Clinical trial NCT06055985: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Phase 2
UCB0022
wearing-off
motor fluctuations
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 207
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

  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%)

Primary outcomes:
measure: 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
timeFrame: From Baseline (Day 1) to Visit 9 (Day 70)
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
measure: Incidence of treatment-emergent serious adverse events (SAEs)
timeFrame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
measure: Incidence of TEAEs leading to withdrawal from the study
timeFrame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
measure: Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)
timeFrame: at Visit 9 (Day 70)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pd0060 50506
state: Arizona
city: Scottsdale
country: United States
facility: Pd0060 50590
state: Arizona
city: Little Rock
country: United States
facility: Pd0060 50608
state: Arkansas
city: Fountain Valley
country: United States
facility: Pd0060 50519
state: California
city: Fresno
country: United States
facility: Pd0060 50428
state: California
city: Loma Linda
country: United States
facility: Pd0060 50601
state: California
city: Los Alamitos
country: United States
facility: Pd0060 50589
state: California
city: Los Angeles
country: United States
facility: Pd0060 50587
state: California
city: Pasadena
country: United States
facility: Pd0060 50452
state: California
city: Englewood
country: United States
facility: Pd0060 50598
state: Colorado
city: New Haven
country: United States
facility: Pd0060 50628
state: Connecticut
city: Newark
country: United States
facility: Pd0060 50610
state: Delaware
city: Altamonte Springs
country: United States
facility: Pd0060 50600
state: Florida
city: Aventura
country: United States
facility: Pd0060 50616
state: Florida
city: Boca Raton
country: United States
facility: Pd0060 50596
state: Florida
city: Bradenton
country: United States
facility: Pd0060 50524
state: Florida
city: DeLand
country: United States
facility: Pd0060 50647
state: Florida
city: Doral
country: United States
facility: Pd0060 50577
state: Florida
city: Hollywood
country: United States
facility: Pd0060 50584
state: Florida
city: Miami
country: United States
facility: Pd0060 50582
state: Florida
city: Miami
country: United States
facility: Pd0060 50579
state: Florida
city: Miami
country: United States
facility: Pd0060 50449
state: Florida
city: Miami
country: United States
facility: Pd0060 50580
state: Florida
city: Naples
country: United States
facility: Pd0060 50597
state: Florida
city: Ocala
country: United States
facility: Pd0060 50591
state: Florida
city: Port Orange
country: United States
facility: Pd0060 50605
state: Florida
city: Saint Petersburg
country: United States
facility: Pd0060 50620
state: Florida
city: Tampa
country: United States
facility: Pd0060 50603
state: Florida
city: Winter Park
country: United States
facility: Pd0060 50585
state: Florida
city: Augusta
country: United States
facility: Pd0060 50075
state: Georgia
city: Indianapolis
country: United States
facility: Pd0060 50595
state: Indiana
city: Iowa City
country: United States
facility: Pd0060 50319
state: Iowa
city: Kansas City
country: United States
facility: Pd0060 50074
state: Kansas
city: Lexington
country: United States
facility: Pd0060 50561
state: Kentucky
city: Boston
country: United States
facility: Pd0060 50615
state: Massachusetts
city: Boston
country: United States
facility: Pd0060 50085
state: Massachusetts
city: North Dartmouth
country: United States
facility: Pd0060 50627
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pd0060 50110
state: Michigan
city: East Lansing
country: United States
facility: Pd0060 50545
state: Michigan
city: Farmington Hills
country: United States
facility: Pd0060 50386
state: Michigan
city: Grand Rapids
country: United States
facility: Pd0060 50613
state: Michigan
city: New York
country: United States
facility: Pd0060 50614
state: New York
city: New York
country: United States
facility: Pd0060 50521
state: New York
city: Raleigh
country: United States
facility: Pd0060 50612
state: North Carolina
city: Centerville
country: United States
facility: Pd0060 50087
state: Ohio
city: Cleveland
country: United States
facility: Pd0060 50622
state: Ohio
city: Columbus
country: United States
facility: Pd0060 50076
state: Ohio
city: Dayton
country: United States
facility: Pd0060 50604
state: Ohio
city: Toledo
country: United States
facility: Pd0060 50527
state: Ohio
city: Tulsa
country: United States
facility: Pd0060 50398
state: Oklahoma
city: Portland
country: United States
facility: Pd0060 50607
state: Oregon
city: Rock Hill
country: United States
facility: Pd0060 50619
state: South Carolina
city: Round Rock
country: United States
facility: Pd0060 50496
state: Texas
city: San Antonio
country: United States
facility: Pd0060 50568
state: Texas
city: Salt Lake City
country: United States
facility: Pd0060 50537
state: Utah
city: Henrico
country: United States
facility: Pd0060 50143
state: Virginia
city: Virginia Beach
country: United States
facility: Pd0060 50534
state: Virginia
city: Bellevue
country: United States
facility: Pd0060 50440
state: Washington
city: Kirkland
country: United States
facility: Pd0060 50292
state: Washington
city: Spokane
country: United States
facility: Pd0060 50419
state: Washington
city: Crab Orchard
country: United States
facility: Pd0060 50402
state: West Virginia
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: