NCT06671938

Safety, Tolerability, and Pharmacokinetics of Exidavnemab in Patients With Parkinson's Disease and Patients With Multiple System Atrophy

A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients With Mild to Moderate Parkinson's Disease on Stable Symptomatic Parkinson's Disease Medication and in Patients With Multiple System Atrophy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: BioArctic AB · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability of exidavnemab after multiple dosing versus placebo.

Detailed description

This Phase 2a, randomized, double-blind, placebo-controlled, multicenter, multinational, multiple ascending dose (MAD) trial is designed to investigate the safety, tolerability, and pharmacokinetics (PK) of exidavnemab in participants with mild to moderate Parkinson's Disease (PD) on stable symptomatic PD medication and Patients With Multiple System Atrophy. The trial will evaluate two dose cohorts versus placebo. Participants in each cohort will be randomly allocated in a 2:1 ratio to receive either exidavnemab or placebo. There will be approximately 12 evaluable participants with PD in Cohort 1 and approximately 24 evaluable participants in Cohort 2 (approximately 12 participants in each of Cohorts 2a and 2b), resulting in approximately 36 participants, 24 with PD and 12 with MSA, randomized in total.

Conditions

• Parkinson Disease
• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	exidavnemab	The trial medication will be administered as an intravenous (IV) infusion (dose 1; dose 2)
DRUG	Placebo Comparator	The trial medication will be administered as an intravenous (IV) infusion

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-08-17
• Completion: 2026-08-17
• First posted: 2024-11-04
• Last updated: 2026-03-10

Locations

7 sites across 2 countries: Poland, Spain

Regulatory

• FDA-regulated drug study