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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0022-Dose A | Experimental | Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period. |
|
| UCB0022-Dose B | Experimental | Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period. |
|
| Placebo | Placebo Comparator | Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Study participants will receive placebo orally administered as tablet at pre-specified time points during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days | The Hauser Parkinson's disease (PD) symptoms diary is a study participant-completed diary that records the daily ON time and OFF time of study participants with PD with motor fluctuations and dyskinesia. | From Baseline (Day 1) to Visit 9 (Day 70) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pd0060 50506 | Phoenix | Arizona | 85004 | United States | ||
| Pd0060 50590 |
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal
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Sponsor and CRO staff is blinded.
| UCB0022 | Drug | Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period. |
|
| From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) |
| Incidence of treatment-emergent serious adverse events (SAEs) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
| From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) |
| Incidence of TEAEs leading to withdrawal from the study | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose. | From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) |
| Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70) | Ctrough: The predose observed plasma concentration (average, per visit) will be plotted and depicted graphically to assess trajectory to steady-state for parent and active metabolites. | at Visit 9 (Day 70) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Pd0060 50608 | Little Rock | Arkansas | 72205 | United States |
| Pd0060 50519 | Fountain Valley | California | 92708 | United States |
| Pd0060 50428 | Fresno | California | 93710 | United States |
| Pd0060 50601 | Loma Linda | California | 92354 | United States |
| Pd0060 50589 | Los Alamitos | California | 90720 | United States |
| Pd0060 50587 | Los Angeles | California | 90033 | United States |
| Pd0060 50452 | Pasadena | California | 91106 | United States |
| Pd0060 50598 | Englewood | Colorado | 80113 | United States |
| Pd0060 50628 | New Haven | Connecticut | 06519 | United States |
| Pd0060 50610 | Newark | Delaware | 19713 | United States |
| Pd0060 50600 | Altamonte Springs | Florida | 32714 | United States |
| Pd0060 50616 | Aventura | Florida | 33180 | United States |
| Pd0060 50596 | Boca Raton | Florida | 33486 | United States |
| Pd0060 50524 | Bradenton | Florida | 34205 | United States |
| Pd0060 50647 | DeLand | Florida | 32720 | United States |
| Pd0060 50577 | Doral | Florida | 33172 | United States |
| Pd0060 50584 | Hollywood | Florida | 33021 | United States |
| Pd0060 50582 | Miami | Florida | 33122 | United States |
| Pd0060 50579 | Miami | Florida | 33125 | United States |
| Pd0060 50449 | Miami | Florida | 33133 | United States |
| Pd0060 50580 | Miami | Florida | 33176 | United States |
| Pd0060 50597 | Naples | Florida | 34105 | United States |
| Pd0060 50591 | Ocala | Florida | 34470 | United States |
| Pd0060 50605 | Port Orange | Florida | 32127 | United States |
| Pd0060 50620 | St. Petersburg | Florida | 33710 | United States |
| Pd0060 50603 | Tampa | Florida | 33609 | United States |
| Pd0060 50585 | Winter Park | Florida | 32789 | United States |
| Pd0060 50075 | Augusta | Georgia | 30912 | United States |
| Pd0060 50595 | Indianapolis | Indiana | 46256 | United States |
| Pd0060 50319 | Iowa City | Iowa | 52242 | United States |
| Pd0060 50074 | Kansas City | Kansas | 66160 | United States |
| Pd0060 50561 | Lexington | Kentucky | 40536-0284 | United States |
| Pd0060 50615 | Boston | Massachusetts | 02118 | United States |
| Pd0060 50085 | Boston | Massachusetts | 02215 | United States |
| Pd0060 50627 | North Dartmouth | Massachusetts | 02747 | United States |
| Pd0060 50110 | Ann Arbor | Michigan | 48109-0944 | United States |
| Pd0060 50545 | East Lansing | Michigan | 48824 | United States |
| Pd0060 50386 | Farmington Hills | Michigan | 48334 | United States |
| Pd0060 50613 | Grand Rapids | Michigan | 49503 | United States |
| Pd0060 50614 | New York | New York | 10021 | United States |
| Pd0060 50521 | New York | New York | 10029 | United States |
| Pd0060 50612 | Raleigh | North Carolina | 27607 | United States |
| Pd0060 50087 | Centerville | Ohio | 45459 | United States |
| Pd0060 50622 | Cleveland | Ohio | 44195 | United States |
| Pd0060 50076 | Columbus | Ohio | 43221 | United States |
| Pd0060 50604 | Dayton | Ohio | 45449 | United States |
| Pd0060 50527 | Toledo | Ohio | 43614 | United States |
| Pd0060 50398 | Tulsa | Oklahoma | 74136 | United States |
| Pd0060 50607 | Portland | Oregon | 97210 | United States |
| Pd0060 50619 | Rock Hill | South Carolina | 29732 | United States |
| Pd0060 50496 | Round Rock | Texas | 78681 | United States |
| Pd0060 50568 | San Antonio | Texas | 78229 | United States |
| Pd0060 50537 | Salt Lake City | Utah | 84108 | United States |
| Pd0060 50143 | Henrico | Virginia | 23233 | United States |
| Pd0060 50534 | Virginia Beach | Virginia | 23456 | United States |
| Pd0060 50440 | Bellevue | Washington | 98004 | United States |
| Pd0060 50292 | Kirkland | Washington | 98034 | United States |
| Pd0060 50419 | Spokane | Washington | 99202 | United States |
| Pd0060 50402 | Crab Orchard | West Virginia | 25827 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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