A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

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.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: JADE101

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JADE101 Study Contact; Phone Number: +1 781 201 4703; Email: JADE101clinicaltrials@jadebiosciences.com

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Recruiting
    • Jade Clinical Site
• United States
  • California
    • Chula Vista, California, United States, 91910
      • Recruiting
      • Jade Clinical Site
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Recruiting
      • Jade Clinical Site
    • Denver, Colorado, United States, 80220
      • Recruiting
      • Jade Clinical Site
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Jade Clinical Site
    • Pembroke Pines, Florida, United States, 33029
      • Recruiting
      • Jade Clinical Site
  • Texas
    • Houston, Texas, United States, 77099
      • Recruiting
      • Jade Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JADE101; Subcutaneous (SC) injection of JADE101	Drug: JADE101; JADE101 is supplied as sterile solution to be administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 through 100 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy	Change from baseline in UPCR	Day 1 through 100 weeks

Collaborators and Investigators

• Sponsor: Jade Biosciences, Inc.
• Investigators: Study Director: Li Li, MD, Jade Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Kidney Diseases; Proteinuria; Nephritis; Glomerulonephritis; Nephropathy; Glomerulonephritis, IGA; Urogenital Diseases
• Additional Relevant MeSH Terms: Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urogenital Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Autoimmune Diseases; Kidney Diseases; Glomerulonephritis, IGA; Immune System Diseases; Proteinuria
• Other Study ID Numbers: JADE101-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No