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

Parkinson Disease Clinical Trial

— ATLANTIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055985
• Other study ID #: PD0060
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2023
• Est. completion date: December 23, 2024

Study information

• Verified date: June 2024
• Source: UCB Pharma
• Contact: UCB Cares
• Phone: 1-844-599-2273 (USA)
• Email: ucbcares[@]ucb.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 23, 2024
• Est. primary completion date: December 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Placebo
Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.

Drug:
• UCB0022
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.

Locations

Country	Name	City	State
United States	Pd0060 50600	Altamonte Springs	Florida
United States	Pd0060 50110	Ann Arbor	Michigan
United States	Pd0060 50616	Aventura	Florida
United States	Pd0060 50596	Boca Raton	Florida
United States	Pd0060 50615	Boston	Massachusetts
United States	Pd0060 50087	Centerville	Ohio
United States	Pd0060 50609	Charlottesville	Virginia
United States	Pd0060 50622	Cleveland	Ohio
United States	Pd0060 50076	Columbus	Ohio
United States	Pd0060 50402	Crab Orchard	West Virginia
United States	Pd0060 50588	Dallas	Texas
United States	Pd0060 50604	Dayton	Ohio
United States	Pd0060 50578	Decatur	Georgia
United States	Pd0060 50577	Doral	Florida
United States	Pd0060 50598	Englewood	Colorado
United States	Pd0060 50386	Farmington Hills	Michigan
United States	Pd0060 50602	Farmington Hills	Michigan
United States	Pd0060 50519	Fountain Valley	California
United States	Pd0060 50428	Fresno	California
United States	Pd0060 50613	Grand Rapids	Michigan
United States	Pd0060 50143	Henrico	Virginia
United States	Pd0060 50584	Hollywood	Florida
United States	Pd0060 50595	Indianapolis	Indiana
United States	Pd0060 50319	Iowa City	Iowa
United States	Pd0060 50074	Kansas City	Kansas
United States	Pd0060 50292	Kirkland	Washington
United States	Pd0060 50561	Lexington	Kentucky
United States	Pd0060 50608	Little Rock	Arkansas
United States	Pd0060 50589	Los Alamitos	California
United States	Pd0060 50449	Miami	Florida
United States	Pd0060 50579	Miami	Florida
United States	Pd0060 50580	Miami	Florida
United States	Pd0060 50582	Miami	Florida
United States	Pd0060 50597	Naples	Florida
United States	Pd0060 50521	New York	New York
United States	Pd0060 50614	New York	New York
United States	Pd0060 50610	Newark	Delaware
United States	Pd0060 50627	North Dartmouth	Massachusetts
United States	Pd0060 50591	Ocala	Florida
United States	Pd0060 50452	Pasadena	California
United States	Pd0060 50506	Phoenix	Arizona
United States	Pd0060 50605	Port Orange	Florida
United States	Pd0060 50607	Portland	Oregon
United States	Pd0060 50612	Raleigh	North Carolina
United States	Pd0060 50619	Rock Hill	South Carolina
United States	Pd0060 50496	Round Rock	Texas
United States	Pd0060 50620	Saint Petersburg	Florida
United States	Pd0060 50590	Scottsdale	Arizona
United States	Pd0060 50419	Spokane	Washington
United States	Pd0060 50603	Tampa	Florida
United States	Pd0060 50527	Toledo	Ohio
United States	Pd0060 50398	Tulsa	Oklahoma
United States	Pd0060 50624	Vero Beach	Florida
United States	Pd0060 50534	Virginia Beach	Virginia
United States	Pd0060 50585	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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.	From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
Secondary	Incidence of treatment-emergent serious adverse events (SAEs)	A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP).	From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
Secondary	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)
Secondary	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)