A Phase 2 Study of JADE101 in Participants With Immunoglobulin A Nephropathy

NCT07541287 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: JADE101-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of JADE101 in participants with IgA nephropathy

  Incidence of treatment-emergent adverse events

  Day 1 through 100 weeks

Secondary Outcomes (1)

• Effect of JADE101 on UPCR in participants with IgA nephropathy

  Day 1 through 100 weeks

Study Arms (1)

JADE101

EXPERIMENTAL

Subcutaneous (SC) injection of JADE101

Drug: JADE101

Interventions

JADE101 DRUG

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

JADE101

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jade Biosciences, Inc.: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Li, MD

  Jade BioSciences

  STUDY DIRECTOR

Central Study Contacts

JADE101 Study Contact

CONTACT

+1 781 201 4703; JADE101clinicaltrials@jadebiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share