The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 vs.#46;placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03978520 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus (SLE) |
Study Website: | View Trial Website |
Experimental: Group 1: Upadacitinib and Elsubrutinib
Participants will be administered with elsubrutinib dose A and upadacitinib dose A.
Experimental: Group 2: Upadacitinib and Elsubrutinib
Participants will be administered with elsubrutinib dose A and upadacitinib dose B.
Experimental: Group 3: Elsubrutinib and Placebo for Updadacitinib
Participants will be administered with elsubrutinib dose A and placebo for upadacitinib.
Experimental: Group 4: Upadacitinib and Placebo for Elsubrutinib
Participants will be administered with placebo for elsubrutinib and upadacitinib dose A.
Experimental: Group 5: Placebo for Elsubrutinib and Placebo for Upadacitinib
Participants will be administered with placebo for elsubrutinib and placebo for upadacitinib.
Drug: - Elsubrutinib
Capsule; Oral
Drug: - Placebo for Elsubrutinib
Capsule; Oral
Drug: - Upadacitinib
Tablet; Oral
Drug: - Placebo for upadacitinib
Tablet; Oral
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
Mesa, Arizona, 85210-6871
Status
Recruiting
Address
Arizona Arthritis & Rheumatolo /ID# 211329
Phoenix, Arizona, 85032-9306
Status
Recruiting
Address
AZ Arthritis & Rheuma Research /ID# 214267
Phoenix, Arizona, 85032
Status
Recruiting
Address
Arthritis and Rheumatism Associates /ID# 211411
Jonesboro, Arkansas, 72401
Status
Recruiting
Address
Attune Health /ID# 211600
Beverly Hills, California, 90211
Status
Recruiting
Address
Arthritis & Osteo Medical Ctr /ID# 228235
La Palma, California, 90623-1728
Status
Recruiting
Address
Valerius Medical Group /ID# 211599
Los Alamitos, California, 90720
Status
Recruiting
Address
East Bay Rheumatology Medical /ID# 211638
San Leandro, California, 94578
Status
Recruiting
Address
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
Torrance, California, 90502
Status
Recruiting
Address
Medvin Clinical Research /ID# 211996
Tujunga, California, 91042-2706
Status
Recruiting
Address
Inland Rheum Clin Trials Inc. /ID# 213617
Upland, California, 91786
Status
Recruiting
Address
University of Colorado Hospita /ID# 211314
Denver, Colorado, 80045
Status
Recruiting
Address
Yale University /ID# 212824
New Haven, Connecticut, 06510
Status
Completed
Address
Medstar Health Research Institute /ID# 213335
Washington, District of Columbia, 20010
Status
Recruiting
Address
Arthritis & Rheumatic Disease Specialties /ID# 214052
Aventura, Florida, 33180
Status
Completed
Address
LeJenue Research Associates /ID# 212327
Miami, Florida, 33126
Status
Completed
Address
Ctr Arthritis & Rheumatic Dise /ID# 212326
Miami, Florida, 33173
Status
Recruiting
Address
Millennium Research /ID# 219099
Ormond Beach, Florida, 32174
Status
Recruiting
Address
IRIS Research and Development, LLC /ID# 213053
Plantation, Florida, 33324
Status
Recruiting
Address
West Broward Rheumatology Associates /ID# 211881
Tamarac, Florida, 33321
Status
Recruiting
Address
BayCare Medical Group, Inc. /ID# 218818
Tampa, Florida, 33614-7101
Status
Recruiting
Address
Affinity Clinical Research Institute /ID# 211496
Oak Brook, Illinois, 60523-1245
Status
Recruiting
Address
Deerbrook Medical Associates /ID# 212251
Vernon Hills, Illinois, 60061
Status
Recruiting
Address
Rheumatology, Arthritis & Immunology Clinic /ID# 214765
Evansville, Indiana, 47714-0805
Status
Recruiting
Address
University of Iowa Hospitals and Clinics /ID# 215246
Iowa City, Iowa, 52242
Status
Recruiting
Address
The Center for Rheumatology and Bone Research /ID# 211610
Wheaton, Maryland, 20902
Status
Recruiting
Address
Beth Israel Deaconess Medical Center /ID# 212321
Boston, Massachusetts, 02215-5400
Status
Recruiting
Address
Henry Ford Health System /ID# 211676
Detroit, Michigan, 48202
Status
Recruiting
Address
June DO, PC /ID# 211674
Lansing, Michigan, 48910
Status
Recruiting
Address
West County Rheumatology /ID# 225051
Saint Louis, Missouri, 63131-1703
Status
Recruiting
Address
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
Brooklyn, New York, 11201
Status
Recruiting
Address
NYU Langone Orthopedic Center /ID# 213620
New York, New York, 10016-2772
Status
Recruiting
Address
Ohio State University - Wexner Medical Center /ID# 211636
Columbus, Ohio, 43210-1229
Status
Recruiting
Address
STAT Research, Inc. /ID# 211404
Vandalia, Ohio, 45377-9464
Status
Recruiting
Address
Premier Rheumatology of Oklahoma /ID# 213850
Tulsa, Oklahoma, 74136-2117
Status
Recruiting
Address
Allegheny Health Network /ID# 211607
Pittsburgh, Pennsylvania, 15212-4769
Status
Recruiting
Address
Univ TN Health Sciences Ctr /ID# 212177
Memphis, Tennessee, 38103
Status
Recruiting
Address
Dr. Ramesh Gupta /ID# 213381
Memphis, Tennessee, 38119
Status
Recruiting
Address
Tekton Research, Inc. /ID# 211521
Austin, Texas, 78745
Status
Completed
Address
Tekton Research, Inc. /ID# 214182
Austin, Texas, 78745
Status
Recruiting
Address
Trinity Universal Research Associates - Carrollton /ID# 211527
Carrollton, Texas, 75007
Status
Recruiting
Address
Accurate Clinical Management /ID# 213571
Houston, Texas, 77004
Status
Recruiting
Address
West Texas Clinical Research /ID# 211529
Lubbock, Texas, 79410-1198
Status
Recruiting
Address
SW Rheumatology Res. LLC /ID# 211520
Mesquite, Texas, 75150
Status
Recruiting
Address
Carilion Clinic /ID# 213500
Roanoke, Virginia, 24016
Status
Recruiting
Address
Virginia Mason - Seattle Orthapedics /ID# 211457
Seattle, Washington, 98101
Status
Recruiting
Address
Rheumatology and Pulmonary Clinic /ID# 211398
Beckley, West Virginia, 25801
Status
Recruiting
Address
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
La Plata, Buenos Aires, 1906
Status
Recruiting
Address
CER Instituto Medico /ID# 222757
Quilmes, Buenos Aires, 1878
Status
Recruiting
Address
Aprillus Asistencia e Investigacion /ID# 211630
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, 1046
Status
Not yet recruiting
Address
Consultorio Medico Dra. Rivera /ID# 221885
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, 1426
Status
Recruiting
Address
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, 1426
Status
Recruiting
Address
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Instituto CAICI /ID# 211633
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Centro Medico Privado de Reumatologia /ID# 212714
San Miguel de Tucuman, Tucuman, 4000
Status
Recruiting
Address
Instituto de Investigaciones Clinicas Tucuman /ID# 211942
San Miguel de Tucuman, Tucuman, 4000
Status
Recruiting
Address
