A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants with IgAN, LN or C3G
- Conditions
- Lupus Nephritis (LN)C3 (Complement Component 3) GlomerulopathyIgA Nephropathy
- Interventions
- Drug: ADX-097
- Registration Number
- NCT06419205
- Lead Sponsor
- Q32 Bio Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label ADX-097 Subcutaneous Infusions
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) to evaluate the safety of ADX-097 42 weeks Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G
- Secondary Outcome Measures
Name Time Method Change from baseline in urine protein-to-creatinine ratio (uPCR) 26 weeks To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G
Change from baseline in estimated glomerular filtration rate (eGFR) 26 weeks To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G
Trial Locations
- Locations (5)
Denver
🇺🇸Denver, Colorado, United States
Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Las Vegas
🇺🇸Las Vegas, Nevada, United States
New York
🇺🇸New York City, New York, United States
Columbus
🇺🇸Columbus, Ohio, United States