Clinical trial NCT06419205: A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: IgA Nephropathy
Lupus Nephritis (LN)
C3 (Complement Component 3) Glomerulopathy
Lead sponsor: Q32 Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)


Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) to evaluate the safety of ADX-097
timeFrame: 42 weeks
Secondary outcomes:
measure: Change from baseline in urine protein-to-creatinine ratio (uPCR)
timeFrame: 26 weeks
measure: Change from baseline in estimated glomerular filtration rate (eGFR)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver
state: Colorado
city: Minneapolis
country: United States
facility: Minneapolis
state: Minnesota
city: Las Vegas
country: United States
facility: Las Vegas
state: Nevada
city: New York City
country: United States
facility: New York
state: New York
city: Columbus
country: United States
facility: Columbus
state: Ohio
Study officials:
References: