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

UCB

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Other: Placebo; Drug: UCB0022

Study type: Interventional

Funder types: Industry

Identifiers

NCT06055985

PD0060

Details and patient eligibility

About

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).

Enrollment: 207 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 3 patient groups, including a placebo group

UCB0022-Dose A

Experimental group

Description:

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

Treatment:

Drug: UCB0022

UCB0022-Dose B

Experimental group

Description:

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

Treatment:

Drug: UCB0022

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo