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

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Status and phase: Withdrawn; Phase 2

Conditions: C3 (Complement Component 3) Glomerulopathy; Lupus Nephritis (LN); IgA Nephropathy

Treatments: Drug: ADX-097

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419205

ADX-097-201

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Open Label

Other group

Description:

Subcutaneous Infusions

Treatment:

Drug: ADX-097