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This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atacicept Arm 1 | Experimental | Atacicept dose A administered subcutaneous (sc) injection monthly |
|
| Atacicept Arm 2 | Experimental | Atacicept dose B administered subcutaneous (sc) injection monthly | |
| Atacicept Arm 3 | Experimental | Atacicept dose C administered subcutaneous (sc) injection monthly | |
| Atacicept Arm 4 | Experimental | Atacicept dose D administered subcutaneous (sc) injection weekly | |
| Atacicept Arm 5 | Experimental | Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atacicept | Drug | Drug: Atacicept |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN | Gd-IgA1 levels through Week 24 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of atacicept at different dosing regimensT | Incidence of treatment emergent reported Adverse Events (AE) | Baseline until end of study up to Week 24 |
| To evaluate the effect of atacicept on serum immunoglobulins (IgA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeeshan Khawaja | Vice President, Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vera Therapeutics | Brisbane | California | 94005 | United States |
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| Label | URL |
|---|---|
| Vera Therapeutics, Inc Company Website | View source |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C524618 | TACI receptor-IgG Fc fragment fusion protein |
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IgA levels through Week 24 |
| 24 Weeks |
| To evaluate the effect of atacicept on serum immunoglobulins (IgG) | IgG levels through Week 24 | 24 Weeks |
| To evaluate the effect of atacicept on serum immunoglobulins (IgM) | IgM levels through Week 24 | 24 Weeks |
| To evaluate serum PK of atacicept | Serum concentration of atacicept | Baseline until end of study up to Week 24 |
| 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 |