NCT06419205
Withdrawn
Phase 2
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With IgAN, LN, or C3G
Overview
- Phase
- Phase 2
- Intervention
- ADX-097
- Conditions
- IgA Nephropathy
- Sponsor
- Q32 Bio Inc.
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Incidence of adverse events (AEs) to evaluate the safety of ADX-097
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female participants aged ≥18 years.
- •Urine protein ≥ 0.75 g/24 hours or uPCR ≥ 0.5g/g
- •Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
- •Participants receiving a RAAS inhibitor must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
- •Participants receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor or sparsentan must have been on a stable dose for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
- •Kidney biopsy-proven diagnosis of IgAN within 52 week; LN within 12 weeks or C3G within 52 weeks of Day 1 and with evidence of C3 fragment deposition.
- •Key Exclusion Criteria
- •A ≥50% decline in eGFR within 3 months before screening.
- •Concomitant significant renal disease other than IgAN, C3G, or LN.
- •Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment.
Exclusion Criteria
- Not provided
Arms & Interventions
Open Label
Subcutaneous Infusions
Intervention: ADX-097
Outcomes
Primary Outcomes
Incidence of adverse events (AEs) to evaluate the safety of ADX-097
Time Frame: 42 weeks
Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G
Secondary Outcomes
- Change from baseline in urine protein-to-creatinine ratio (uPCR)(26 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR)(26 weeks)
Study Sites (5)
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