A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants with IgAN, LN or C3G

Launched by Q32 BIO INC. · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ADX-097 for patients with specific kidney conditions: IgA Nephropathy (IgAN), Lupus Nephritis (LN), or C3 Glomerulopathy (C3G). The main goals are to see how safe the treatment is, how it works in the body, and whether it helps improve kidney health. The trial is open to men and women aged 18 and older who meet certain health criteria, such as having a specific level of protein in their urine and having a certain level of kidney function. Participants need to have a confirmed diagnosis of one of these kidney diseases from a recent kidney biopsy.

Those who join the trial can expect to receive the treatment through injections under the skin and will be monitored closely for safety and effectiveness. It's important to know that participants should have stable kidney health and be on certain medications at a consistent dose for at least 12 weeks before starting the trial. This study is currently recruiting participants, so if you think you might qualify and are interested in contributing to the research, it could be a valuable opportunity.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or female participants aged ≥18 years.
• • 2. Urine protein ≥ 0.75 g/24 hours or uPCR ≥ 0.5g/g
• • 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
• • 4. 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.
• • 5. 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.
• • 6. 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
• • 1. A ≥50% decline in eGFR within 3 months before screening.
• • 2. Concomitant significant renal disease other than IgAN, C3G, or LN.
• • 3. Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment.
• • 4. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.