A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

PHASE2CompletedINTERVENTIONAL
Enrollment

341

Participants

Timeline

Start Date

July 25, 2019

Primary Completion Date

January 19, 2022

Study Completion Date

July 14, 2022

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

Elsubrutinib

Capsule; Oral

DRUG

Placebo for elsubrutinib

Capsule; Oral

DRUG

Upadacitinib

Film-coated tablet; Oral

DRUG

Placebo for upadacitinib

Film-coated tablet; Oral

Trial Locations (160)

100

National Taiwan University Hospital /ID# 211752, Taipei

333

Linkou Chang Gung Memorial Hospital /ID# 211751, Taoyuan

1023

Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827, Budapest

1046

Aprillus Asistencia e Investigacion /ID# 211630, Ciudad Autonoma de Buenos Aire

1426

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685, Ciudad Autonoma Buenos Aires

1431

UMHAT Sveti Ivan Rilski /ID# 223139, Sofia

UMHAT Sveti Ivan Rilski /ID# 223140, Sofia

1878

CER Instituto Medico /ID# 222757, Quilmes

1900

Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679, La Plata

2000

Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634, Rosario

Instituto CAICI S.R.L /ID# 211633, Rosario

2019

Emeritus Research Sydney /ID# 222983, Botany

2025

Middlemore Clinical Trials /ID# 213504, Papatoetoe

2065

Royal North Shore Hospital /ID# 222982, St Leonards

3065

St Vincent's Hospital Melbourne /ID# 212311, Fitzroy Melbourne

3124

Emeritus Research /ID# 211903, Camberwell

3168

Monash Medical Centre /ID# 212313, Clayton

3240

Waikato Hospital /ID# 213505, Hamilton

4000

Centro de Investigaciones Medicas Tucuman /ID# 212714, San Miguel de Tucumán

Investigaciones Clinicas Tucuman /ID# 211942, San Miguel de Tucumán

4001

UMHAT Kaspela EOOD /ID# 223141, Plovdiv

4029

Royal Brisbane and Women's Hospital /ID# 212667, Herston

4032

Debreceni Egyetem Klinikai Kozpont /ID# 212042, Debrecen

4222

Griffith University /ID# 223543, Southport

4558

Rheumatology Research Unit Sunshine Coast /ID# 211902, Maroochydore

5000

Hospital Cordoba /ID# 212200, Córdoba

5011

The Queen Elizabeth Hospital /ID# 211901, Woodville South

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971, Gyula

8200

Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796, Veszprém

10117

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988, Berlin

11031

Taipei Medical University Hospital /ID# 221600, Taipei

11201

NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548, Brooklyn

11217

Taipei Veterans General Hosp /ID# 212216, Taipei

11850

CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875, Mexico City

15006

Hospital Universitario A Coruna - CHUAC /ID# 211719, A Coruña

15224

Allegheny Health Network Research Institute /ID# 211607, Pittsburgh

16499

Ajou University Hospital /ID# 211692, Suwon

20010

Medstar Health Research Institute /ID# 213335, Washington D.C.

20122

ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063, Milan

20902

The Center for Rheumatology and Bone Research /ID# 211610, Wheaton

22332

Inha University Hospital /ID# 211691, Incheon

24016

Carilion Clinic /ID# 213500, Roanoke

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674, Kiel

25801

Rheumatology and Pulmonary Clinic /ID# 211398, Beckley

28041

Hospital Universitario 12 de Octubre /ID# 211757, Madrid

32174

Millennium Research /ID# 219099, Ormond Beach

33000

CHU Bordeaux - Hopital Pellegrin /ID# 211832, Bordeaux

33100

Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858, Udine

33126

LeJenue Research Associates /ID# 212327, Miami

33173

Ctr Arthritis & Rheumatic Dise /ID# 212326, Miami

33180

Arthritis & Rheumatic Disease Specialties /ID# 214052, Aventura

33321

West Broward Rheumatology Associates /ID# 211881, Tamarac

33324

IRIS Research and Development, LLC /ID# 213053, Plantation

37000

Morales Vargas Centro de Investigacion S.C. /ID# 212946, León

38103

Univ TN Health Sciences Ctr /ID# 212177, Memphis

38119

Dr. Ramesh Gupta /ID# 213381, Memphis

40225

Universitaetsklinikum Duesseldorf /ID# 212408, Düsseldorf

40447

China Medical University Hospital /ID# 212179, Taichung

40705

Taichung Veterans General Hospital /ID# 211957, Taichung

41014

Hospital Universitario Virgen de Valme /ID# 212721, Seville

44124

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861, Cona

44160

Centro Integral en Reumatologia S.A de C.V /ID# 211876, Guadalajara

44690

Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532, Guadalajara

46026

Hospital Universitario y Politecnico La Fe /ID# 211720, Valencia

48013

Hospital Universitario Basurto /ID# 212722, Bilbao

48202

Henry Ford Health System /ID# 211676, Detroit

48910

June DO, PC /ID# 211674, Lansing

48960

Hospital Universitario de Galdakao /ID# 212803, Galdakao

52242

University of Iowa Hospitals and Clinics /ID# 215246, Iowa City

59037

CHRU Lille - Hopital Claude Huriez /ID# 211829, Lille

60061

Deerbrook Medical Associates /ID# 212251, Vernon Hills

61469

Chonnam National University Hospital /ID# 211695, Gwangju

67091

CHU Strasbourg - Hopital Civil /ID# 211981, Strasbourg

75007

Trinity Universal Research Associates - Carrollton /ID# 211527, Carrollton

75013

Hopital Pitie Salpetriere /ID# 211831, Paris

75150

SW Rheumatology Res. LLC /ID# 211520, Mesquite

77084

Accurate Clinical Management /ID# 213571, Houston

78213

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737, San Luis Potosí City

78745

Tekton Research, Inc. /ID# 211521, Austin

Tekton Research, Inc. /ID# 214182, Austin

79424

West Texas Clinical Research /ID# 211529, Lubbock

80002

Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894, Barranquilla

80045

University of Colorado Hospital /ID# 211314, Aurora

90211

Wallace Rheumatic Studies Center, LLC /ID# 211600, Beverly Hills

90502

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402, Torrance

91786

Inland Rheum Clin Trials Inc. /ID# 213617, Upland

94270

AP-HP - Hôpital Bicêtre /ID# 211968, Le Kremlin-Bicêtre

94578

East Bay Rheumatology Medical /ID# 211638, San Leandro

97070

Medical Care & Research SA de CV /ID# 212682, Mérida

98101

Virginia Mason Medical Center /ID# 211457, Seattle

100730

Peking Union Medical College Hospital /ID# 211614, Beijing

110221

Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895, Bogota

200040

Huashan Hospital, Fudan University /ID# 213976, Shanghai

200433

Shanghai Changhai Hospital /ID# 211819, Shanghai

210029

Jiangsu Province Hospital /ID# 211818, Nanjing

230001

Anhui Provincial Hospital /ID# 211812, Hefei

250001

Preventive Care Sas /Id# 211896, Chía

250252

Healthy Medical Center SAS /ID# 211899, Zipaquirá

410008

Xiangya Hospital Central South University /ID# 212919, Changsha

510080

Guangdong Provincial People's Hospital /ID# 211811, Guangzhou

830001

People's Hospital of Xinjiang /ID# 211821, Ürümqi

