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

Purpose

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).

Condition

  • Parkinson Disease

Eligibility

Eligible Ages
Between 35 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Study participant must be 35 to 80 years of age (inclusive) at the time of signing the informed consent form (ICF) - Study participant is diagnosed with Parkinson's disease (PD) (based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at the Screening Visit) and diagnosed ≥5 years before the Screening Visit (based on historical 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 differentiate between the ON and OFF states - Study participant is responsive to levodopa and currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data) - Study participant has disease severity Stages I-III (modified Hoehn and Yahr staging) during ON state - Study participant agrees to not post personal medical data or information related to the 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 Treatment Period and for at least 2 weeks after the last dose of study treatment and refrain from donating sperm during this period 2. A female study participant must not be a woman of childbearing potential (WOCBP)

Exclusion Criteria

  • Study participant is diagnosed with any form of Parkinsonism other than idiopathic PD (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 by Movement 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 other psychiatric condition within the past 5 years, that, as per investigator opinion, could jeopardize or would compromise the study participant's ability to participate in 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 hypertensive encephalopathy, unless the underlying cause was unequivocally identified and has been removed - Study participant has orthostatic hypotension requiring medication or a current history of "clinically significant" orthostatic hypotension as per the investigator's opinion (eg, recurrent orthostatic presyncope or syncope) - Study participant has a history over the past 12 months or between the Screening and Baseline 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor and CRO staff is blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UCB0022-Dose A 		Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.
  • Drug: UCB0022
    Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Experimental
UCB0022-Dose B 		Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.
  • Drug: UCB0022
    Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Placebo Comparator
Placebo 		Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.
  • Other: Placebo
    Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.

Recruiting Locations

Pd0060 50506
Phoenix, Arizona 85004

Pd0060 50590
Scottsdale, Arizona 85258

Pd0060 50608
Little Rock, Arkansas 72205

Pd0060 50519
Fountain Valley, California 92708

Pd0060 50428
Fresno, California 93710

Pd0060 50601
Loma Linda, California 92354

Pd0060 50589
Los Alamitos, California 90720

Pd0060 50452
Pasadena, California 91105

Pd0060 50598
Englewood, Colorado 80113

Pd0060 50610
Newark, Delaware 19713

Pd0060 50600
Altamonte Springs, Florida 32714

Pd0060 50616
Aventura, Florida 33180

Pd0060 50596
Boca Raton, Florida 33486

Pd0060 50577
Doral, Florida 33172

Pd0060 50584
Hollywood, Florida 33021

Pd0060 50582
Miami, Florida 33122

Pd0060 50579
Miami, Florida 33125

Pd0060 50449
Miami, Florida 33133

Pd0060 50580
Miami, Florida 33176

Pd0060 50597
Naples, Florida 34105

Pd0060 50591
Ocala, Florida 34470

Pd0060 50605
Port Orange, Florida 32127

Pd0060 50620
Saint Petersburg, Florida 33710

Pd0060 50603
Tampa, Florida 33609

Pd0060 50624
Vero Beach, Florida 32960

Pd0060 50585
Winter Park, Florida 32789

Pd0060 50075
Augusta, Georgia 30912

Pd0060 50578
Decatur, Georgia 30033

Pd0060 50595
Indianapolis, Indiana 46256

Pd0060 50319
Iowa City, Iowa 52242

Pd0060 50074
Kansas City, Kansas 66160

Pd0060 50561
Lexington, Kentucky 40536-0284

Pd0060 50615
Boston, Massachusetts 02118

Pd0060 50627
North Dartmouth, Massachusetts 02747

Pd0060 50110
Ann Arbor, Michigan 48109-0944

Pd0060 50545
East Lansing, Michigan 48824

Pd0060 50386
Farmington Hills, Michigan 48334

Pd0060 50602
Farmington Hills, Michigan 48334

Pd0060 50613
Grand Rapids, Michigan 49503

Pd0060 50621
Albuquerque, New Mexico 87106

Pd0060 50614
New York, New York 10021

Pd0060 50521
New York, New York 10029

Pd0060 50612
Raleigh, North Carolina 27607

Pd0060 50087
Centerville, Ohio 45459

Pd0060 50622
Cleveland, Ohio 44195

Pd0060 50076
Columbus, Ohio 43221

Pd0060 50604
Dayton, Ohio 45449

Pd0060 50527
Toledo, Ohio 43614

Pd0060 50398
Tulsa, Oklahoma 74136

Pd0060 50607
Portland, Oregon 93710

Pd0060 50619
Rock Hill, South Carolina 29732

Pd0060 50588
Dallas, Texas 75243-1188

Pd0060 50496
Round Rock, Texas 78681

Pd0060 50609
Charlottesville, Virginia 22903

Pd0060 50143
Henrico, Virginia 23233

Pd0060 50534
Virginia Beach, Virginia 23456

Pd0060 50292
Kirkland, Washington 98034

Pd0060 50419
Spokane, Washington 99202

Pd0060 50402
Crab Orchard, West Virginia 25827

More Details

NCT ID
NCT06055985
Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
1-844-599-2273 (USA)
ucbcares@ucb.com