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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: UCB0022; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 1-844-599-2273 (USA); Email: ucbcares@ucb.com
• Study Contact Backup: Name: UCB Cares; Phone Number: 001 844 599 2273; Email: UCBCares@ucb.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Pd0060 50506
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • Pd0060 50590
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Pd0060 50519
    • Fresno, California, United States, 93710
      • Recruiting
      • Pd0060 50428
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Pd0060 50589
    • Pasadena, California, United States, 91105
      • Recruiting
      • Pd0060 50452
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • Pd0060 50598
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Recruiting
      • Pd0060 50600
    • Aventura, Florida, United States, 33180
      • Recruiting
      • Pd0060 50616
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Pd0060 50596
    • Doral, Florida, United States, 33172
      • Recruiting
      • Pd0060 50577
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Pd0060 50584
    • Miami, Florida, United States, 33176
      • Recruiting
      • Pd0060 50580
    • Miami, Florida, United States, 33125
      • Recruiting
      • Pd0060 50579
    • Miami, Florida, United States, 33133
      • Recruiting
      • Pd0060 50449
    • Miami, Florida, United States, 33122
      • Recruiting
      • Pd0060 50582
    • Naples, Florida, United States, 34105
      • Recruiting
      • Pd0060 50597
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Pd0060 50591
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Pd0060 50605
    • Saint Petersburg, Florida, United States, 33710
      • Recruiting
      • Pd0060 50620
    • Tampa, Florida, United States, 33609
      • Recruiting
      • Pd0060 50603
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Pd0060 50585
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Recruiting
      • Pd0060 50578
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Recruiting
      • Pd0060 50595
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Pd0060 50074
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Pd0060 50615
    • North Dartmouth, Massachusetts, United States, 02747
      • Recruiting
      • Pd0060 50627
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Pd0060 50602
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Pd0060 50386
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Pd0060 50613
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Pd0060 50521
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Pd0060 50612
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • Pd0060 50076
    • Dayton, Ohio, United States, 45449
      • Recruiting
      • Pd0060 50604
    • Toledo, Ohio, United States, 43614
      • Recruiting
      • Pd0060 50527
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Pd0060 50398
  • Oregon
    • Portland, Oregon, United States, 93710
      • Recruiting
      • Pd0060 50607
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Recruiting
      • Pd0060 50619
  • Texas
    • Round Rock, Texas, United States, 78681
      • Recruiting
      • Pd0060 50496
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • Pd0060 50609
    • Henrico, Virginia, United States, 23233
      • Recruiting
      • Pd0060 50143
    • Virginia Beach, Virginia, United States, 23456
      • Recruiting
      • Pd0060 50534
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Pd0060 50419
  • West Virginia
    • Crab Orchard, West Virginia, United States, 25827
      • Recruiting
      • Pd0060 50402

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCB0022-Dose A; Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.	Drug: UCB0022; Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Experimental: UCB0022-Dose B; Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.	Drug: UCB0022; Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Placebo Comparator: Placebo; Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.	Other: Placebo; Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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: 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)
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)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): December 9, 2024
• Study Completion (Estimated): December 23, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson Disease; Phase 2; motor fluctuations; UCB0022; wearing-off
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No