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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419205
• Other study ID #: ADX-097-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Q32 Bio Inc.
• Contact: Bhavya Haria
• Phone: 6173096647
• Email: bharia[@]q32bio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Male or female participants aged =18 years.

2. Urine protein >0.75 g/24 hours or uPCR >0.75 g/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, LN or C3G obtained within 26 weeks of Day 1.

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Lupus Nephritis
• Nephritis

Intervention

Drug:
• ADX-097
Open Label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Q32 Bio Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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