Recent Updates
Recently added Catalysts

ACI-7104.056

Phase 2

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

Target and mechanism

Molecular targetalpha-synuclein
Target classProtein
ModalityMonoclonal antibody

Also known as ACI-7104.056 at Dose A

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

FAST_TRACK

Clinical trial landscape

ACI-7104.056 · 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 Disease
NCT06015841150
Unlock 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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Parkinson's Disease 58 trials (matched to "Parkinson Disease")

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN2PHASE3apomorphine infusion
Prothena Corp. PlcPRTA3PHASE3Prasinezumab
Biohaven Ltd.BHVN1PHASE2BHV-8000
Denali Therapeutics Inc.DNLI1PHASE2BIIB122
AC Immune SAACIU2PHASE2ACI-7104.056 at Dose A, ACI-7104.056 at Dose B, ACI-7104.056 at Dose C
Gain Therapeutics, Inc.GANX2PHASE2Low Dose GT-02287
Eli Lilly and CompanyLLY3PHASE1LY3884961, Methylprednisolone, Sirolimus
Annovis Bio IncANVS1PHASE2buntanetap/posiphen
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
QIAGEN NVQGEN1PHASE2NEU-411
AbbVie, Inc.ABBV9 - Undisclosed
Illumina, Inc.ILMN1PHASE218F-MFBG
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Boston Scientific CorporationBSX3 - Undisclosed
AgeX Therapeutics, Inc.SER1PHASE1SER-252
Abbott LaboratoriesABT2N/AUndisclosed
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
Sage BionetworksSAGE1N/AUndisclosed
Unlock Competitive Intelligence