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ADX-097 in IgAN, LN, or C3G
NCT06419205Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Feb 2028
- Countries
- 2
- Sponsor
- Akebia Therapeutics
- Modality
- Monoclonal Antibodies, Fc-Fusion Proteins
- Drugs
- ADX-097
- Conditions
- IgA nephropathy (IgAN)lupus nephritis (LN)Complement 3 glomerulopathy (C3G)
01
Overview
Phase 2, open-label, single-arm trial of ADX-097 in IgA nephropathy (IgAN), lupus nephritis (LN) and Complement 3 glomerulopathy (C3G), sponsored by Akebia Therapeutics. Primary endpoint: Number of participants reporting treatment emergent adverse events at 30 weeks. Started Jul 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Open Label: ADX-097
Participants will be administered ADX-097 weekly once via subcutaneous infusion.
03
Who it enrols
Participants aged >=16 with biopsy-proven IgAN, LN, or C3G, uPCR >=0.5 g/g, and eGFR >=30 mL/min/1.73m2. Must be on stable background therapy and not have rapidly progressive glomerulonephritis, uncontrolled hypertension, or recent use of excluded immunosuppressive therapies.
04
Endpoints
Primary
Number of participants reporting treatment emergent adverse events
Secondary
Change from baseline in urine protein-to-creatinine ratio
Change from baseline in estimated glomerular filtration rate
Trough plasma Concentration of ADX-097
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