---
title: 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
euct_id: 2022-500292-31-00
phase: Phase 4
status: Recruiting
sponsor: AC Immune S.A.
canonical_url: "https://parkinsonspathways.com/trials/eu/2022-500292-31-00"
eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2022-500292-31-00"
ctis_last_updated: "2025-09-18T03:34:25.795054374"
source: EU Clinical Trials Information System (CTIS)
---
# 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

**EU CT Number:** [2022-500292-31-00](https://euclinicaltrials.eu/ctis-public/view/2022-500292-31-00)

## Key Facts

- **Phase:** Phase 4
- **Status:** Recruiting
- **Sponsor:** AC Immune S.A.
- **Start Date:** 2022-09-26
- **Completion Date:** 2028-01-31
- **Conditions:** Early stages of idiopathic Parkinson's Disease, Parkinson's disease
- **Interventions:** ACI-7104.056, DaTSCAN 74 MBq/ml solution for injection, Placebo (PBS-ALH02), adjuvanted solution matching the study vaccine formulation

## Member States

Trial is authorized in 2 member states: Germany, Spain.

## Sites (10)

- Hospital Universitari General De Catalunya, Barcelona, Spain
- Hospital Universitario Quironsalud Madrid, Pozuelo De Alarcon, Spain
- Hospital Universitari Vall D Hebron, Barcelona, Spain
- Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
- Hospital Universitario Puerta De Hierro De Majadahonda, Majadahonda, Spain
- Policlinica Gipuzkoa, Donostia, Spain
- Hospital Universitario De La Princesa, Madrid, Spain
- University Medical Centre Schleswig-Holstein, Kiel, Germany
- Paracelsus-Kliniken Deutschland GmbH & Co. KGaA, Osnabrück, Germany
- Katholisches Klinikum Bochum gGmbH, Bochum, Germany

## Eligibility (CTIS)

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Condition: Early stages of idiopathic Parkinson's Disease; Parkinson's disease
Age groups: elderly 65+, adults 18-64
Sex: male, female
Includes a vulnerable population.

Period: 1 initial and 2 optional cohorts with 3:1 active treatment/placebo ratio with 75 µg dose.
1 expansion cohort with adjusted randomization ratio to achieve an active treatment/placebo ratio of 2:1 in this cohort.
Arms:
  - Study vaccine (ACI-7104.056): The maximum dose of study vaccine administered in a single dose will be 75 µg net peptide; smaller doses of study vaccine may be used following IA, with the support of DSMB recommendation. Randomized PD subjects will receive 6 injections of study vaccine or placebo, at Week 0 (baseline), Week 4, Week 12, Week 24, Week 48, and Week 74.
Blinding: The study subjects, contract research organizations (CROs), study vendors, Sponsor, and site personnel will be blinded to treatment assignment until the data lock taking place after the end of the last subject last visit.
```

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