Recruiting
Phase 2

JADE101

Sponsor:

Jade Biosciences, Inc.

Code:

NCT07541287

Conditions

IgA Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

JADE101

Study Details

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.

Conditions

IgA Nephropathy

Study ID

NCT07541287

Start date

May 19, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JADE101

Subcutaneous (SC) injection of JADE101

Interventions

JADE101

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

Primary outcome measure

  • Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Day 1 through 100 weeks ]

Central Contacts and Locations

Locations

Jade Clinical Site

Recruiting

Chula Vista, California, United States, 91910

Jade Clinical Site

Recruiting

Arvada, Colorado, United States, 80002

Jade Clinical Site

Recruiting

Denver, Colorado, United States, 80220

Jade Clinical Site

Recruiting

Orlando, Florida, United States, 32806

Jade Clinical Site

Recruiting

Pembroke Pines, Florida, United States, 33029

Jade Clinical Site

Recruiting

Houston, Texas, United States, 77099

More Information

Sponsor

Jade Biosciences, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jade Biosciences, Inc. on 2026-08-20.