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

NCT06419205 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: ADX-097-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in urine protein-to-creatinine ratio (uPCR)

  26 weeks

• Change from baseline in estimated glomerular filtration rate (eGFR)

  26 weeks

Study Arms (1)

Open Label

OTHER

Subcutaneous Infusions

Drug: ADX-097

Interventions

ADX-097 DRUG

Open Label

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Q32 Bio Inc.: lead

Study Sites (5)

Denver

Denver, Colorado, 00000, United States

Location

Minneapolis

Minneapolis, Minnesota, 00000, United States

Location

Las Vegas

Las Vegas, Nevada, 00000, United States

Location

New York

New York, New York, 00000, United States

Location

Columbus

Columbus, Ohio, 00000, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Lupus Nephritis; Complement Component 3 Deficiency, Autosomal Recessive

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 17, 2024
• Study Start: June 27, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)