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Monoclonal Antibodies
ADX-097 for Immunoglobulin A Nephropathy
Phase 2
Recruiting
Research Sponsored by Q32 Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
Male or female participants aged ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new drug called ADX-097 in male and female participants aged 18 years or older who have certain kidney diseases. The study will look at the safety, how the drug
Who is the study for?
This trial is for adults over 18 with certain kidney conditions: IgAN, LN, or C3G. They should have protein in their urine and a minimum kidney function level. Participants must be on stable doses of specific medications for at least 12 weeks before the study starts.
What is being tested?
The trial tests ADX-097, administered subcutaneously (under the skin), to assess its safety and effectiveness in treating IgAN, LN, or C3G. It will also look at how the body processes the drug.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at injection sites, changes in kidney function tests, allergic responses or other immune system-related events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been on a stable dose of a RAAS inhibitor for at least 12 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events (AEs) to evaluate the safety of ADX-097
Secondary study objectives
Change from baseline in estimated glomerular filtration rate (eGFR)
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Subcutaneous Infusions
Find a Location
Who is running the clinical trial?
Q32 Bio Inc.Lead Sponsor
3 Previous Clinical Trials
184 Total Patients Enrolled