A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
NCT06055985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2026-04-06
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
Interventions
- OTHER
-
Placebo
Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.
- DRUG
-
UCB0022
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Sponsors & Collaborators
-
UCB Biopharma SRL
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-17
- Primary Completion
- 2025-03-31
- Completion
- 2025-04-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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