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RecruitingNCT07541287Updated Sep 25, 2026

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

A Phase 2 interventional study of JADE101 in IgA Nephropathy, sponsored by Jade Biosciences, Inc.. Recruiting at 20 sites in 5 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Jade Biosciences, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • IgA Nephropathy

Keywords

  • Glomerulonephritis
  • Nephritis
  • Nephropathy
  • Kidney Diseases
  • Urologic Diseases
  • Urogenital Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Proteinuria
  • Glomerulonephritis, IGA
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    JADE101

    Subcutaneous (SC) injection of JADE101

    Drug: JADE101

Interventions

  • DrugJADE101

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: Day 1 through 100 weeks

06

Study locations

20 of 20 sites recruiting
  • Jade Clinical Site
    Chula Vista, California 91910, United States
    Recruiting
  • Jade Clinical Site
    Arvada, Colorado 80002, United States
    Recruiting
  • Jade Clinical Site
    Denver, Colorado 80220, United States
    Recruiting
  • Jade Clinical Site
    Orlando, Florida 32806, United States
    Recruiting
  • Jade Clinical Site
    Pembroke Pines, Florida 33029, United States
    Recruiting
  • Jade Clinical Site
    Houston, Texas 77099, United States
    Recruiting
  • Jade Clinical Site
    Concord, New South Wales 2138, Australia
    Recruiting
  • Jade Clinical Site
    Liverpool, New South Wales 2170, Australia
    Recruiting
  • Jade Clinical Site
    Parkville, Victoria 3050, Australia
    Recruiting
  • Jade Clinical Site
    Christchurch, 8011, New Zealand
    Recruiting
  • Jade Clinical Site
    Anyang-si, 14068, South Korea
    Recruiting
  • Jade Clinical Site
    Seongnam-si, 13620, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 03080, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 03722, South Korea
    Recruiting
  • Jade Clinical Site
    Seoul, 06351, South Korea
    Recruiting
  • Jade Clinical Site
    Suwon, 16499, South Korea
    Recruiting
  • Jade Clinical Site
    Taichung, Taichung 404327, Taiwan
    Recruiting
  • Jade Clinical Site
    New Taipei City, Taipei 235041, Taiwan
    Recruiting
  • Jade Clinical Site
    Taipei City, Taipei 110301, Taiwan
    Recruiting
  • Jade Clinical Site
    Taipei, Taipei 100225, Taiwan
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07541287
Lead sponsor
Jade Biosciences, Inc.
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
May 19, 2026
Primary completion
Jan 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

JADE101 Study Contact
Contact
JADE101clinicaltrials@jadebiosciences.com
+1 781 201 4703
Li Li, MD
study director · Jade BioSciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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