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NCT Number: NCT07541287

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jade Clinical Site, Christchurch, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

JADE101

Drug

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

Primary outcomes

  1. Incidence of treatment-emergent adverse events (safety and tolerability)

    Time frame: Day 1 through 100 weeks

    The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug

Secondary outcomes

  1. Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy

    Time frame: Day 1 through 100 weeks

    Change from baseline in UPCR

Study contacts

Contact information is provided by the study sponsor or research team.

JADE101 Study Contact

CONTACT

[email protected]

+1 781 201 4703

Sponsors and collaborators

Lead sponsor

Jade Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 21, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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