Study Description
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE). A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)
Interventions
Ianalumab
Placebo
Eligibility Criteria
Inclusion Criteria:
* Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
* Diagnosis of systemic lupus erythematosus meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening.
* Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern.
* Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
* SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome"
* BILAG-2004 disease activity level at screening of at least 1 of the following:
* BILAG-2004 level 'A' disease in ≥ 1 organ system, Or
* BILAG-2004 level 'B' disease in ≥ 2 organ systems
* Weigh at least 35 kg at screening
Exclusion Criteria:
* Prior treatment with ianalumab
* History of receiving following treatment: I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening. II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower). IV) Traditional Chinese medicines administered within 30 days prior to randomization.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection
* Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Evidence of active tuberculosis infection
* History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening
* Any one of the following abnormal laboratory values prior to randomization
* Platelets \< 25000/mm\^3 (\< 25 x 10\^3/μL)
* Hemoglobin (Hgb) \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
* Absolute neutrophil count (ANC) (\< 0.8 x 10\^3/ μL)
* Severe organ dysfunction or life-threatening disease at screening
* Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment at screening
* Receipt of live/attenuated vaccine within a 4-week period before first dosing
* Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
* Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS
* History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug.
* Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
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Salvador,BA,40150 150,Brazil
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Sao Paulo,SP,01244-030,Brazil
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Vitoria,ES,29055 450,Brazil
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Sao Paulo,SP,04038-002,Brazil
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Belo Horizonte,MG,30150-221,Brazil
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Salvador,40301-155,Brazil
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Curitiba,PR,80030-110,Brazil
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Niteroi,RJ,24020 096,Brazil
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Rio de Janeiro,RJ,22211 230,Brazil
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Barretos,Sao Paulo,14784 400,Brazil
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Plovdiv,4002,Bulgaria
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Ruse,7002,Bulgaria
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Sofia,1680,Bulgaria
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Vancouver,British Columbia,V5z 1l7,Canada
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Hamilton,Ontario,L8n 3z5,Canada
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Toronto,Ontario,M5t 2s8,Canada
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Rimouski,Quebec,G5l 5t1,Canada
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Shantou,Guangdong,515041,China
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Xinxiang,453099,China
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Urumqi,Xinjiang,830001,China
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Pingxiang,Jiangxi,337000,China
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Haikou,Hainan,570311,China
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Beijing,100069,China
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Chang Chun,Jilin,130021,China
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Zhuzhou,Hunan,412000,China
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Beijing,100730,China
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Linyi,Shandong,276000,China
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Baotou,Inner Mongolia,014010,China
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Shanghai,200040,China
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Chengdu,Sichuan,610041,China
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Nanjing,Jiangsu,210008,China
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Guangzhou,Guangdong,510000,China
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Shanghai,200127,China
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Suzhou,Jiangsu,215004,China
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Guangzhou,Guangdong,510080,China
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Zhejiang,315016,China
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Nanchang,Jiangxi,330006,China
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Brno,63800,Czechia
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Praha 2,128 50,Czechia
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Uherske Hradiste,686 01,Czechia
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Guatemala,01010,Guatemala
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Guatemala City,01011,Guatemala
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Gyula,5700,Hungary
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Szekesfehervar,Fejer,8000,Hungary
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Haifa,3109601,Israel
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Ramat Gan,52621,Israel
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Miyazaki,889-1692,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Fuchu-city,Tokyo,183-8561,Japan
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Suita,Osaka,565 0871,Japan
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Osaka,545-8586,Japan
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Sapporo city,Hokkaido,060 8648,Japan
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Kitakyushu,Fukuoka,807-8556,Japan
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Fuchu,Tokyo,183-8524,Japan
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Iruma-gun,Saitama,350-0495,Japan
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Ono,Hyogo,675-1327,Japan
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Sendai city,Miyagi,983 8512,Japan
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Meguro,Tokyo,153-8515,Japan
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Bunkyo ku,Tokyo,113 8655,Japan
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Kawasaki,Kanagawa,216-8511,Japan
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Shinjuku-ku,Tokyo,160 8582,Japan
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Chiba,2608677,Japan
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Nagoya,Aichi,457 8510,Japan
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Bunkyo ku,Tokyo,113-8431,Japan
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Yokohama-city,Kanagawa,236-0004,Japan
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Fukuoka,815-8555,Japan
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Nagoya,Aichi,457-8511,Japan
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Bunkyo-ku,Tokyo,113-8519,Japan
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Yokohama,Kanagawa,222-0036,Japan
