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

NCT06671938 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: BAN0805-2012024-511222-30-00
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Parkinson Disease; Multiple System Atrophy

Keywords

Parkinson Disease; Exidavnemab; EXIST; BAN-0805; ABBV-0805; alfa-synuclein

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs).

  Number of participants with adverse events (AEs) and serious adverse events (SAEs).

  From first dose to Day 176

Secondary Outcomes (3)

• 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

• Establishment of an appropriate dose range for proof-of-concept trial

  From first dose to Day 176

• Assessment of systemic immunogenicity effects of exidavnemab

  From first dose to Day 176

Study Arms (2)

exidavnemab

EXPERIMENTAL

exidavnemab (cohort 1 - dose 1; cohort 2 - dose 2)

Drug: exidavnemab

Placebo

PLACEBO COMPARATOR

Drug: Placebo Comparator

Interventions

exidavnemab DRUG

The trial medication will be administered as an intravenous (IV) infusion (dose 1; dose 2)

exidavnemab

Placebo Comparator DRUG

The trial medication will be administered as an intravenous (IV) infusion

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants 40 to 85 years of age.
• Body weight more than or equal to 50 kg and less than or equal to 120 kg.
• Have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by bradykinesia combined with at least 1 of resting tremor and rigidity, as per the Movement Disorder Society Criteria for PD (Postuma, et al. 2015).
• Classified as Stage 1 to 2.5 on the modified Hoehn and Yahr scale for the staging of PD severity.
• Participants must have cognition inconsistent with dementia as confirmed by a score of more than or equal to 22 on the MoCA.
• Stable and optimized symptomatic PD medication, defined as the same list of medications for at least 3 months prior to the Screening Visit with no change in the dose for at least 1 month prior to the Baseline Visit, and no planned changes in dose-regimen during trial participation.
• Prior (any time; i.e., no time limit) or current DaT-SPECT or DaT-PET consistent with dopamine transporter deficit, as per the Movement Disorder Society Criteria for PD(Postuma, et al. 2015). For participants who have not undergone DaT-SPECT or DaT-PET prior to Screening, or who have previously undergone DaT-SPECT or DaT-PET scan(s) but without results consistent with dopamine transporter deficit, DaT-SPECT or DaT-PET should be performed and read locally as part of the Screening procedures.
• Positive smell test showing hyposmia, as defined by UPSIT scores of around or below the 15% percentile for their relevant sex and age group. Cut-off scores are provided below for reference (Table 5.1; based on Brumm, et al. 2023) Ability to use a tablet device to measure cognitive function, as per Investigator judgment.
• Male and female participants 40 to 85 years of age.
• Body weight more than or equal to 50 kg and less than or equal to 120 kg.
• Have clinically established or clinically probable MSA (either MSA-P or MSA-C), as per the Movement Disorder Society criteria for the diagnosis of MSA (Wenning, et al. 2022).
• Classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for the staging of MSA severity.
• Participants must have cognition inconsistent with dementia as confirmed by a score of more than or equal to 22 on the MoCA.
• Negative urine or serum pregnancy test at the Screening Visit and Baseline for premenopausal women, and for women who have experienced menopause onset less than 12 months prior to the first planned dose of trial medication.
• Males and POCBP must agree to practice an effective means of birth control during their participation in the trial and until 3 months after their last dose of the trial medication. See specific guidelines regarding contraceptive methods in Section 14.1.

You may not qualify if:

• Known hypersensitivity to trial medication, the infusion solution, or excipients.
• More than 5 years of symptomatic treatment for PD.
• History of neurosurgical intervention for PD including implantation of brain stimulation.
• Diagnosis of PD dementia or another dementia.
• Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
• Freezing episodes occurring on a weekly basis or more frequently.
• Motor fluctuations occurring on a weekly basis or more frequently.
• Levodopa-induced troublesome dyskinesia of a severity that would significantly interfere with the participant's ability to participate or perform trial procedures as determined by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Subscale IV.
• Known hypersensitivity to the trial medication, the infusion solution, or excipients.
• Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
• History of significant cardiovascular disease or arrhythmia within 6 months of Screening.
• Abnormal ECG that is or may be clinically significant in the Investigator's opinion and after consultation with the Medical Monitor, including left bundle branch block, atrial fibrillation, QTcF more than 450 msec for males and more than 470 msec for females at the Screening Visit or Baseline.
• History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.
• Abnormal liver function tests: GGT, TBil, ALP, ALT, and AST higher than the ULN and regarded as potentially clinically significant by the Investigator.
• Poorly controlled diabetes as defined by hemoglobin A1C of more than 8%.

Sponsors & Collaborators

• BioArctic AB: lead
• Worldwide Clinical Trials: collaborator

Study Sites (7)

Centrum Medyczyne Neuromed Sp. z o.o.

Bydgoszcz, 85-163, Poland

Location

Krakowska Akademia Neurologii Sp. Z o.o

Krakow, 31-505, Poland

Location

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Policlínica Gipuzkoa

San Sebastián, 20014, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in each cohort will be randomly allocated in a 2:1 ratio to receive either exidavnemab or placebo.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial will evaluate 2 dose cohorts, dose 1 exidavnemab versus placebo (Cohort 1) and dose 2 exidavnemab versus placebo (Cohort 2). Cohort 2 will consist of a PD cohort (Cohort 2a) and an MSA cohort (Cohort 2b).

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: November 4, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); ES (5)