Ireland
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Recruiting Phase 3

A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy

NCT07902817 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-12
Last updated
2026-11-03

Condition(s) studied

IgA Nephropathy (IgAN)

Investigational drug(s) / intervention(s)

JADE101 →Placebo

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

Placebo: Placebo is supplied as sterile solution to be administered by SC injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult participants with biopsy-confirmed primary IgAN. 2. UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample. 3. eGFR ≥30 mL/min/1.73 m². 4. 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: 1. Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment. 2. Known or clinically suspected rapidly progressive glomerulonephritis (RPGN). 3. Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis). 4. Body weight \<40 kg or morbid obesity. 5. Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period. 6. Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy. 1. Anti-APRIL biologics 2. Anti-CD38 therapy 3. Anti-CD20 therapy 7. Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening. 8. Presence of or history of nephrotic syndrome, defined as 24-hour urine protein \>3.5 g/day with concurrent hypoalbuminemia. 9. Serum IgG level \<6 g/L (\<600 mg/dL). Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcome measure(s)

  • To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy — Week 52
    Change from baseline in UPCR

Trial sites (4)

FacilityCityRegionStatus
Jade Clinical Site Arvada Colorado Recruiting
Jade Clinical Site Lauderdale Lakes Florida Recruiting
Jade Clinical Site Atlanta Georgia Recruiting
Jade Clinical Site Katy Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07902817 on ClinicalTrials.gov ↗ ← All trials in the USA