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ADX-097

Phase 2

IgA Nephropathy | Small molecule | Nephrology |Q32 Bio Inc.|Last Updated: Jul 9, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical trial landscape

ADX-097 · 1 trial · 3 indications

Phase 2 1
NCT06419205A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3GIgA Nephropathy
NOT YET_RECRUITING30 Analytics
PHASE2NOT YET_RECRUITING
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
IgA Nephropathy
NCT0641920530
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Study Endpoints
Primary Endpoints
Number of participants reporting treatment emergent adverse events (TEAEs)
Up to 30 weeks
Secondary Endpoints
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Baseline and up to 26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Baseline and up to 26 weeks
Trough plasma Concentration of ADX-097
At Days 1, 8, 22, 50, 78, 106, 134 and 176
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open Label: ADX-097OTHERParticipants will be administered ADX-097 weekly once
Interventions
NameTypeDescription
ADX-097DRUGSubcutaneous Infusions
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Eligibility Criteria
Age Range16 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: All participants 1. Male or female participants aged ≥16 years. 2. uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]). 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR). ...

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Competitive Landscape -IgA Nephropathy 26 trials
CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS10PHASE3BION-1301
Vera Therapeutics, Inc. Class AVERA4PHASE3Atacicept
Travere Therapeutics, Inc.TVTX2PHASE3sparsentan, irbesartan, Dapagliflozin
Biogen Inc.BIIB1PHASE3Felzartamab
AstraZeneca PLCAZN2PHASE3Ravulizumab
Vertex Pharmaceuticals IncorporatedVRTX2PHASE3Povetacicept
Biohaven Ltd.BHVN1PHASE1BHV-1400
Jade Biosciences, Inc.JBIO1PHASE2JADE101
Q32 Bio IncQTTB1PHASE2ADX-097
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