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Gifu,500-8717,Japan
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Ichikawa,Chiba,272 8516,Japan
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Chuo ku,Tokyo,104 8560,Japan
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Kurashiki,Okayama,710-8522,Japan
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Rzeszow,35 301,Poland
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Warszawa,00-874,Poland
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Wroclaw,Dolnoslaskie,52-210,Poland
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Warszawa,04141,Poland
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Bydgoszcz,85 168,Poland
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Bydgoszcz,85-065,Poland
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Bytom,41 902,Poland
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Lodz,90-338,Poland
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Lisboa,1349-019,Portugal
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Lisboa,1649 035,Portugal
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Braga,4710243,Portugal
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Leiria,2410-104,Portugal
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Lisboa,1050-034,Portugal
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Singapore,119074,Singapore
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Singapore,169608,Singapore
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Singapore,S308433,Singapore
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Bratislava,85101,Slovakia
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Kosice,04011,Slovakia
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Piestany,92101,Slovakia
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Bratislava,81109,Slovakia
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Stellenbosch,7600,South Africa
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Umhlanga,4320,South Africa
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Cape Town,7405,South Africa
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Panorama,7500,South Africa
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Pretoria,0002,South Africa
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Vitoria Gasteiz,Pais Vasco,01009,Spain
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Barcelona,Catalunya,08035,Spain
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Vigo,Pontevedra,36200,Spain
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Valencia,Comunidad Valenciana,46014,Spain
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Elche,Alicante,03203,Spain
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La Laguna,Santa Cruz De Tenerife,38320,Spain
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Badajoz,Extremadura,06080,Spain
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Santander,Cantabria,39008,Spain
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Madrid,28034,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Valladolid,Castilla Y Leon,47012,Spain
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San Sebastian de los Reyes,Madrid,28702,Spain
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Badalona,Catalunya,08916,Spain
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Pamplona,Navarra,31008,Spain
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Barcelona,Catalunya,08003,Spain
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Chiang Mai,50200,Thailand
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Songkhla,Hat Yai,90110,Thailand
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Ankara,06500,Turkey
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Aydin,09100,Turkey
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Etlik Ankara,06018,Turkey
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Izmir,35620,Turkey
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Konya,42080,Turkey
Yale University School Of Medicine
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New Haven,Connecticut,06520,United States
Fotios Koumpouras
Lake Cumberland Rheumatology and In
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New Albany,Indiana,47150,United States
Scott Lewis
Kara Lay
University Of Miami
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Miami,Florida,33136,United States
Maria Fernanda Carpintero
University of California San Diego
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La Jolla,California,92093,United States
Chelsey J F Smith
Prisma Health
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Columbia,South Carolina,29203,United States
Laketa Hillman-Daughety
Sunita Paudyal
NYU Langone Health
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Brooklyn,New York,11201,United States
Noemi Peralta
David Goddard
Millennium Clinical Trials
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Westlake Village,California,91361,United States
Elvira Lindwall
Ochsner Clinic Foundation
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Baton Rouge,Louisiana,70836,United States
Saravanan Thiagarajan
Univ of Nevada School of Med
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Las Vegas,Nevada,89102,United States
Walter Winn Chatham
Parris and Associates Rheumatology
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Lawrenceville,Georgia,30044,United States
Glenn Parris
Medical Center Main Campus
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Cleveland,Ohio,44109,United States
Nora Singer
Clinical Res Of W Florida
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Clearwater,Florida,33765,United States
Robert Levin
Keck School of Medicine
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Los Angeles,California,90033,United States
William Stohl
Clinical Research of West Florida Inc
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Tampa,Florida,33603,United States
Shanmugapriya Reddy
Henry Ford Health
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Detroit,Michigan,48202,United States
Alireza Meysami
STAT Research Inc
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Dayton,Ohio,45402,United States
Sanford Wolfe
Robert A Hozman MD SC
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Skokie,Illinois,60076,United States
Robert Hozman
Accurate Clinical Research Research
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Baytown,Texas,77521,United States
Sabeen Najam
GNP Research
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Hollywood,Florida,33024,United States
Mark Jaffe
Sahni Rheumatology and Therapy
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West Long Branch,New Jersey,07764,United States
Kiren Sahni
University of Colorado
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Aurora,Colorado,80045,United States
Christopher Striebich
Katherine Deluca
Epic Medical Research
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Red Oak,Texas,75154,United States
Sunny Patel
Shelby Research LLC
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Memphis,Tennessee,38119,United States
Nandini Thotakura
Ramesh C Gupta
Paramount Med Rsrch and Consult LLC
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Middleburg Heights,Ohio,44130,United States
Isam Diab
Providence Medical Center
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Burbank,California,91505,United States
Sue Chung
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