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Clinical Trials List

Protocol NumberJADE101-02
NCT Number(ClinicalTrials.gov Identfier)NCT07541287
Not yet recruiting

2026-08-31 - 2029-05-11

Phase II

Not yet recruiting6

A phase 2, multicenter, open-label trial evaluating the safety and efficacy of JADE101 in participants with immunoglobulin-induced nephropathy (JUNIPER).

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Parexel International Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator - - Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator I-WEN WU Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wen-Chin Lee Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Mei-Yi Wu Division of Nephrology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ping-Chin Lai Division of Nephrology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Guan-Hsing Chen
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Immunoglobulin A nephropathy

Objectives

Primary objective: Evaluate the safety and tolerability of JADE101 in participants with IgAN. Secondary objective: Evaluate the effect of JADE101 on the urinary protein-creatinine ratio (UPCR) in participants with IgAN.

Test Drug

JADE101 Solution for Injection

Active Ingredient

JADE101

Dosage Form

Dosage

Injection

Endpoints

Incidence of treatment-associated adverse events (TEAEs)

Inclution Criteria

- Male or female participants aged 18–60 years (inclusive) at the time of signing the participant consent form, meeting the legal age of consent in their locality.

- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73 m^2

- Source-verified and biopsy-confirmed primary IgAN

- Received a stable and maximally tolerated dose of ACEi or ARB for at least 12 weeks prior to the initial screening visit, following standard of care (SoC) and applicable guidelines, with no plans to change the dose or discontinue treatment unless medically necessary.

- Urine Protein-to-Creatinine Ratio (UPCR) ≥ 0.75 g/g

- Willing to provide written informed consent

- Willing and able to cooperate with scheduled trial visits, treatment plans, laboratory tests, and other trial procedures

- Willing and able to adhere to contraception and lifestyle requirements

Exclusion Criteria

- Secondary forms of IgAN

- Known or clinically suspected coexisting CKD other than IgAN

- Known or clinically suspected rapid progressive glomerulonephritis (RPGN)

- Evidence of pathological findings in kidney sections other than IgAN (e.g., minimal nephropathy, diabetic nephropathy, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); acceptable hypertensive vascular changes

- Known or suspected primary or secondary immunodeficiency disease

- Evidence of active or clinically significant viral infection at screening, defined as meeting any of the following criteria:

• Human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) antibodies

• Hepatitis A virus (HAV) immunoglobulin M • Positive serological test results for IgM and M antibodies

• Positive for hepatitis B surface antigen (HBsAg)

Note: Participants who are HBcAb positive will undergo further testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA); participants who are HBcAb positive will be excluded unless HBsAb is positive and both HBsAg and HBV DNA are negative.

• Positive for hepatitis C virus (HCV) antibody (Ab)

Note: Participants who are HCV Ab positive will undergo further polymerase chain reaction (PCR) testing for HCV ribonucleic acid (RNA). Participants with undetectable HCV RNA may be included:

- Evidence of tuberculosis infection at screening

- Any chronic infectious disease

- Any acute infectious disease at screening

- Previous bone marrow, hematopoietic stem cell, or solid organ transplant, including a kidney transplant

- Known or suspected alcohol or drug abuse

- Any clinically significant and/or unstable or uncontrolled medical condition as assessed by the trial administrator

- History of malignancy within the past 5 years; non-melanoma skin cancer and previously treated cervical carcinoma in situ are permitted

- Receive any prohibited medications during the specified period, or may require concomitant treatment with prohibited medications during the trial

- Participants deemed unsuitable for participation by the trial administrator or medical monitor

The Estimated Number of Participants

  • Taiwan

    8 participants

  • Global

    30 participants

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