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Atacicept

Phase 3

IgA Nephropathy | Monoclonal antibody | Nephrology |Vera Therapeutics, Inc.|Last Updated: Sep 30, 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 Enrollment376
FDA Designations
BREAKTHROUGH_THERAPYACCELERATED_APPROVAL
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04716231Atacicept in Subjects With IgA NephropathyPHASE3 ACTIVE NOT_RECRUITING 376Jun 29, 2023Jul 1, 2028Sep 30, 20251 United States
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Study Endpoints
Primary Endpoints
Change from baseline in urine protein to creatinine ratio (UPCR)
36 Weeks

UPCR based on 24 hour urine collection

Secondary Endpoints
Annualized rate of change in estimated glomerular filtration rate (eGFR)
52 and 104 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Atacicept Dose 150mgEXPERIMENTALAtacicept 150mg once weekly subcutaneous (SC) injections
Placebo to match Atacicept (Part C/D)PLACEBO_COMPARATORPlacebo to match Atacicept once weekly subcutaneous (SC) injection
Interventions
NameTypeDescription
AtaciceptBIOLOGICALOnce weekly subcutaneous (SC) injections by prefilled syringe
Placebo to match AtaciceptOTHEROnce weekly subcutaneous (SC) injections by prefilled syringe
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form * Male or female of ≥18 years of age * Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04716231primaryCompletionDate: changed
LOWMay 24, 2026NCT04716231studyFirstPostDate: changed