WithdrawnPhase 2

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

Stopped: study closed prior to enrolling any patients.

United States0Started 2024-06-27

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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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.

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.

What they're measuring

Incidence of adverse events (AEs) to evaluate the safety of ADX-097

Timeframe: 42 weeks

Trial details

NCT IDNCT06419205

SponsorQ32 Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

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