An Adaptive, Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Parkinson Disease
- Sponsor
- AC Immune SA
- Enrollment
- 150
- Locations
- 12
- Primary Endpoint
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease.
Detailed Description
This is a prospective, multicenter, placebo-controlled, double-blind, randomized study with adaptive features, comprising a screening period of up to 8 weeks, a 74-week double-blind treatment period, and a 26-week post-treatment follow-up period. Up to 3 cohorts will include 16 subjects each (12 under the study treatment and 4 under placebo; 3:1 active treatment/placebo ratio). One of the initial potential 3 cohorts (Cohorts 2 and 3 are optional) may be expanded in order to reach an overall total of up to 150 subjects in the study. In case a cohort is expanded, the randomization ratio will be adjusted to achieve an active treatment/placebo ratio of 2:1 in this cohort. The route of administration of the study treatment and placebo will be by intramuscular injections.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Early PD subjects receive placebo at pre-defined time points over 74 weeks.
Intervention: Placebo
ACI-7104.056 at Dose A
Early PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks.
Intervention: ACI-7104.056 at Dose A
ACI-7104.056 at Dose B (optional)
Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
Intervention: ACI-7104.056 at Dose B (optional)
ACI-7104.056 at Dose C (optional)
Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
Intervention: ACI-7104.056 at Dose C (optional)
Outcomes
Primary Outcomes
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
Time Frame: From Screening (ICF signature) to Week 100
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
Time Frame: From Baseline to Week 100
Number of participants with abnormal MRI results
Time Frame: From Baseline to Week 100
Number of participants with clinically significant changes in physical and neurological examination results
Time Frame: From Baseline to Week 74
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: From Baseline to Week 100
Secondary Outcomes
- Measures of alpha-synuclein (a-syn) related biofluid biomarkers(From Baseline to Week 100)
- Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III(From Baseline to Week 100)
- Measurement of levels of dopamine transporter proteins in specific brain regions, notably substantia nigra, by Dopamine Transporter-Single Photon Emission Computerized Tomography (DaT-SPECT) imaging(From Baseline to Week 100)