Trials / Active Not Recruiting
Active Not RecruitingNCT06015841
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- AC Immune SA · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | 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. |
Timeline
- Start date
- 2023-07-24
- Primary completion
- 2028-01-01
- Completion
- 2028-01-01
- First posted
- 2023-08-29
- Last updated
- 2025-11-21
Locations
12 sites across 3 countries: Germany, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT06015841. Inclusion in this directory is not an endorsement.