NCT06055985

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-03-31
• Completion: 2025-04-11
• First posted: 2023-09-28
• Last updated: 2026-04-06

Locations

61 sites across 1 country: United States

Regulatory

• FDA-regulated drug study