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The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-623 high dose weekly | Experimental |
| |
| A-623 low dose weekly | Experimental |
| |
| A-623 high dose every 4 weeks | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-623 | Drug | High dose given subcutaneously once a week for up to 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SLE response | The % of subjects with SLE response compared with baseline at the time of assessment | Various timepoints through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| B cell reduction | Various timepoints through Week 52 | |
| Time to first flare | Various timepoints through Week 52 | |
| FACIT-fatigue score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 103 | Birmingham | Alabama | 35294 | United States | ||
| Investigator Site 113 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. | |
| 24748629 | Derived | Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19. |
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| A-623 |
| Drug |
Low dose given subcutaneously once a week for up to 52 weeks |
|
| A-623 | Drug | High dose given subcutaneously once every 4 weeks for up to 52 weeks |
|
| Placebo Comparator | Other | Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks |
|
| Various timepoints through Week 52 |
| Reduction in prednisone dose | Various timepoints through Week 52 |
| Change in IgG, IgM,C3 and C4 | Various timepoints through Week 52 |
| Flare rates | Various timepoints through Week 52 |
| SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 | Various timepoints through Week 52 |
| Long Beach |
| California |
| 90806 |
| United States |
| Investigator Site 108 | Los Angeles | California | 90095 | United States |
| Investigator Site 110 | Upland | California | 91786 | United States |
| Investigator Site 105 | Orlando | Florida | 32806 | United States |
| Investigator Site 102 | Tampa | Florida | 33614 | United States |
| Investigator Site 117 | Baltimore | Maryland | 21205 | United States |
| Investigator Site 104 | Lansing | Michigan | 48910 | United States |
| Investigator Site 106 | Lake Success | New York | 11042 | United States |
| Investigator Site 114 | Smithtown | New York | 11787 | United States |
| Investigator Site 101 | Greenville | North Carolina | 27834 | United States |
| Investigator Site 112 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigator Site 111 | Tulsa | Oklahoma | 74104 | United States |
| Investigator Site 115 | Houston | Texas | 77034 | United States |
| Investigator Site 404 | Caba | Buenos Aires | C1015ABO | Argentina |
| Investigator Site 402 | Caba | Buenos Aires | C1280AEB | Argentina |
| Investigator Site 408 | San Juan | San Juan Province | 5400 | Argentina |
| Investigator Site 403 | Rosario | Santa Fe Province | S2000PBJ | Argentina |
| Investigator Site 406 | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Investigator Site 407 | Buenos Aires | C1121ABE | Argentina |
| Investigator Site 401 | Buenos Aires | C1431FWO | Argentina |
| Investigator Site 504 | Salvador | Estado de Bahia | 40050-010 | Brazil |
| Investigator Site 509 | Goiás | Goiania | 74605-050 | Brazil |
| Investigator Site 507 | Goiânia | Goiás | 74110120 | Brazil |
| Investigator Site 506 | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Investigator Site 512 | Porto Alegre | Rio de Grande Do Sul | 90035-903 | Brazil |
| Investigator Site 503 | Rio de Janeiro | Rio de Janeiro | 21941 | Brazil |
| Investigator Site 502 | Porto Alegre | Rio Grande do Sul | 9061-0000 | Brazil |
| Investigator Site 510 | Campinas | São Paulo | 13015 | Brazil |
| Investigator Site 505 | São Paulo | São Paulo | 04038-004 | Brazil |
| Investigator Site 501 | São Paulo | São Paulo | 04039-901 | Brazil |
| Investigator Site 511 | Rio de Janeiro | 20551 | Brazil |
| Investigator Site 606 | Santiago | Chile | Chile |
| Investigator Site 602 | Santiago | 8330033 | Chile |
| Investigator Site 605 | Santiago | Chile |
| Investigator Site 601 | Viña del Mar | 2570017 | Chile |
| Investigator Site 706 | Medellín | Antioquia | Colombia |
| Investigator Site 710 | Medellín | Antioquia | Colombia |
| Investigator Site 701 | Barranquilla | Atlántico | Colombia |
| Investigator Site 704 | Barranquilla | Atlántico | Colombia |
| Investigator Site 703 | Bogota | Cundinamarca | Colombia |
| Investigator Site 707 | Bucaramanga | Santander Department | Colombia |
| Investigator Site 702 | Bogotá | Colombia |
| Investigator Site 705 | Bogotá | Colombia |
| Investigator Site 709 | Bogotá | Colombia |
| Investigator Site 711 | Bucaramanga | Colombia |
| Investigator Site 708 | Medellín | Colombia |
| Investigator Site 153 | New Territories | Shatin | Hong Kong |
| Investigator Site 151 | Hong Kong | Hong Kong |
| Investigator Site 205 | Secunderabad | Andhra Pradesh | 500003 | India |
| Investigator Site 203 | Bangalore | Kamataka | 560034 | India |
| Investigator Site 204 | Trivandrum | Kerala | 695011 | India |
| Investigator Site 201 | Mumbai | Maharashtra | 400012 | India |
| Investigator Site 803 | Mexico City | D.f. | 06726 | Mexico |
| Inestigator Site 809 | México | D.f. | 14000 | Mexico |
| Investigator Site 806 | Guadalajara | Jalisco | 44280 | Mexico |
| Investigator Site 804 | Morelia | Michoacán | 58070 | Mexico |
| Investigator Site 801 | San Luis Potosí City | San Luis Potosí | 78240 | Mexico |
| Investigator Site 802 | Toluca | State of Mexico | 50120 | Mexico |
| Investigator Site 808 | Guanajuato City | Mexico |
| Investigator Site 805 | México | Mexico |
| Investigator Site 807 | México | Mexico |
| Investigator Site 901 | Cayma | Arequipa | Peru |
| Investigator Site 903 | Lima | Lima Province | L-01 | Peru |
| Investigator Site 905 | Lima | Lima Province | L27 | Peru |
| Investigator Site 904 | Lima | Lima Province | Peru |
| Investigator Site 902 | Bellavista Callao | Provincia Constitucional del Callao | Peru |
| Investigator Site 302 | Cebu | Cebu | 6000 | Philippines |
| Investigator Site 303 | Davao City | Davao Region | 8000 | Philippines |
| Investigator Site 304 | Manila | National Capital Region | 1008 | Philippines |
| Investigator Site 305 | Davao City | 8000 | Philippines |
| Investigator Site 354 | Taichung | 402 | Taiwan |
| Investigator Site 352 | Taichung | 414 | Taiwan |
| Investigator Site 351 | Taipei | 100 | Taiwan |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C573858 | AMG623 peptibody |
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