participant is diagnosed with Parkinson's disease (PD) (based on the UnitedKingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at theScreening Visit) and diagnosed ≥5 years before the Screening Visit (based onhistorical medical- information documented by the investigator)

  • Study participant has significant daily motor fluctuations

  • Study participant is able to complete a Hauser PD symptoms diary and differentiatebetween the ON and OFF states

  • Study participant is responsive to levodopa and currently receiving treatment withoral daily doses of levodopa combination (levodopa/carbidopa orlevodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data)

  • Study participant has disease severity Stages I-III (modified Hoehn and Yahrstaging) during ON state

  • Study participant agrees to not post personal medical data or information related tothe study on social media until study completion

  • Study participant has body weight ≥45 kg and body mass index within 18 to 30 kg/m^2 (inclusive)

  • Study participant may be male or female:

  1. A male study participant must agree to use contraception during the TreatmentPeriod and for at least 2 weeks after the last dose of study treatment andrefrain from donating sperm during this period

  2. A female study participant must not be a woman of childbearing potential (WOCBP)

Exclusion

Exclusion Criteria:

  • Study participant is diagnosed with any form of Parkinsonism other than idiopathicPD (eg, atypical or secondary Parkinsonism)

  • Study participant is diagnosed with dementia or has important cognitive dysfunction,as determined by Montreal Cognitive Assessment (MoCA) <23 at screening

  • Study participant has a history of neurosurgical intervention for PD (including DBS,thalamotomy, and experimental cell therapy or gene therapy)

  • Participant has a severe peak dose or biphasic dyskinesia at screening, defined byMovement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) items 4.2 score 4 or as per investigator opinion

  • Participant has a history of major depression or psychotic disorder or any otherpsychiatric condition within the past 5 years, that, as per investigator opinion,could jeopardize or would compromise the study participant's ability to participatein the study

  • Study participant has a history of narrow angle glaucoma

  • Study participant has a history of melanoma

  • Study participant has current untreated hypertension

  • Study participant has a history of hypertensive crisis and/or hypertensiveencephalopathy, unless the underlying cause was unequivocally identified and hasbeen removed

  • Study participant has orthostatic hypotension requiring medication or a currenthistory of "clinically significant" orthostatic hypotension as per theinvestigator's opinion (eg, recurrent orthostatic presyncope or syncope)

  • Study participant has a history over the past 12 months or between the Screening andBaseline Visits of any clinically significant arrythmia, myocardial infarction,stroke, transient ischemic attack, moderate or severe congestive heart failure (either New York Heart Association Class III or IV or known ejection fraction <40%)

Study Design

Total Participants: 207
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 17, 2023
Estimated Completion Date:
April 11, 2025

Connect with a study center

  • Pd0060 50506

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Pd0060 50590

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Pd0060 50608

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Pd0060 50519

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Pd0060 50428

    Fresno, California 93710
    United States

    Site Not Available

  • Pd0060 50601

    Loma Linda, California 92354
    United States

    Site Not Available

  • Pd0060 50589

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Pd0060 50587

    Los Angeles, California 90033
    United States

    Site Not Available

  • Pd0060 50452

    Pasadena, California 91106
    United States

    Site Not Available

  • Pd0060 50598

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Pd0060 50628

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Pd0060 50610

    Newark, Delaware 19713
    United States

    Site Not Available

  • Pd0060 50600

    Altamonte Springs, Florida 32714
    United States

    Site Not Available

  • Pd0060 50616

    Aventura, Florida 33180
    United States

    Site Not Available

  • Pd0060 50596

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Pd0060 50524

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Pd0060 50647

    DeLand, Florida 32720
    United States

    Site Not Available

  • Pd0060 50577

    Doral, Florida 33172
    United States

    Site Not Available

  • Pd0060 50584

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Pd0060 50449

    Miami, Florida 33133
    United States

    Site Not Available

  • Pd0060 50579

    Miami, Florida 33125
    United States

    Site Not Available

  • Pd0060 50580

    Miami, Florida 33176
    United States

    Site Not Available

  • Pd0060 50582

    Miami, Florida 33122
    United States

    Site Not Available

  • Pd0060 50597

    Naples, Florida 34105
    United States

    Site Not Available

  • Pd0060 50591

    Ocala, Florida 34470
    United States

    Site Not Available

  • Pd0060 50605

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Pd0060 50620

    Saint Petersburg, Florida 33710
    United States

    Site Not Available

  • Pd0060 50603

    Tampa, Florida 33609
    United States

    Site Not Available

  • Pd0060 50624

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Pd0060 50585

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Pd0060 50075

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Pd0060 50578

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Pd0060 50595

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Pd0060 50319

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Pd0060 50074

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Pd0060 50561

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Pd0060 50586

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Pd0060 50085

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Pd0060 50615

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Pd0060 50627

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Pd0060 50110

    Ann Arbor, Michigan 48109-0944
    United States

    Site Not Available

  • Pd0060 50545

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Pd0060 50386

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Pd0060 50602

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Pd0060 50613

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Pd0060 50611

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Pd0060 50621

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Pd0060 50521

    New York, New York 10029
    United States

    Site Not Available

  • Pd0060 50614

    New York, New York 10021
    United States

    Site Not Available

  • Pd0060 50612

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Pd0060 50087

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Pd0060 50622

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pd0060 50076

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Pd0060 50604

    Dayton, Ohio 45449
    United States

    Site Not Available

  • Pd0060 50527

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Pd0060 50398

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Pd0060 50607

    Portland, Oregon 97210
    United States

    Site Not Available

  • Pd0060 50619

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Pd0060 50588

    Dallas, Texas 75243-1188
    United States

    Site Not Available

  • Pd0060 50496

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Pd0060 50568

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Pd0060 50537

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Pd0060 50609

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Pd0060 50143

    Henrico, Virginia 23233
    United States

    Site Not Available

  • Pd0060 50534

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Pd0060 50440

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Pd0060 50292

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Pd0060 50419

    Spokane, Washington 99202
    United States

    Site Not Available

  • Pd0060 50402

    Crab Orchard, West Virginia 25827
    United States

    Site Not Available

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