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

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 IgAN, LN, or C3G

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)

Study Overview

• Status: Withdrawn
• Conditions: IgA Nephropathy; Lupus Nephritis (LN); C3 (Complement Component 3) Glomerulopathy
• Intervention / Treatment: Drug: ADX-097

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 00000
      • Denver
  • Minnesota
    • Minneapolis, Minnesota, United States, 00000
      • Minneapolis
  • Nevada
    • Las Vegas, Nevada, United States, 00000
      • Las Vegas
  • New York
    • New York City, New York, United States, 00000
      • New York
  • Ohio
    • Columbus, Ohio, United States, 00000
      • Columbus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open Label; Subcutaneous Infusions	Drug: ADX-097; Open Label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) to evaluate the safety of ADX-097	Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G	42 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in urine protein-to-creatinine ratio (uPCR)	To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G	26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)	To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G	26 weeks

Collaborators and Investigators

• Sponsor: Q32 Bio Inc.

Publications and helpful links

Helpful Links

• Study Website Link

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: ADX-097-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No