NCT06055985CompletedPhase 2
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
A Multicenter Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 20 Sept 2023
- Start date
- Nov 2023
- Primary completion date
- Mar 2025
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Parkinson disease
- NCT number
- NCT06055985
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 207
- From Nov 2023 to the primary completion date, Mar 2025
- 61 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- 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%)
Other
- Study participant is diagnosed with any form of Parkinsonism other than idiopathic PD (eg, atypical or secondary Parkinsonism)
Who the study is looking for
- Study participant must be 35 to 85 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:
- 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
- A female study participant must not be a woman of childbearing potential (WOCBP)
Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pd0060 50600 Coordinator of this site? Confirm its status | Altamonte Springs | United States | Unknown status |
| Pd0060 50110 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Pd0060 50075 Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Pd0060 50616 Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Pd0060 50440 Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Pd0060 50596 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Pd0060 50085 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Pd0060 50615 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Pd0060 50524 Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| Pd0060 50087 Coordinator of this site? Confirm its status | Centerville | United States | Unknown status |
| Pd0060 50622 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Pd0060 50076 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Pd0060 50402 Coordinator of this site? Confirm its status | Crab Orchard | United States | Unknown status |
| Pd0060 50604 Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Pd0060 50647 Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| Pd0060 50577 Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Pd0060 50545 Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| Pd0060 50598 Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Pd0060 50386 Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Pd0060 50519 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Pd0060 50428 Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Pd0060 50613 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Pd0060 50143 Coordinator of this site? Confirm its status | Henrico | United States | Unknown status |
| Pd0060 50584 Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Pd0060 50595 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Pd0060 50319 Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Pd0060 50074 Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Pd0060 50292 Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| Pd0060 50561 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Pd0060 50608 Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Pd0060 50601 Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Pd0060 50589 Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Pd0060 50587 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Pd0060 50580 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pd0060 50582 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pd0060 50579 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pd0060 50449 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pd0060 50597 Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Pd0060 50610 Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Pd0060 50628 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Pd0060 50614 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Pd0060 50521 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Pd0060 50627 Coordinator of this site? Confirm its status | North Dartmouth | United States | Unknown status |
| Pd0060 50591 Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Pd0060 50452 Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Pd0060 50506 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Pd0060 50607 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Pd0060 50605 Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Pd0060 50612 Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Pd0060 50619 Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
| Pd0060 50496 Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Pd0060 50537 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Pd0060 50568 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Pd0060 50590 Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Pd0060 50419 Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Pd0060 50620 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Pd0060 50603 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Pd0060 50527 Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Pd0060 50398 Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Pd0060 50534 Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| Pd0060 50585 Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.