A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of JADE101 Administered Subcutaneously in Participants With Immunoglobulin A Nephropathy (The EVERGREEN Study)
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN). The results will contribute to the overall clinical characterization of JADE101 in this patient population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: JADE101 Study Contact
- Phone Number: +1 781-201-4703
- Email: JADE101clinicaltrials@jadebiosciences.com
Study Locations
-
-
Colorado
-
Arvada, Colorado, United States, 80002
- Recruiting
- Jade Clinical Site
-
-
Florida
-
Lauderdale Lakes, Florida, United States, 33313
- Recruiting
- Jade Clinical Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Jade Clinical Site
-
-
Texas
-
Katy, Texas, United States, 77494
- Recruiting
- Jade Clinical Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult participants with biopsy-confirmed primary IgAN.
- UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample.
- eGFR ≥30 mL/min/1.73 m².
- Stable and maximally tolerated doses of ACEi and/or ARB according to standard of care and applicable guidelines for at least 12 weeks prior to the initial screening visit.
Exclusion Criteria:
-
Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment.
-
Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
-
Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).
-
Body weight <40 kg or morbid obesity.
-
Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
-
Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy.
- Anti-APRIL biologics
- Anti-CD38 therapy
- Anti-CD20 therapy
-
Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening.
-
Presence of or history of nephrotic syndrome, defined as 24-hour urine protein >3.5 g/day with concurrent hypoalbuminemia.
-
Serum IgG level <6 g/L (<600 mg/dL).
Other protocol-defined inclusion and exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: JADE101 Q8W
Subcutaneous (SC) injection of JADE101 with Q8W maintenance dosing |
JADE101 is supplied as sterile solution to be administered by SC injection. |
|
Experimental: JADE101 Q12W
Subcutaneous (SC) injection of JADE101 with Q12W maintenance dosing |
JADE101 is supplied as sterile solution to be administered by SC injection. |
|
Placebo Comparator: Placebo
Subcutaneous (SC) injection of placebo during the placebo-controlled treatment period |
Placebo 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 |
|---|---|---|
|
To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Time Frame: Week 52
|
Change from baseline in UPCR |
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effect of JADE101 on Estimated Glomerular Filtration Rate (eGFR) in participants with IgA nephropathy
Time Frame: Week 52
|
Change from baseline in eGFR |
Week 52
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Li Li, MD, Jade Biosciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- JADE101-03
- 2026-527177-11-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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