Hospital Cordoba /ID# 212200
Cordoba, , 5000
Status
Recruiting
Address
Emeritus Research Sydney /ID# 222983
Botany, New South Wales, 2019
Status
Recruiting
Address
Royal North Shore Hospital /ID# 222982
St Leonards, New South Wales, 2065
Status
Recruiting
Address
Royal Brisbane and Women's Hospital /ID# 212667
Herston, Queensland, 4029
Status
Recruiting
Address
Rheumatology Research Unit Sunshine Coast /ID# 211902
Maroochydore, Queensland, 4558
Status
Recruiting
Address
Griffith University /ID# 223543
Southport, Queensland, 4222
Status
Recruiting
Address
The Queen Elizabeth Hospital /ID# 211901
Woodville, South Australia, 5011
Status
Recruiting
Address
Emeritus Research /ID# 211903
Camberwell, Victoria, 3124
Status
Recruiting
Address
Monash Medical Centre /ID# 212313
Clayton, Victoria, 3168
Status
Recruiting
Address
St Vincent's Hospital Melbourne /ID# 212311
Fitzroy, Victoria, 3065
Status
Recruiting
Address
MHAT Kaspela /ID# 223141
Plovdiv, , 4001
Status
Recruiting
Address
UMHAT Sveti Ivan Rilski /ID# 223139
Sofia, , 1612
Status
Recruiting
Address
UMHAT Sveti Ivan Rilski /ID# 223140
Sofia, , 1612
Status
Recruiting
Address
McMaster University Med Cent /ID# 212662
Hamilton, Ontario, L8S 4K1
Status
Recruiting
Address
St. Josephs Health Care Centre /ID# 212331
London, Ontario, N6A 4V2
Status
Recruiting
Address
Toronto Western Hospital /ID# 213336
Toronto, Ontario, M5T 2S8
Status
Recruiting
Address
Diex Recherche Sherbrooke Inc. /ID# 217734
Sherbrooke, Quebec, J1L 0H8
Status
Recruiting
Address
Anhui Provincial Hospital /ID# 211812
Hefei, Anhui, 230001
Status
Recruiting
Address
Guangdong Provincial People's Hospital /ID# 211811
Guangzhou, Guangdong, 510080
Status
Recruiting
Address
Xiangya Hospital Central South University /ID# 212919
Changsha, Hunan, 410008
Status
Recruiting
Address
Jiangsu Province Hospital /ID# 211818
Nanjing, Jiangsu, 210029
Status
Recruiting
Address
Shanghai Changhai Hospital /ID# 211819
Shanghai, Shanghai, 200433
Status
Recruiting
Address
Peking Union Med College Hosp /ID# 211614
Beijing, , 100730
Status
Recruiting
Address
Huashan Hospital of Fudan University /ID# 213976
Shanghai, , 200040
Status
Recruiting
Address
Xinjiang Uiger Municipal People's Hospital /ID# 211821
Urumqi, , 830001
Status
Recruiting
Address
Ctr Int de Reum del Caribe SAS /ID# 211894
Barranquilla, Atlantico, 80002
Status
Recruiting
Address
Centro de Investigacion en Reumatologia CIREEM /ID# 211895
Bogota, Cundinamarca, 110231
Status
Recruiting
Address
Preventive Care Sas /Id# 211896
Chia, Cundinamarca, 250001
Status
Recruiting
Address
Healthy Medical Center SAS /ID# 211899
Zipaquira, Cundinamarca, 250252
Status
Recruiting
Address
Clinica Universitaria Bolivari /ID# 211897
Medellin, , 050034
Status
Recruiting
Address
CHRU Lille - Hopital Claude Huriez /ID# 211829
Lille CEDEX, Hauts-de-France, 59045
Status
Recruiting
Address
CHU Bordeaux-Hopital Pellegrin /ID# 211832
Bordeaux, , 33076
Status
Recruiting
Address
CHU Bicetre /ID# 211968
Le Kremlin Bicetre, , 94270
Status
Recruiting
Address
CHU Paris-GH La Pitie Salpetriere /ID# 211831
Paris, , 75013
Status
Recruiting
Address
Hôpital Civil /ID# 211981
Strasbourg CEDEX, , 67091
Status
Recruiting
Address
Universitaetsklinikum Duesseldorf /ID# 212408
Dusseldorf, Nordrhein-Westfalen, 40225
Status
Recruiting
Address
Charité - Med Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie /ID# 211988
Berlin, , 10117
Status
Recruiting
Address
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
Dresden, , 01307
Status
Recruiting
Address
Univ Hosp Schleswig-Holstein /ID# 212674
Kiel, , 24105
Status
Recruiting
Address
Orszagos Reumatologiai es Fizi /ID# 211827
Budapest, , 1023
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont /ID# 212042
Debrecen, , 4032
Status
Recruiting
Address
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
Gyula, , 5700
Status
Recruiting
Address
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
Veszprem, , 8200
Status
Not yet recruiting
Address
AOU Policlinico Umberto I /ID# 212195
Rome, Lazio, 00185
Status
Recruiting
Address
AOU Arcispedale Sant Anna di /ID# 211861
Cona, , 44124
Status
Not yet recruiting
Address
Azienda Istituto Gaetano Pini /ID# 215063
Milan, , 20122
Status
Recruiting
Address
Azienda Sanitaria Universitaria Friuli Centrale /ID# 211858
Udine, , 33100
Status
Recruiting
Address
Chukyo Hospital /ID# 222625
Nagoya-shi, Aichi, 457-8510
Status
Recruiting
Address
NHO Nagoya Medical Center /ID# 213974
Nagoya-shi, Aichi, 460-0001
Status
Recruiting
Address
Hamanomachi Hospital /ID# 213696
Fukuoka-shi, Fukuoka, 810-8539
Status
Recruiting
Address
Hospital of the University of Occupational and Environmental Health /ID# 217548
Kitakyushu-shi, Fukuoka, 807-8556
Status
Recruiting
Address
Fukushima Medical University Hospital /ID# 213913
Fukushima-shi, Fukushima, 960-1295
Status
Recruiting
Address
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 213694
Hiroshima-shi, Hiroshima, 730-8619
Status
Recruiting
Address
National Hospital Organization Asahikawa Medical Center /ID# 213846
Asahikawa-shi, Hokkaido, 070-8644
Status
Recruiting
Address
Tomakomai City Hospital /ID# 214234
Tomakomai-shi, Hokkaido, 053-0034
Status
Recruiting
Address
Kita-harima Medical Center /ID# 215474
Ono-shi, Hyogo, 675-1327
Status
Recruiting
Address
Eiraku Internal Medicine Clinic /ID# 215419
Kagoshima-shi, Kagoshima, 890-0063
Status
Recruiting
Address
Yokohama Rosai Hospital /ID# 213690
Yokohama-shi, Kanagawa, 222-0036
Status
Recruiting
Address
Kumamoto Shinto General Hospital /ID# 215347
Kumamoto-shi, Kumamoto, 8628655
Status
Recruiting
Address
Tohoku University Hospital /ID# 213693
Sendai-shi, Miyagi, 9808574
Status
Recruiting
Address
Shinshu University Hospital /ID# 213853
Matsumoto-shi, Nagano, 390-8621
Status
Recruiting
Address
Nagano Red Cross Hospital /ID# 214572
Nagano-shi, Nagano, 380-8582
Status
Recruiting
Address
Saitama Medical Center /ID# 213687
Kawagoe-shi, Saitama, 350-8550
Status
Recruiting
Address
Keio University Hospital /ID# 216347
Shinjuku-ku, Tokyo, 160-8582
Status
Recruiting
Address
Ajou University Hospital /ID# 211692
Suwon, Gyeonggido, 16499
Status
Recruiting
Address
Konkuk University Medical Ctr /ID# 213410
Seoul, Seoul Teugbyeolsi, 05030
Status
Recruiting
Address
Chonnam National University Hospital /ID# 211695
Gwangju, , 61469
Status
Recruiting
Address
Inha University Hospital /ID# 211691
Incheon, , 22332
Status
Recruiting
Address
Seoul National University Hospital /ID# 211740
Seoul, , 03080
Status
Recruiting
Address
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
Mexico City, Ciudad De Mexico, 11850
Status
