A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
NCT ID: NCT06055985
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2023-11-17
2025-04-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
UCB0022-Dose A
Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.
UCB0022
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
UCB0022-Dose B
Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.
UCB0022
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Placebo
Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.
Placebo
Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.
UCB0022
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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%)
35 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma SRL
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pd0060 50506
Phoenix, Arizona, United States
Pd0060 50590
Scottsdale, Arizona, United States
Pd0060 50608
Little Rock, Arkansas, United States
Pd0060 50519
Fountain Valley, California, United States
Pd0060 50428
Fresno, California, United States
Pd0060 50601
Loma Linda, California, United States
Pd0060 50589
Los Alamitos, California, United States
Pd0060 50587
Los Angeles, California, United States
Pd0060 50452
Pasadena, California, United States
Pd0060 50598
Englewood, Colorado, United States
Pd0060 50628
New Haven, Connecticut, United States
Pd0060 50610
Newark, Delaware, United States
Pd0060 50600
Altamonte Springs, Florida, United States
Pd0060 50616
Aventura, Florida, United States
Pd0060 50596
Boca Raton, Florida, United States
Pd0060 50524
Bradenton, Florida, United States
Pd0060 50647
DeLand, Florida, United States
Pd0060 50577
Doral, Florida, United States
Pd0060 50584
Hollywood, Florida, United States
Pd0060 50582
Miami, Florida, United States
Pd0060 50579
Miami, Florida, United States
Pd0060 50449
Miami, Florida, United States
Pd0060 50580
Miami, Florida, United States
Pd0060 50597
Naples, Florida, United States
Pd0060 50591
Ocala, Florida, United States
Pd0060 50605
Port Orange, Florida, United States
Pd0060 50620
St. Petersburg, Florida, United States
Pd0060 50603
Tampa, Florida, United States
Pd0060 50585
Winter Park, Florida, United States
Pd0060 50075
Augusta, Georgia, United States
Pd0060 50595
Indianapolis, Indiana, United States
Pd0060 50319
Iowa City, Iowa, United States
Pd0060 50074
Kansas City, Kansas, United States
Pd0060 50561
Lexington, Kentucky, United States
Pd0060 50615
Boston, Massachusetts, United States
Pd0060 50085
Boston, Massachusetts, United States
Pd0060 50627
North Dartmouth, Massachusetts, United States
Pd0060 50110
Ann Arbor, Michigan, United States
Pd0060 50545
East Lansing, Michigan, United States
Pd0060 50386
Farmington Hills, Michigan, United States
Pd0060 50613
Grand Rapids, Michigan, United States
Pd0060 50614
New York, New York, United States
Pd0060 50521
New York, New York, United States
Pd0060 50612
Raleigh, North Carolina, United States
Pd0060 50087
Centerville, Ohio, United States
Pd0060 50622
Cleveland, Ohio, United States
Pd0060 50076
Columbus, Ohio, United States
Pd0060 50604
Dayton, Ohio, United States
Pd0060 50527
Toledo, Ohio, United States
Pd0060 50398
Tulsa, Oklahoma, United States
Pd0060 50607
Portland, Oregon, United States
Pd0060 50619
Rock Hill, South Carolina, United States
Pd0060 50496
Round Rock, Texas, United States
Pd0060 50568
San Antonio, Texas, United States
Pd0060 50537
Salt Lake City, Utah, United States
Pd0060 50143
Henrico, Virginia, United States
Pd0060 50534
Virginia Beach, Virginia, United States
Pd0060 50440
Bellevue, Washington, United States
Pd0060 50292
Kirkland, Washington, United States
Pd0060 50419
Spokane, Washington, United States
Pd0060 50402
Crab Orchard, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PD0060
Identifier Type: -
Identifier Source: org_study_id