Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Study participant must be 40 to 75 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 Visit (including diagnosis during Screening) - 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), or a historical DaT-SPECT within 3 months of the Screening Visit that has been qualified by the central reader, shows evidence of dopamine transporter deficit per study requirements and as determined by a central reader - Study participant is in the ≤2.5 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 does not take N-acetyl cysteine or other cysteine donors or glutathione precursors on a regular basis as a food supplement - Study participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection - Study participant has a body mass index (BMI) of 16 to 34kg/m² (inclusive) - Contraception i) A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose ofstudy medication and refrain from donating sperm during this period ii) A female participant is eligible to participate if she is not pregnant, not breastfeeding, andat least one of the following conditions applies: 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, which is to be 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 as a study medication related-gastrointestinal upset or a drug interaction by CYP3A4 induction could interfere with efficacy

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 vasculopathy - 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. The participant must be excluded from lumbar puncture but not from study participation - 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. Short (up to 4 weeks) past use of medications for the treatment of motor symptoms is permitted following a sufficient washout period. Medications included are: levodopa (maximum 400mg per day), dopamine agonists, monoamine oxidase B (MAO-B) inhibitors, anticholinergics, or amantadine. A sufficient washout period is at least 3 months prior to the Baseline Visit

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UCB0599 High Dose Arm
Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period.
  • Drug: UCB0599
    Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
Placebo Comparator
Placebo Arm
Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period.
  • Drug: Placebo
    Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.
Experimental
UCB0599 Low Dose Arm
Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period.
  • Drug: UCB0599
    Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.

Recruiting Locations

Pd0053 50140
Birmingham, Alabama 35233

Pd0053 50506
Phoenix, Arizona 85004-1150

Pd0053 50081
Phoenix, Arizona 85013

Pd0053 50391
Tucson, Arizona 85710

Pd0053 50539
Little Rock, Arkansas 72205

Pd0053 50519
Fountain Valley, California 92708

Pd0053 50385
Fresno, California 93710

Pd0053 50416
La Jolla, California 92037

Pd0053 50118
Los Angeles, California 90033

Pd0053 50531
Englewood, Colorado 80113

Pd0053 50392
Danbury, Connecticut 06810

Pd0053 50538
Farmington, Connecticut 06030-5357

Pd0053 50396
Boca Raton, Florida 33486

Pd0053 50524
Bradenton, Florida 34205

Pd0053 50199
Miami, Florida 33136

Pd0053 50394
Tampa, Florida 33613

Pd0053 50544
Augusta, Georgia 30912-0004

Pd0053 50401
Chicago, Illinois 60611

Pd0053 50310
Chicago, Illinois 60612-3863

Pd0053 50399
Winfield, Illinois 60190

Pd0053 50549
Iowa City, Iowa 52242

Pd0053 50074
Kansas City, Kansas 66160

Pd0053 50121
Lexington, Kentucky 40536-0284

Pd0053 50395
New Orleans, Louisiana 70121

Pd0053 50529
Baltimore, Maryland 21201-1606

Pd0053 50547
Baltimore, Maryland 21287

Pd0053 50243
Boston, Massachusetts 02114

Pd0053 50546
Worcester, Massachusetts 01655

Pd0053 50545
East Lansing, Michigan 48824

Pd0053 50386
Farmington Hills, Michigan 48334

Pd0053 50536
Saint Paul, Minnesota 55130

Pd0053 50397
Las Vegas, Nevada 89104

Pd0053 50299
New Brunswick, New Jersey 08901

Pd0053 50303
Albany, New York 12208-3412

Pd0053 50077
New York, New York 10021-4823

Pd0053 50521
New York, New York 10029

Pd0053 50119
New York, New York 10032

Pd0053 50530
Stony Brook, New York 11794

Pd0053 50535
Williamsville, New York 14221

Pd0053 50372
Cleveland, Ohio 44106

Pd0053 50311
Cleveland, Ohio 44195

Pd0053 50255
Columbus, Ohio 43210

Pd0053 50527
Toledo, Ohio 43606

Pd0053 50398
Tulsa, Oklahoma 74136

Pd0053 50510
Portland, Oregon 97239

Pd0053 50526
Philadelphia, Pennsylvania 19107

Pd0053 50084
Charleston, South Carolina 29425

Pd0053 50532
Knoxville, Tennessee 37920

Pd0053 50543
Memphis, Tennessee 38157

Pd0053 50525
Houston, Texas 77030-5301

Pd0053 50113
Houston, Texas 77030

Pd0053 50400
San Antonio, Texas 78229-3900

Pd0053 50537
Salt Lake City, Utah 84108-1218

Pd0053 50107
Burlington, Vermont 05401

Pd0053 50542
Charlottesville, Virginia 22908

Pd0053 50410
Fairfax, Virginia 22031

Pd0053 50534
Virginia Beach, Virginia 23456

Pd0053 50292
Kirkland, Washington 98034-3030

Pd0053 50419
Spokane, Washington 99202

Pd0053 50402
Crab Orchard, West Virginia 25827

More Details

NCT ID
NCT04658186
Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
1-844-599-2273 (USA)
UCBCares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.