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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JADE101 | Experimental | Subcutaneous (SC) injection of JADE101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JADE101 | Drug | JADE101 is supplied as sterile solution to be administered by SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug | Day 1 through 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy | Change from baseline in UPCR | Day 1 through 100 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JADE101 Study Contact | Contact | +1 781 201 4703 | JADE101clinicaltrials@jadebiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Jade BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jade Clinical Site | Recruiting | Chula Vista | California | 91910 | United States | |
| Jade Clinical Site |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D000091642 | Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
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| Recruiting |
| Arvada |
| Colorado |
| 80002 |
| United States |
| Jade Clinical Site | Recruiting | Denver | Colorado | 80220 | United States |
| Jade Clinical Site | Recruiting | Orlando | Florida | 32806 | United States |
| Jade Clinical Site | Recruiting | Pembroke Pines | Florida | 33029 | United States |
| Jade Clinical Site | Recruiting | Houston | Texas | 77099 | United States |
| Jade Clinical Site | Recruiting | Christchurch | 8011 | New Zealand |
| Jade Clinical Site | Recruiting | Seoul | 03722 | South Korea |
| Jade Clinical Site | Recruiting | Seoul | 06351 | South Korea |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |