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

Phase 2

Recruiting

• Conditions: Parkinson Disease; Multiple System Atrophy
• Interventions: Drug: exidavnemab; Drug: Placebo Comparator

• Registration Number: NCT06671938
• Lead Sponsor: BioArctic AB

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-19
• Study Start: 2024-10-24
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-03-16
• Study Completion: 2026-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
exidavnemab	exidavnemab	exidavnemab (cohort 1 - dose 1; cohort 2 - dose 2)
Placebo	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs.	From first dose to Day 176	Number of participants with adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (Plasma): Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (Clast)	Day 1 and Day 85	PK parameters (AUClast) following single dose, as calculated by the linear trapezoidal method
Establishment of an appropriate dose range for proof-of-concept trial	From first dose to Day 176	The recommended maximal dose will be defined by the safety and tolerability profile and PK data
Assessment of systemic immunogenicity effects of exidavnemab	From first dose to Day 176	Determination of ADAs in serum by using a tier-based approach followed by determination of NAbs if relevant.

Trial Locations

Locations (8)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Andalucia, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Centrum Medyczyne Neuromed Sp. z o.o.; 🇵🇱 Bydgoszcz, Poland

Specjalistyczne Gabinety Sp. z o.o.; 🇵🇱 Krakow, Poland

Krakowska Akademia Neurologii Sp. Z o.o; 🇵🇱 Krakow, Poland

Hospital Universitari General de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Policlínica Gipuzkoa; 🇪🇸 San Sebastián, Spain