A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
Purpose
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.
Condition
- IgA Nephropathy
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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/exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JADE101 |
Subcutaneous (SC) injection of JADE101 |
|
Recruiting Locations
Jade Clinical Site
Chula Vista, California 91910
Chula Vista, California 91910
Jade Clinical Site
Arvada, Colorado 80002
Arvada, Colorado 80002
Jade Clinical Site
Denver, Colorado 80220
Denver, Colorado 80220
Jade Clinical Site
Orlando, Florida 32806
Orlando, Florida 32806
Jade Clinical Site
Pembroke Pines, Florida 33029
Pembroke Pines, Florida 33029
Jade Clinical Site
Houston, Texas 77099
Houston, Texas 77099
More Details
- Status
- Recruiting
- Sponsor
- Jade Biosciences, Inc.