What this study is
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.
What's being tested
- JADE101
Intervention · DRUG
JADE101 is supplied as sterile solution to be administered by SC injection
Study details
- Official title
- A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)
- Sponsor
- Jade Biosciences, Inc.
- Conditions
- IgA Nephropathy
- Enrolling
- 30 people
- Starts
- 2026-05-19
- Est. completion
- 2029-04
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (22)
22 openJade Clinical Site
Chula Vista, California, United States
RecruitingJade Clinical Site
Arvada, Colorado, United States
RecruitingJade Clinical Site
Denver, Colorado, United States
RecruitingJade Clinical Site
Orlando, Florida, United States
RecruitingJade Clinical Site
Pembroke Pines, Florida, United States
RecruitingJade Clinical Site
Houston, Texas, United States
Recruiting
16 sites outside the US
Jade Clinical Site
Concord, New South Wales, Australia
RecruitingJade Clinical Site
Liverpool, New South Wales, Australia
RecruitingJade Clinical Site
Parkville, Victoria, Australia
RecruitingJade Clinical Site
Christchurch, New Zealand
RecruitingJade Clinical Site
Anyang-si, South Korea
RecruitingJade Clinical Site
Seongnam-si, South Korea
RecruitingJade Clinical Site
Seoul, South Korea
RecruitingJade Clinical Site
Seoul, South Korea
RecruitingJade Clinical Site
Seoul, South Korea
RecruitingJade Clinical Site
Suwon, South Korea
RecruitingJade Clinical Site
Kaohsiung City, Kaohsiung, Taiwan
RecruitingJade Clinical Site
Taichung, Taichung, Taiwan
RecruitingJade Clinical Site
New Taipei City, Taipei, Taiwan
RecruitingJade Clinical Site
Taipei City, Taipei, Taiwan
RecruitingJade Clinical Site
Taipei, Taipei, Taiwan
RecruitingJade Clinical Site
Taiyuan, Taoyuan, Taiwan
Recruiting
Study team
Sponsor
Jade Biosciences, Inc.
Study ID JADE101-02
Study director
Li Li, MD
Jade BioSciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.