A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
NCT06015841 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-11-21
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.
Conditions
- Parkinson Disease
- Parkinson Disease 6, Early-Onset
Interventions
- BIOLOGICAL
-
The placebo is a solution matching the study treatment formulation.
- BIOLOGICAL
-
ACI-7104.056 at Dose A
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
- BIOLOGICAL
-
ACI-7104.056 at Dose B (optional)
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
- BIOLOGICAL
-
ACI-7104.056 at Dose C (optional)
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
Sponsors & Collaborators
-
ICON Clinical Research
collaborator INDUSTRY -
AC Immune SA
lead INDUSTRY
Principal Investigators
-
Daniela Berg, Prof. · Klinik für Neurologie, UKSH Campus Kiel, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-24
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
Countries
- Germany
- Spain
- United Kingdom
Study Locations
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