IgA NephropathyPhase 2NCT07541287
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
A Phase 2 study testing JADE101 in people with IgA Nephropathy, run by Jade Biosciences, Inc. at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- JADE101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 19 May 2026to Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent
- eGFR ≥ 30 mL/min/1.73 m2
- Biopsy-confirmed primary IgAN
- 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
- UPCR ≥ 0.75 g/g
- Willing to provide written informed consent
- Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures
- Willing and able to comply with contraceptive and lifestyle requirements
Who cannot join
- Secondary forms of IgAN
- Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
- Known or suspected rapidly progressive glomerulonephritis (RPGN)
- 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
- Known or suspected primary or secondary immunodeficiency disorder
- Evidence of tuberculosis infection at screening
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- Any chronic infectious disease
- Any acute infectious disease at time of screening
- Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney
- Known or suspected alcohol or drug abuse
- Any clinically significant and/or unstable or uncontrolled medical condition as assessed by the investigator
- 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
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States6 sites, 6 recruiting
- Recruiting
Jade Clinical Site
Arvada, Colorado, 80002
- Recruiting
Jade Clinical Site
Chula Vista, California, 91910
- Recruiting
Jade Clinical Site
Denver, Colorado, 80220
- Recruiting
Jade Clinical Site
Houston, Texas, 77099
- Recruiting
Jade Clinical Site
Orlando, Florida, 32806
- Recruiting
Jade Clinical Site
Pembroke Pines, Florida, 33029
South Korea6 sites, 6 recruiting
- Recruiting
Jade Clinical Site
Anyang-si, 14068
- Recruiting
Jade Clinical Site
Seongnam-si, 13620
- Recruiting
Jade Clinical Site
Seoul, 03080
- Recruiting
Jade Clinical Site
Seoul, 03722
- Recruiting
Jade Clinical Site
Seoul, 06351
- Recruiting
Jade Clinical Site
Suwon, 16499
Taiwan4 sites, 4 recruiting
- Recruiting
Jade Clinical Site
New Taipei City, Taipei, 235041
- Recruiting
Jade Clinical Site
Taichung, Taichung, 404327
- Recruiting
Jade Clinical Site
Taipei, Taipei, 100225
- Recruiting
Jade Clinical Site
Taipei City, Taipei, 110301
Australia3 sites, 3 recruiting
- Recruiting
Jade Clinical Site
Concord, New South Wales, 2138
- Recruiting
Jade Clinical Site
Liverpool, New South Wales, 2170
- Recruiting
Jade Clinical Site
Parkville, Victoria, 3050
New Zealand1 site, 1 recruiting
- Recruiting
Jade Clinical Site
Christchurch, 8011
About this study
Official title: A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)
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.
- Conditions
- IgA Nephropathy
- Being tested
- JADE101
- Keywords
- Glomerulonephritis, Nephritis, Nephropathy, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases, Proteinuria, Glomerulonephritis, IGA
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulonephritis, Nephritis, Kidney Diseases, Urologic Diseases, Urogenital Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADE101Drug
JADE101 is supplied as sterile solution to be administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| JADE101 | Experimental | Subcutaneous (SC) injection of JADE101 Receives: Drug: JADE101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety and tolerability)
The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug
Measured: Day 1 through 100 weeks
Secondary outcomes (1)
Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Change from baseline in UPCR
Measured: Day 1 through 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start19 May 2026
- Primary completionJan 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jade Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Study director, Jade BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541287
- Sponsor's protocol ID
- JADE101-02
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No