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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: JADE101 Study Contact
- Telefonnummer: +1 781-201-4703
- E-mail: JADE101clinicaltrials@jadebiosciences.com
Studiesteder
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-
Colorado
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Arvada, Colorado, Forenede Stater, 80002
- Rekruttering
- Jade Clinical Site
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Florida
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Lauderdale Lakes, Florida, Forenede Stater, 33313
- Rekruttering
- Jade Clinical Site
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-
Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Rekruttering
- Jade Clinical Site
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Texas
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Katy, Texas, Forenede Stater, 77494
- Rekruttering
- Jade Clinical Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
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Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
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Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).
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Body weight <40 kg or morbid obesity.
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Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
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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
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Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening.
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Presence of or history of nephrotic syndrome, defined as 24-hour urine protein >3.5 g/day with concurrent hypoalbuminemia.
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Serum IgG level <6 g/L (<600 mg/dL).
Other protocol-defined inclusion and exclusion criteria may apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: JADE101 Q8W
Subcutaneous (SC) injection of JADE101 with Q8W maintenance dosing |
JADE101 is supplied as sterile solution to be administered by SC injection. |
|
Eksperimentel: JADE101 Q12W
Subcutaneous (SC) injection of JADE101 with Q12W maintenance dosing |
JADE101 is supplied as sterile solution to be administered by SC injection. |
|
Placebo komparator: Placebo
Subcutaneous (SC) injection of placebo during the placebo-controlled treatment period |
Placebo is supplied as sterile solution to be administered by SC injection. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Tidsramme: Week 52
|
Change from baseline in UPCR |
Week 52
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the effect of JADE101 on Estimated Glomerular Filtration Rate (eGFR) in participants with IgA nephropathy
Tidsramme: Week 52
|
Change from baseline in eGFR |
Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Li Li, MD, Jade Biosciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Mandlige urogenitale sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Vandladningsforstyrrelser
- Urologiske manifestationer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Urogenitale sygdomme
- Urologiske sygdomme
- Nefritis
- Glomerulonefritis
- Autoimmune sygdomme
- Nyresygdomme
- Glomerulonefritis, IGA
- Sygdomme i immunsystemet
- Proteinuri
Andre undersøgelses-id-numre
- JADE101-03
- 2026-527177-11-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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