Current studies | UCB
UCB's Global Corporate Website

PD0053

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.

Medical Condition

Early-stage parkinson's disease

Min. Age

40
Years

Max. Age

75
Years

Who Can Join?

All

Status

Recruiting
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 Medication Description

Study Medication:

UCB0599

Other Descriptive Name:

UCB0599

Placebo

Yes

Comparator:

No

Study Dates

December 2020

Actual Start Date of Enrollment

July 2024

Planned Study Completion Date

General Information

Study ID:
PD0053
EudraCT Number:
2020-003265-19
CT.gov Number:
NCT04658186
Phase:
Phase 2

Interested in enrolling in our study?

Just contact us

Austria

UCBCares.AT@ucb.com
+43 (0) 1 291 80 08
0800-296176 (freephone)

Belgium

UCBCares.BE@ucb.com
+32 2 559 92 00
0800 38 008 (freephone)
www.ucbcares.be

Bulgaria

UCBCares.BG@ucb.com
+359 2 962 9933
www.ucbcares.bg

Czech Republic

UCBCares.CZ@ucb.com
+420 221 773 442
800 144 395 (freephone)
www.ucbcares.cz

Denmark

UCBCares.DK@ucb.com
+45 32462480
80 253827 (freephone)
www.ucbcares.dk

Finland

UCBCares.FI@ucb.com
+358 942733300
0800 9 13353 (freephone)
www.ucbcares.fi

France

UCBCares.FR@ucb.com
+33 1 47 29 45 55
0 805 222 949 (freephone)
www.ucbcares.fr

Germany

UCBCares.DE@ucb.com
+49 2173 48 48 48
www.ucbcares.de

Greece

UCBCares.GR@ucb.com
+30 21 0997 4200
0080 012 9910 (freephone)
www.ucbcares.gr

Hungary

UCBCares.HU@ucb.com
+36 1 472 5060
06 80 021 486 (freephone)
www.ucbcares.hu

Ireland

UCBCares.IE@ucb.com
+353 1 463 2371
1800 93 00 75 (freephone)
www.ucbcares.co.uk

Italy

UCBCares.IT@ucb.com
+39 02 3007 9300
8009-86932 (freephone)
www.ucbcares.it

Luxemburg

UCBCares.LU@ucb.com
+32 2 559 92 12
8002 3204 (freephone)

Norway

UCBCares.NO@ucb.com
+45 32462482
800-10101 (freephone)
www.ucbcares.no

Poland

UCBCares.PL@ucb.com
+48 22 596 97 97
00 800 121 68 25 (freephone)
www.ucbcares.pl

Portugal

UCBCares.PT@ucb.com
+351 213 025 300
800-8-56033 (freephone)

Romania

+4021 300 19 07

Slovakia

UCBCares.SK@ucb.com
+421 2 592 020 23
0800 002 566 (freephone)
www.ucbcares.sk

Spain

UCBCares.ES@ucb.com
+34 915 70 06 49
8000-99684 (freephone)
www.ucbcares.es

Sweden

UCBCares.SE@ucb.com
+45 32462481
0200 898 671 (freephone)
www.ucbcares.se

Switzerland

+41 58 822 3180

The Netherlands

UCBCares.NL@ucb.com
+31 76 573 1130
0800 3434335 (freephone)
www.ucbcares.nl

UK

UCBCares.UK@ucb.com
+44 1753 777 100
0800 279 3177 (freephone)
www.ucbcares.co.uk