skip to Main Content

A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease


Brief Summary:

The purpose of the study is to assess the safety and tolerability of UCB0599 and to
demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of
disease progression over 12 and 18 months in participants diagnosed with early-stage
Parkinson’s Disease.


Inclusion Criteria:

– Study participant must be 40 to 70 years of age inclusive, at the time of signing the
informed consent

– Study participant has Parkinson’s Disease (PD), with a diagnosis made by a neurologist
according to the 2015 Movement Disorder Society criteria within 2 years of Baseline

– The following diagnostic criteria must be met: bradykinesia AND at least ONE of the
following: muscular rigidity, or resting tremor

– A Screening Dopamine Transporter Imaging with Single Photon Emission Computed
Tomography (DaT-SPECT) is consistent with PD as determined by a central reader

– Study participant has no clear family history of autosomal-dominant forms of PD or
confirmation of such mutations by genetic testing. Historical genetic testing
information will be considered but is not required and will not be conducted for
Screening purposes

– Study participant is in the ≤2 modified Hoehn and Yahr stage at Screening

– Study participant has never taken medications for the treatment of motor symptoms of
PD and is not expected to require starting symptomatic treatment (ST) with a high
likelihood in the next 6 months as far as clinical judgement allows

– Study participant has never taken part in disease-modifying treatment studies directed
at neurodegenerative disease (NDD)

– Study participant is willing, competent, and able to comply with all aspects of the
protocol, including follow-up schedule and biospecimen collection

– A male participant must agree to use contraception during the Treatment Period and for
at least 90 days after the last dose of study medication and refrain from donating
sperm during this period

– A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least one of the following conditions applies:

(i) Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the
contraceptive guidance during the Treatment Period and for at least 1 month after the
last dose of study medication. The study participant must have a negative serum
pregnancy test at Screening (Visit 1), which is to confirmed negative by urine testing
prior to the first dose of study medication at Baseline (Visit 3). If oral
contraception is used, an additional barrier method will be required during the study

Exclusion Criteria:

– Study participant has a known hypersensitivity to any components (and/or its
excipients) of the study medication or comparative drugs as stated in the protocol

– Study participant has a brain magnetic resonance imaging (MRI) scan performed during
Screening indicative of a clinically significant abnormality or a historical MRI scan
during the 6 months before Screening Visit 1 of sufficient quality to show such
abnormalities. In case of doubt, the significance is determined on a case-by-case
basis in close collaboration with the Medical Monitor and should not include
abnormalities like age-appropriate brain atrophy, minor white matter signals, or mild

– Study participant has any contraindication for the brain MRI or Dopamine Transporter
Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging

– Study participant has a Montreal Cognitive Assessment (MoCA) score less than 23,
indicating mild cognitive impairment or other significant cognitive impairment or
clinical dementia at Screening that, in the opinion of the Investigator, would
interfere with study evaluation

– Study participant has abnormalities in lumbar spine previously known or determined by
a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the
opinion of the Investigator

– Study participant has clinically significant electrocardiogram (ECG) abnormality at
Screening, in the opinion of the Investigator

– Study participant has past history of use of medications for the treatment of motor
symptoms of PD (with the exception of short pharmacological testing for confirmation
of diagnosis) or drugs with a potential PD disease modifying effect


  • Pd0053 50385, Fresno, California, United States, 93710
Back To Top