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

Phase 2

Recruiting

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

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-17
• Study Start: 2024-06-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

Not provided

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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