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ACI-7104.056 at Dose A

Phase 2

Parkinson Disease | Monoclonal antibody | Neurology |AC Immune SA|Last Updated: Nov 21, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ACI-7104.056 at Dose A · 1 trial · 2 indications

Phase 2 1
NCT06015841A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's DiseaseParkinson Disease
ACTIVE NOT_RECRUITING150 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
From Screening (ICF signature) to Week 100
Number of participants with abnormal MRI results
From Baseline to Week 100
Number of participants with clinically significant changes in physical and neurological examination results
From Baseline to Week 74
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
From Baseline to Week 100
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
From Baseline to Week 100

Secondary Endpoints

Measures of alpha-synuclein (a-syn) related biofluid biomarkers
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
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
From Baseline to Week 100
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOREarly PD subjects receive placebo at pre-defined time points over 74 weeks.
ACI-7104.056 at Dose AEXPERIMENTALEarly PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks.
ACI-7104.056 at Dose B (optional)EXPERIMENTALEarly PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
ACI-7104.056 at Dose C (optional)EXPERIMENTALEarly PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.

Interventions

NameTypeDescription
PlaceboBIOLOGICALThe placebo is a solution matching the study treatment formulation.
ACI-7104.056 at Dose ABIOLOGICALThe study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
ACI-7104.056 at Dose B (optional)BIOLOGICALThe study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
ACI-7104.056 at Dose C (optional)BIOLOGICALThe study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: 1. Confirmed diagnosis of clinically established early PD using the modified Movement Disorder Society criteria, after excluding any other known or suspected cause of PD. The presence of motor symptoms should not be of more than 2 years at screening. 2. Monotherapy treatment wit...

Countries:GermanySpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT06015841primaryCompletionDate: changed
LOWMay 24, 2026NCT06015841studyFirstPostDate: changed

Frequently asked questions about ACI-7104.056 at Dose A

What is ACI-7104.056 used for in Parkinson Disease?

ACI-7104.056 is an investigational monoclonal antibody being developed for the treatment of early stages of Parkinson's Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with early-onset Parkinson's Disease.

What does ACI-7104.056 target?

ACI-7104.056 is a monoclonal antibody designed to target a specific protein involved in Parkinson's Disease pathology. As a monoclonal antibody, it is intended to bind to its target and modulate the disease process. The exact molecular target has not been disclosed in available information.

Who is developing ACI-7104.056?

ACI-7104.056 is being developed by AC Immune SA, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ACIU. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Parkinson's Disease.

What phase is ACI-7104.056 in?

ACI-7104.056 is currently in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 2 trial is active but not recruiting participants, indicating that enrollment has been completed and the study is ongoing.

What clinical trials is ACI-7104.056 in?

ACI-7104.056 is being evaluated in a Phase 2 clinical trial with the identifier NCT06015841. This randomized, double-blind, placebo-controlled study is assessing the effects of the drug in patients with early stages of Parkinson's Disease. The trial has an enrollment of 150 participants and is being conducted in Germany, Spain, and the United Kingdom.

Is ACI-7104.056 the same as ACI-7104?

ACI-7104.056 is the specific drug candidate being studied in clinical trials. It is a monoclonal antibody developed by AC Immune SA for Parkinson's Disease. The name ACI-7104.056 may refer to a particular formulation or version of the drug, but no alternative names have been disclosed in available information.