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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004795-34 | EudraCT Number | ||
| U1111-1269-7356 | Other Identifier | Universal Trial Number (UTN) |
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An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.
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This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions. |
|
| Arm B | Experimental | AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-1501 | Drug | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - change in participants UPCR | The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks | Up to 24 weeks |
| Safety- Number of participants with treatment related adverse events | Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI) | Through study completion, an average of 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eGFR slope | The change in eGFR slope from baseline to 96 weeks | Baseline- 96 weeks |
| Change in urine protein excretion (mg/mg) | The change in urine protein excretion over time |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory- Change in baseline serum biomarkers | The change in serum biomarkers from baseline to completion of study | Through study completion, an average of 100 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | South Wales | NSW 2170 | Australia | ||
| Monash Medical Centre |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2024 | |
| Reset | Sep 19, 2024 |
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| Up to 96 weeks |
| Development of Anti drug Antibodies (ADAs) | The percentage of participants who develop ADAs | Up to 96 weeks |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Western Health | St Albans | Victoria | Australia |
| University Hospital Centre Sisters of Charity | Zagreb | Croatia |
| University Hospital Dubrava Zagreb | Zagreb | Croatia |
| University Malaya Medical Centre (UMMC) | Kuala Lumpur | Kuala Lumpur WP | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan (HTAA) | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Queen Elizabeth | Kota Kinabalu | Sabah | Malaysia |
| Hospital Kajang | Kajang | Selangor | 43000 | Malaysia |
| Hospital Serdang | Kajang | Selangor | 43000 | Malaysia |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| Hawke's Bay Hospital | Hastings | 4120 | New Zealand |
| University of Santo Tomas Hospital | Sampaloc | Manila | Philippines |
| Medical University of Bialystok UI | Bialystok | Poland |
| Specjalistyczne Centrum Medyczne, SCM Spółka | Krakow | Poland |
| Hospital de Sagunto | Sagunto | Valencia | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Virgen de la Macarena | Seville | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| National Hospital of Sri Lanka | Colombo | 01000 | Sri Lanka |
| Sri Jayawardanepura General Hospital | Nugegoda | 10250 | Sri Lanka |
| Prince of Songkla University | Dusit | Bangkok | Thailand |
| Chulalongkorn University | Pathum Wan | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | Thailand |
| Chiang Mai University | Chiang Mai | Thailand |
| Kings College Hospital | Camberwell | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2024 | Sep 19, 2024 |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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