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

• ClinicalTrials.gov Identifier: NCT06055985
• Recruitment Status: Recruiting
• First Posted: September 28, 2023
• Last Update Posted: May 20, 2024
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Tracking Information

• First Submitted Date: September 20, 2023
• First Posted Date: September 28, 2023
• Last Update Posted Date: May 20, 2024
• Actual Study Start Date: November 17, 2023
• Estimated Primary Completion Date: December 9, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2023)

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 [ Time Frame: From Baseline (Day 1) to Visit 9 (Day 70) ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 20, 2023)

• Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) ]
  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) [ Time Frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) ]
  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 [ Time Frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12) ]
  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) [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Sponsor and CRO staff is blinded.

Primary Purpose: Treatment

• Condition: 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.

Study Arms

• Experimental: UCB0022-Dose A
  Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.
  Intervention: Drug: UCB0022
• Experimental: UCB0022-Dose B
  Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.
  Intervention: Drug: UCB0022
• Placebo Comparator: Placebo
  Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 20, 2023): 189
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 23, 2024
• Estimated Primary Completion Date: December 9, 2024 (Final data collection date for primary outcome measure)

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:

  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%)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: UCB Cares; 1-844-599-2273 (USA); ucbcares@ucb.com

Contact: UCB Cares; 001 844 599 2273; ucbcares@ucb.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06055985
• Other Study ID Numbers: PD0060
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• 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.
• 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
• URL: http://vivli.org

• Current Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• Original Responsible Party: Same as current
• Current Study Sponsor: UCB Biopharma SRL
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; 001 844 599 2273

• PRS Account: UCB Pharma
• Verification Date: May 2024