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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06015841A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's DiseasePHASE2 ACTIVE NOT_RECRUITING 150 — — Jul 24, 2023Jan 1, 2028Nov 21, 202512 Germany, Spain +1
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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 — 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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Competitive Landscape -Parkinson's Disease 59 trials
CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN2PHASE3apomorphine infusion
Prothena Corp. PlcPRTA3PHASE3Prasinezumab, RO7046015
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, GT-02287
BioVie Inc. Class ABIVI1PHASE2NE3107
Eli Lilly and CompanyLLY3PHASE1LY3884961, Methylprednisolone, Sirolimus, LY4006896, LY3962681
Annovis Bio IncANVS1PHASE2buntanetap/posiphen
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
QIAGEN NVQGEN1PHASE2NEU-411
AbbVie, Inc.ABBV9 — Undisclosed
Illumina, Inc.ILMN1PHASE218F-MFBG
Masimo CorporationMASI1PHASE1Diprivan , Astra-Zeneca
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
Boston Scientific CorporationBSX3 — Undisclosed
Serina TherapeuticsSER1PHASE1SER-252
Abbott LaboratoriesABT2NAUndisclosed
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06015841primaryCompletionDate: changed
LOWMay 24, 2026NCT06015841studyFirstPostDate: changed