9808574

Tohoku University Hospital /ID# 213693, Sendai

85210-6871

Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522, Mesa

85032-9306

AZ Arthritis and Rheumotology Research, PLLC /ID# 211329, Phoenix

AZ Arthritis and Rheumotology Research, PLLC /ID# 214267, Phoenix

72401-6251

Arthritis and Rheumatism Associates /ID# 211411, Jonesboro

90623-1728

Arthritis & Osteo Medical Ctr /ID# 228235, La Palma

90720-5402

Valerius Medical Group & Research Center /ID# 211599, Los Alamitos

91042-2706

Medvin Clinical Research /ID# 211996, Tujunga

06510

Yale University /ID# 212824, New Haven

33614-7101

BayCare Medical Group, Inc. /ID# 218818, Tampa

60523-1245

Affinity Clinical Research /ID# 211496, Oak Brook

47714-0805

Qualmedica Research, LLC /ID# 214765, Evansville

02215-5400

Beth Israel Deaconess Medical Center /ID# 212321, Boston

63131-1703

West County Rheumatology /ID# 225051, St Louis

10016-2772

NYU Langone Orthopedic Center /ID# 213620, New York

43210-1229

Ohio State University - Wexner Medical Center /ID# 211636, Columbus

45377-9464

STAT Research, Inc. /ID# 211404, Vandalia

74136-2117

Premier Rheumatology of Oklahoma /ID# 213850, Tulsa

L8S 4K1

Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662, Hamilton

N6A 4V2

St. Josephs Health Care Centre /ID# 212331, London

M5T 2S8

Toronto Western Hospital /ID# 213336, Toronto

J1L 0H8

Diex Recherche Sherbrooke Inc. /ID# 217734, Sherbrooke

050034

Clinica Universitaria Bolivari /ID# 211897, Medellín

01307

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770, Dresden

00161

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195, Rome

457-8510

Chukyo Hospital /ID# 222625, Nagoya

460-0001

NHO Nagoya Medical Center /ID# 213974, Nagoya

810-8539

Hamanomachi Hospital /ID# 213696, Fukuoka

807-8556

Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548, Kitakyushu-shi

960-1295

Fukushima Medical University Hospital /ID# 213913, Fukushima

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694, Hiroshima

070-8644

National Hospital Organization Asahikawa Medical Center /ID# 213846, Asahikawa-shi

053-0034

Tomakomai City Hospital /ID# 214234, Tomakomai-shi

675-1327

Kita-harima Medical Center /ID# 215474, Ono-shi

890-0063

EIRAKU Internal Medicine Clinic /ID# 215419, Kagoshima

222-0036

Yokohama Rosai Hospital /ID# 213690, Yokohama

862-8655

Kumamoto Shinto General Hospital /ID# 215347, Kumamoto

390-8621

Shinshu University Hospital /ID# 213853, Matsumoto-shi

380-8582

Nagano Red Cross Hospital /ID# 214572, Nagano

350-8550

Saitama Medical Center /ID# 213687, Kawagoe-shi

160-8582

Keio University Hospital /ID# 216347, Shinjuku-ku

03100

RM Pharma Specialists S.A de C.V. /ID# 211879, Mexico City

1081 HV

Vrije Universiteit Medisch Centrum /ID# 214424, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum /ID# 214413, Leiden

3584 CX

Universitair Medisch Centrum Utrecht /ID# 214415, Utrecht

0622

North Shore Hospital /ID# 213506, Takapuna

61-545

Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483, Poznan

31-011

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146, Krakow

51-685

WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482, Wroclaw

01-868

Centrum Medyczne Pratia Warszawa /ID# 218176, Warsaw

00917-3104

GCM Medical Group PSC /ID# 211251, San Juan

00918-3756

Mindful Medical Research /ID# 213384, San Juan

05030

KonKuk University Medical Center /ID# 213410, Seoul

03080

Seoul National University Hospital /ID# 211740, Seoul

01009

HUA - Txagorritxu /ID# 212520, Vitoria-Gasteiz

08208

Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145, Sabadell

SE1 9RT

Guys and St Thomas NHS Foundation Trust /ID# 211931, London

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust /ID# 213189, Cambridge

M13 9WL

Manchester University NHS Foundation Trust /ID# 211838, Manchester

Sponsors

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INDUSTRY