Recruiting
Address
Morales Vargas Centro de Investigacion S.C. /ID# 212946
Leon, Guanajuato, 37000
Status
Recruiting
Address
Centro Integral en Reumatologia S.A de C.V /ID# 211876
Guadalajara, Jalisco, 44160
Status
Recruiting
Address
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
Guadalajara, Jalisco, 44690
Status
Recruiting
Address
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
San Luis Potosí, San Luis Potosi, 78213
Status
Recruiting
Address
Medical Care & Research SA de CV /ID# 212682
Mérida, Yucatan, 97070
Status
Recruiting
Address
RM Pharma Specialists S.A de C.V /ID# 211879
Mexico City, , 03100
Status
Recruiting
Address
Vrije Universiteit Medisch Centrum /ID# 214424
Amsterdam, , 1081 HV
Status
Recruiting
Address
Leids Universitair Medisch Centrum /ID# 214413
Leiden, , 2333 ZA
Status
Recruiting
Address
Universitair Medisch Centrum Utrecht /ID# 214415
Utrecht, , 3584 CX
Status
Recruiting
Address
Waikato Hospital /ID# 213505
Hamilton, Waikato, 3204
Status
Recruiting
Address
North Shore Hospital /ID# 213506
Auckland, , 0622
Status
Completed
Address
Middlemore Clinical Trials /ID# 213504
Auckland, , 2025
Status
Recruiting
Address
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
Wroclaw, Dolnoslaskie, 51-685
Status
Recruiting
Address
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
Krakow, Malopolskie, 31-011
Status
Recruiting
Address
Centrum Medyczne Pratia Warszawa /ID# 218176
Warszawa, Mazowieckie, 01-868
Status
Recruiting
Address
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
Poznan, Wielkopolskie, 61-545
Status
Recruiting
Address
GCM Medical Group, PSC /ID# 211251
San Juan, , 00917
Status
Recruiting
Address
Mindful Medical Research /ID# 213384
San Juan, , 00918-3756
Status
Recruiting
Address
Hospital Universitario A Coruña - CHUAC /ID# 211719
A Coruña, A Coruna, 15006
Status
Recruiting
Address
HUA - Txagorritxu /ID# 212520
Vitoria, Alava, 01009
Status
Recruiting
Address
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
Sabadell, Barcelona, 08208
Status
Recruiting
Address
Hospital Universitario Basurto /ID# 212722
Bilbao, Vizcaya, 48013
Status
Recruiting
Address
Hospital Universitario de Galdakao /ID# 212803
Galdakao, Vizcaya, 48960
Status
Recruiting
Address
Hospital Universitario 12 de Octubre /ID# 211757
Madrid, , 28041
Status
Recruiting
Address
Hospital Universitario Virgen de Valme /ID# 212721
Sevilla, , 41014
Status
Recruiting
Address
Hospital Universitario y Politecnico La Fe /ID# 211720
Valencia, , 46026
Status
Recruiting
Address
China Medical University Hosp /ID# 212179
Taichung City, Taichung, 40447
Status
Recruiting
Address
National Taiwan University Hospital /ID# 211752
Taipei City, Taipei, 100
Status
Recruiting
Address
Taichung Veterans General Hosp /ID# 211957
Taichung City, , 40705
Status
Recruiting
Address
Taipei Medical University Hospital /ID# 221600
Taipei City, , 11031
Status
Recruiting
Address
Taipei Veterans General Hosp /ID# 212216
Taipei City, , 11217
Status
Recruiting
Address
Linkou Chang Gung Memorial Ho /ID# 211751
Taoyuan City, , 33305
Status
Not yet recruiting
Address
Addenbrookes Hospital /ID# 213189
Cambridge, , CB2 0SP
Status
Recruiting
Address
Guy's Hospital /ID# 211931
London, , SE1 9RT
Status
Recruiting
Address
Manchester Royal Infirmary /ID# 211838
Manchester, , M13 9WL