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RecruitingNCT07902817Updated Nov 3, 2026

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

A Phase 3 interventional study of JADE101 and Placebo in IgA Nephropathy (IgAN), sponsored by Jade Biosciences, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Jade Biosciences, Inc. · Phase 3, Interventional, and Treatment

Updated Nov 3, 2026Now RecruitingFirst site in United States+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • IgA Nephropathy (IgAN)

Keywords

  • Glomerulonephritis
  • Nephritis
  • Nephropathy
  • Kidney Diseases
  • Urologic Diseases
  • Urogenital Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Proteinuria
  • Glomerulonephritis, IGA
03

In context

Glomerulonephritis, IGA

266 studies on the registry are indexed under Glomerulonephritis, IGA; 105 are open to participants now.

This study's planned enrollment of 480 is above the median of 68 across 216 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Jade Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    JADE101 Q8W

    Subcutaneous (SC) injection of JADE101 with Q8W maintenance dosing

    Drug: JADE101

  • Experimental
    JADE101 Q12W

    Subcutaneous (SC) injection of JADE101 with Q12W maintenance dosing

    Drug: JADE101

  • Placebo comparator
    Placebo

    Subcutaneous (SC) injection of placebo during the placebo-controlled treatment period

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. To evaluate the effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy

    Change from baseline in UPCR

    Time frame: Week 52

Secondary outcomes

  1. To evaluate the effect of JADE101 on Estimated Glomerular Filtration Rate (eGFR) in participants with IgA nephropathy

    Change from baseline in eGFR

    Time frame: Week 52

07

Study locations

4 of 4 sites recruiting
  • Jade Clinical Site
    Arvada, Colorado 80002, United States
    Recruiting
  • Jade Clinical Site
    Lauderdale Lakes, Florida 33313, United States
    Recruiting
  • Jade Clinical Site
    Atlanta, Georgia 30342, United States
    Recruiting
  • Jade Clinical Site
    Katy, Texas 77494, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2029, 30 months later.

Of 27 phase 3 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 70. This study's planned 30 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2029
CompletionEst.
Sep 2030
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
4 sites added — first site in United States
Show 4 added (4 United States)
  • Jade Clinical Site · Arvada, United States
  • Jade Clinical Site · Lauderdale Lakes, United States
  • Jade Clinical Site · Atlanta, United States
  • Jade Clinical Site · Katy, United States
Nov 3, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    4 sites added — first site in United States
    Show 4 added (4 United States)
    • Jade Clinical Site · Arvada, United States
    • Jade Clinical Site · Lauderdale Lakes, United States
    • Jade Clinical Site · Atlanta, United States
    • Jade Clinical Site · Katy, United States
    + 1 other change: identifiers
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902817
Lead sponsor
Jade Biosciences, Inc.
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Sep 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

JADE101 Study Contact
Contact
JADE101clinicaltrials@jadebiosciences.com
+1 781-201-4703
Li Li, MD
study director · Jade Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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