UCB's Global Corporate Website

PD0060

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).

Medical Condition

Parkinson Disease

Min. Age

35
Years

Max. Age

80
Years

Who Can Join?

All

Status

Recruiting
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: a) 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 b) 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%)

Study Medication Description

Study Medication:

UCB0022

Other Descriptive Name:

UCB0022 (D1 PAM)

Placebo

Yes

Comparator:

No

Study Dates

November 2023

Actual Start Date of Enrollment

December 2024

Planned Study Completion Date

General Information

Study ID:
PD0060
CT.gov Number:
NCT06055985
Phase:
Phase 2

Interested in our clinical studies?

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

Canada

+1 866 709 8444

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

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