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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
UCB0022
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Phase 2, UCB0022, wearing-off, motor fluctuations

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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) 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%)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    UCB0022-Dose A

    UCB0022-Dose B

    Placebo

    Arm Description

    Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.

    Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.

    Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).
    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.
    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.

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    October 23, 2023
    Sponsor
    UCB Biopharma SRL
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06055985
    Brief Title
    A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 21, 2023 (Anticipated)
    Primary Completion Date
    November 4, 2024 (Anticipated)
    Study Completion Date
    November 18, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Biopharma SRL

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson Disease, Phase 2, UCB0022, wearing-off, motor fluctuations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Sponsor and CRO staff is blinded.
    Allocation
    Randomized
    Enrollment
    189 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UCB0022-Dose A
    Arm Type
    Experimental
    Arm Description
    Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.
    Arm Title
    UCB0022-Dose B
    Arm Type
    Experimental
    Arm Description
    Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.
    Intervention Type
    Drug
    Intervention Name(s)
    UCB0022
    Intervention Description
    Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    From Baseline (Day 1) to Visit 9 (Day 70)
    Secondary Outcome Measure Information:
    Title
    Incidence of treatment-emergent adverse events (TEAEs)
    Description
    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.
    Time Frame
    From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
    Title
    Incidence of treatment-emergent serious adverse events (SAEs)
    Description
    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).
    Time Frame
    From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
    Title
    Incidence of TEAEs leading to withdrawal from the study
    Description
    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.
    Time Frame
    From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
    Title
    Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)
    Description
    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.
    Time Frame
    at Visit 9 (Day 70)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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) 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%)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    UCB Cares
    Phone
    1-844-599-2273 (USA)
    Email
    ucbcares@ucb.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    UCB Cares
    Phone
    001 844 599 2273
    Email
    ucbcares@ucb.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Cares
    Organizational Affiliation
    001 844 599 2273
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    http://vivli.org

    Learn more about this trial

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

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