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Clinical Trials in the USA / NCT07541287
Recruiting Phase 2

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

NCT07541287 · tracked via the Priya Life Science USA tracker
Sponsor
Jade Biosciences, Inc.
Phase
Phase 2
Started
2026-05-19
Last updated
2026-08-20

Condition(s) studied

IgA Nephropathy

Investigational drug(s) / intervention(s)

JADE101

JADE101: JADE101 is supplied as sterile solution to be administered by SC injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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/exclusion criteria may apply

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Jade Clinical Site Chula Vista California Recruiting
Jade Clinical Site Arvada Colorado Recruiting
Jade Clinical Site Denver Colorado Recruiting
Jade Clinical Site Orlando Florida Recruiting
Jade Clinical Site Pembroke Pines Florida Recruiting
Jade Clinical Site Houston Texas Recruiting
Jade Clinical Site Concord New South Wales Recruiting
Jade Clinical Site Christchurch New Zealand Recruiting
Jade Clinical Site Anyang-si South Korea Recruiting
Jade Clinical Site Seongnam-si South Korea Recruiting
Jade Clinical Site Seoul South Korea Recruiting
Jade Clinical Site Seoul South Korea Recruiting
Jade Clinical Site Seoul South Korea Recruiting
Jade Clinical Site Suwon South Korea Recruiting
Jade Clinical Site Taipei Taiwan Recruiting

More Jade Biosciences, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07541287 on ClinicalTrials.gov ↗ ← All trials in the USA