IgA Nephropathy
Conditions
Keywords
Glomerulonephritis, Nephritis, Nephropathy, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases, Proteinuria, Glomerulonephritis, IGA
Brief summary
This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.
Interventions
DRUGJADE101
JADE101 is supplied as sterile solution to be administered by SC injection
Sponsors
Jade Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent 2. eGFR ≥ 30 mL/min/1.73 m2 3. Biopsy-confirmed primary IgAN 4. Receiving stable and maximally tolerated doses of either ACEi or ARB as per standard of care (SoC) and applicable guidelines for at least 12 weeks prior to the initial screening visit, with no intention to alter the dose or discontinue treatment, unless medically necessary 5. UPCR ≥ 0.75 g/g 6. Willing to provide written informed consent 7. Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures 8. Willing and able to comply with contraceptive and lifestyle requirements
Exclusion criteria
1. Secondary forms of IgAN 2. Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN 3. Known or suspected rapidly progressive glomerulonephritis (RPGN) 4. Evidence of pathological findings in the kidney biopsy in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); hypertensive vascular changes are acceptable 5. Known or suspected primary or secondary immunodeficiency disorder 6. Evidence of tuberculosis infection at screening 7. Any chronic infectious disease 8. Any acute infectious disease at time of screening 9. Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney 10. Known or suspected alcohol or drug abuse 11. Any clinically significant and/or unstable or uncontrolled medical condition as assessed by the investigator 12. Malignancy within the past 5 years; nonmelanoma skin cancer and curatively treated cervical carcinoma in situ are allowed Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | Day 1 through 100 weeks | The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy | Day 1 through 100 weeks | Change from baseline in UPCR |
Countries
Australia, New Zealand, South Korea, Taiwan, United States
Contacts
CONTACTJADE101 Study Contact
STUDY_DIRECTORLi Li, MD
Jade BioSciences
Outcome results
None listed