NCT04658186

A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-stage Parkinson's Disease

Interventions

Type	Name	Description
DRUG	UCB0599	Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
DRUG	Placebo	Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.

Timeline

• Start date: 2020-12-30
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2020-12-08
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

115 sites across 9 countries: United States, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study