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

NCT06055985 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PD0060
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 61

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).

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Phase 2; UCB0022; wearing-off; motor fluctuations

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days

  The Hauser Parkinson's disease (PD) symptoms diary is a study participant-completed diary that records the daily ON time and OFF time of study participants with PD with motor fluctuations and dyskinesia.

  From Baseline (Day 1) to Visit 9 (Day 70)

Secondary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs)

  From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

• Incidence of treatment-emergent serious adverse events (SAEs)

  From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

• Incidence of TEAEs leading to withdrawal from the study

  From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

• Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)

  at Visit 9 (Day 70)

Study Arms (3)

UCB0022-Dose A

EXPERIMENTAL

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

Drug: UCB0022

UCB0022-Dose B

EXPERIMENTAL

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

Drug: UCB0022

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.

Placebo

UCB0022 DRUG

Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.

UCB0022-Dose A; UCB0022-Dose B

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• A female study participant must not be a woman of childbearing potential (WOCBP)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (61)

Pd0060 50506

Phoenix, Arizona, 85004, United States

Location

Pd0060 50590

Scottsdale, Arizona, 85258, United States

Location

Pd0060 50608

Little Rock, Arkansas, 72205, United States

Location

Pd0060 50519

Fountain Valley, California, 92708, United States

Location

Pd0060 50428

Fresno, California, 93710, United States

Location

Pd0060 50601

Loma Linda, California, 92354, United States

Location

Pd0060 50589

Los Alamitos, California, 90720, United States

Location

Pd0060 50587

Los Angeles, California, 90033, United States

Location

Pd0060 50452

Pasadena, California, 91106, United States

Location

Pd0060 50598

Englewood, Colorado, 80113, United States

Location

Pd0060 50628

New Haven, Connecticut, 06519, United States

Location

Pd0060 50610

Newark, Delaware, 19713, United States

Location

Pd0060 50600

Altamonte Springs, Florida, 32714, United States

Location

Pd0060 50616

Aventura, Florida, 33180, United States

Location

Pd0060 50596

Boca Raton, Florida, 33486, United States

Location

Pd0060 50524

Bradenton, Florida, 34205, United States

Location

Pd0060 50647

DeLand, Florida, 32720, United States

Location

Pd0060 50577

Doral, Florida, 33172, United States

Location

Pd0060 50584

Hollywood, Florida, 33021, United States

Location

Pd0060 50582

Miami, Florida, 33122, United States

Location

Pd0060 50579

Miami, Florida, 33125, United States

Location

Pd0060 50449

Miami, Florida, 33133, United States

Location

Pd0060 50580

Miami, Florida, 33176, United States

Location

Pd0060 50597

Naples, Florida, 34105, United States

Location

Pd0060 50591

Ocala, Florida, 34470, United States

Location

Pd0060 50605

Port Orange, Florida, 32127, United States

Location

Pd0060 50620

St. Petersburg, Florida, 33710, United States

Location

Pd0060 50603

Tampa, Florida, 33609, United States

Location

Pd0060 50585

Winter Park, Florida, 32789, United States

Location

Pd0060 50075

Augusta, Georgia, 30912, United States

Location

Pd0060 50595

Indianapolis, Indiana, 46256, United States

Location

Pd0060 50319

Iowa City, Iowa, 52242, United States

Location

Pd0060 50074

Kansas City, Kansas, 66160, United States

Location

Pd0060 50561

Lexington, Kentucky, 40536-0284, United States

Location

Pd0060 50615

Boston, Massachusetts, 02118, United States

Location

Pd0060 50085

Boston, Massachusetts, 02215, United States

Location

Pd0060 50627

North Dartmouth, Massachusetts, 02747, United States

Location

Pd0060 50110

Ann Arbor, Michigan, 48109-0944, United States

Location

Pd0060 50545

East Lansing, Michigan, 48824, United States

Location

Pd0060 50386

Farmington Hills, Michigan, 48334, United States

Location

Pd0060 50613

Grand Rapids, Michigan, 49503, United States

Location

Pd0060 50614

New York, New York, 10021, United States

Location

Pd0060 50521

New York, New York, 10029, United States

Location

Pd0060 50612

Raleigh, North Carolina, 27607, United States

Location

Pd0060 50087

Centerville, Ohio, 45459, United States

Location

Pd0060 50622

Cleveland, Ohio, 44195, United States

Location

Pd0060 50076

Columbus, Ohio, 43221, United States

Location

Pd0060 50604

Dayton, Ohio, 45449, United States

Location

Pd0060 50527

Toledo, Ohio, 43614, United States

Location

Pd0060 50398

Tulsa, Oklahoma, 74136, United States

Location

Pd0060 50607

Portland, Oregon, 97210, United States

Location

Pd0060 50619

Rock Hill, South Carolina, 29732, United States

Location

Pd0060 50496

Round Rock, Texas, 78681, United States

Location

Pd0060 50568

San Antonio, Texas, 78229, United States

Location

Pd0060 50537

Salt Lake City, Utah, 84108, United States

Location

Pd0060 50143

Henrico, Virginia, 23233, United States

Location

Pd0060 50534

Virginia Beach, Virginia, 23456, United States

Location

Pd0060 50440

Bellevue, Washington, 98004, United States

Location

Pd0060 50292

Kirkland, Washington, 98034, United States

Location

Pd0060 50419

Spokane, Washington, 99202, United States

Location

Pd0060 50402

Crab Orchard, West Virginia, 25827, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor and CRO staff is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: November 17, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 11, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal

Locations

US (61)