Assessing the safety and tolerability of exidavnemab in Parkinson's Disease patients

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

This study is testing a new drug called exidavnemab to see if it's safe and well-tolerated in people with mild to moderate Parkinson's Disease who are already on stable medication.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: BioArctic AB (Industry-sponsored)
• Drugs / interventions: exidavnemab
• Locations: 6 sites (Bydgoszcz and 5 other locations)
• Trial ID: NCT06671938 on ClinicalTrials.gov

What this trial studies

This Phase 2a trial evaluates the safety, tolerability, and pharmacokinetics of exidavnemab in patients with mild to moderate Parkinson's Disease who are on stable medication. The study is randomized, double-blind, and placebo-controlled, involving multiple ascending doses of the drug. Participants will be allocated in a 2:1 ratio to receive either exidavnemab or a placebo, with a total of approximately 24 participants across two dose cohorts. The trial aims to provide insights into the drug's effects compared to a placebo over multiple doses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 85 with mild to moderate idiopathic Parkinson's Disease who are stable on their current medication.

Not a fit: Patients with advanced Parkinson's Disease or those with cognitive impairment consistent with dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option that improves the management of Parkinson's Disease symptoms.

How similar studies have performed: Other studies have shown promise with similar approaches in treating Parkinson's Disease, but the specific use of exidavnemab is novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female participants 40 to 85 years of age.
2. Body weight more than or equal to 50 kg and less than or equal to 120 kg.
3. 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).
4. Classified as Stage 1 to 2.5 on the modified Hoehn and Yahr scale for the staging of PD severity.
5. Participants must have cognition inconsistent with dementia as confirmed by a score of more than or equal to 22 on the MoCA.
6. 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.
7. 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.
8. 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.

Exclusion Criteria:

1. Known hypersensitivity to trial medication, the infusion solution, or excipients.
2. More than 5 years of symptomatic treatment for PD.
3. History of neurosurgical intervention for PD including implantation of brain stimulation.
4. Diagnosis of PD dementia or another dementia.
5. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
6. Freezing episodes occurring on a weekly basis or more frequently.
7. Motor fluctuations occurring on a weekly basis or more frequently.
8. 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.

Where this trial is running

Bydgoszcz and 5 other locations

• Centrum Medyczyne Neuromed Sp. z o.o. — Bydgoszcz, Poland (Recruiting)
• Specjalistyczne Gabinety Sp. z o.o. — Krakow, Poland (Withdrawn)
• Krakowska Akademia Neurologii Sp. Z o.o — Krakow, Poland (Recruiting)
• Hospital Universitari General de Catalunya — Sant Cugat del Valles, Barcelona, Spain (Recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
• Policlínica Gipuzkoa — San Sebastián, Spain (Recruiting)

Study contacts

• Study coordinator: BioArtic AB

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