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Mai","50200",{"type":50,"coordinates":1431},[1432,1433],98.98468,18.79038,{"lat":1433,"lon":1432},{"facility":1436,"status":43,"city":1437,"state":26,"zip":1438,"country":1439,"countryCode":26,"cosmosGeoPoint":1440,"geoPoint":1444,"contacts":26},"Ankara University Medical Faculty","Ankara","06050","Turkey (Türkiye)",{"type":50,"coordinates":1441},[1442,1443],32.85427,39.91987,{"lat":1443,"lon":1442},{"facility":1446,"status":43,"city":1437,"state":26,"zip":1447,"country":1439,"countryCode":26,"cosmosGeoPoint":1448,"geoPoint":1450,"contacts":26},"Ankara Bilkent Sehir Hastanesi","06800",{"type":50,"coordinates":1449},[1442,1443],{"lat":1443,"lon":1442},{"facility":1452,"status":43,"city":1453,"state":26,"zip":1454,"country":1439,"countryCode":26,"cosmosGeoPoint":1455,"geoPoint":1459,"contacts":26},"Firat University 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5LE",{"type":50,"coordinates":1512},[1513,1514],-0.97113,51.45625,{"lat":1514,"lon":1513},{"facility":1517,"status":43,"city":1518,"state":26,"zip":1519,"country":1491,"countryCode":1492,"cosmosGeoPoint":1520,"geoPoint":1524,"contacts":26},"Southampton University Hospital","Southampton","SO16 6HU",{"type":50,"coordinates":1521},[1522,1523],-1.40428,50.90395,{"lat":1523,"lon":1522},{"facility":1526,"status":43,"city":1527,"state":26,"zip":1528,"country":1491,"countryCode":1492,"cosmosGeoPoint":1529,"geoPoint":1533,"contacts":26},"Haywood Hospital","Stoke-on-Trent","ST6 7AG",{"type":50,"coordinates":1530},[1531,1532],-2.18538,53.00415,{"lat":1532,"lon":1531},{"facility":1535,"status":43,"city":1536,"state":26,"zip":1537,"country":1491,"countryCode":1492,"cosmosGeoPoint":1538,"geoPoint":1542,"contacts":26},"Great Western Hospital","Swindon","SN3 6BB",{"type":50,"coordinates":1539},[1540,1541],-1.78116,51.55797,{"lat":1541,"lon":1540},{"type":1544,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626658","phase-3-a-study-of-nipocalimab-in-adults-with-moderate-to-severe-systemic-lupus-erythematosus-100626658",false,"NCT07438496","A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","GARDENIA","Inclusion Criteria:-\n\n* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening\n* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\\>=) 24 weeks prior to screening according to european league against rheumatism\u002Famerican college of rheumatology (EULAR\u002FACR) classification criteria\n* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \\>= 6 and a clinical SLEDAI-2K \\>= 4 at screening, AND a clinical SLEDAI-2K score \\>= 4 points at Week 0, excluding points attributed to \"lupus headache,\" \"alopecia,\" and \"organic brain syndrome\"\n* Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization\n* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening\n\nExclusion Criteria:\n\n* History of severe, progressive and\u002For uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and\u002For any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory\n* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications\n* Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins\n* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation","ALL","18 Years","75 Years",{"count":1557,"type":1558},600,"ESTIMATED","INTERVENTIONAL",[1561],"PHASE3","The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).",[1564],"Lupus 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