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)
NCT ID: NCT03978520
Last Updated: 2023-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
341 participants
INTERVENTIONAL
2019-07-25
2022-07-14
Brief Summary
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A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elsubrutinib placebo/upadacitinib placebo
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
Placebo for elsubrutinib
Capsule; Oral
Placebo for upadacitinib
Film-coated tablet; Oral
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Elsubrutinib placebo/upadacitinib 30 mg
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Placebo for elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Elsubrutinib 60 mg/upadacitinib placebo
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
Elsubrutinib
Capsule; Oral
Placebo for upadacitinib
Film-coated tablet; Oral
Interventions
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Elsubrutinib
Capsule; Oral
Placebo for elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Placebo for upadacitinib
Film-coated tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At Screening, must have at least one of the following:
* antinuclear antibody (ANA)+ (titer ≥ 1:80)
* anti-dsDNA+
* anti-Smith+
* SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening:
* If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
* If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
* Score must be re-confirmed at the Baseline visit.
* Physician's Global Assessment (PhGA) ≥ 1 during screening period.
* Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (\<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg).
* No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
Mesa, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
Phoenix, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
Phoenix, Arizona, United States
Arthritis and Rheumatism Associates /ID# 211411
Jonesboro, Arkansas, United States
Wallace Rheumatic Studies Center, LLC /ID# 211600
Beverly Hills, California, United States
Arthritis & Osteo Medical Ctr /ID# 228235
La Palma, California, United States
Valerius Medical Group & Research Center /ID# 211599
Los Alamitos, California, United States
East Bay Rheumatology Medical /ID# 211638
San Leandro, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
Torrance, California, United States
Medvin Clinical Research /ID# 211996
Tujunga, California, United States
Inland Rheum Clin Trials Inc. /ID# 213617
Upland, California, United States
University of Colorado Hospital /ID# 211314
Aurora, Colorado, United States
Yale University /ID# 212824
New Haven, Connecticut, United States
Medstar Health Research Institute /ID# 213335
Washington D.C., District of Columbia, United States
Arthritis & Rheumatic Disease Specialties /ID# 214052
Aventura, Florida, United States
LeJenue Research Associates /ID# 212327
Miami, Florida, United States
Ctr Arthritis & Rheumatic Dise /ID# 212326
Miami, Florida, United States
Millennium Research /ID# 219099
Ormond Beach, Florida, United States
IRIS Research and Development, LLC /ID# 213053
Plantation, Florida, United States
West Broward Rheumatology Associates /ID# 211881
Tamarac, Florida, United States
BayCare Medical Group, Inc. /ID# 218818
Tampa, Florida, United States
Affinity Clinical Research /ID# 211496
Oak Brook, Illinois, United States
Deerbrook Medical Associates /ID# 212251
Vernon Hills, Illinois, United States
Qualmedica Research, LLC /ID# 214765
Evansville, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 215246
Iowa City, Iowa, United States
The Center for Rheumatology and Bone Research /ID# 211610
Wheaton, Maryland, United States
Beth Israel Deaconess Medical Center /ID# 212321
Boston, Massachusetts, United States
Henry Ford Health System /ID# 211676
Detroit, Michigan, United States
June DO, PC /ID# 211674
Lansing, Michigan, United States
West County Rheumatology /ID# 225051
St Louis, Missouri, United States
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
Brooklyn, New York, United States
NYU Langone Orthopedic Center /ID# 213620
New York, New York, United States
Ohio State University - Wexner Medical Center /ID# 211636
Columbus, Ohio, United States
STAT Research, Inc. /ID# 211404
Vandalia, Ohio, United States
Premier Rheumatology of Oklahoma /ID# 213850
Tulsa, Oklahoma, United States
Allegheny Health Network Research Institute /ID# 211607
Pittsburgh, Pennsylvania, United States
Univ TN Health Sciences Ctr /ID# 212177
Memphis, Tennessee, United States
Dr. Ramesh Gupta /ID# 213381
Memphis, Tennessee, United States
Tekton Research, Inc. /ID# 211521
Austin, Texas, United States
Tekton Research, Inc. /ID# 214182
Austin, Texas, United States
Trinity Universal Research Associates - Carrollton /ID# 211527
Carrollton, Texas, United States
Accurate Clinical Management /ID# 213571
Houston, Texas, United States
West Texas Clinical Research /ID# 211529
Lubbock, Texas, United States
SW Rheumatology Res. LLC /ID# 211520
Mesquite, Texas, United States
Carilion Clinic /ID# 213500
Roanoke, Virginia, United States
Virginia Mason Medical Center /ID# 211457
Seattle, Washington, United States
Rheumatology and Pulmonary Clinic /ID# 211398
Beckley, West Virginia, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
La Plata, Buenos Aires, Argentina
CER Instituto Medico /ID# 222757
Quilmes, Buenos Aires, Argentina
Aprillus Asistencia e Investigacion /ID# 211630
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
Rosario, Santa Fe Province, Argentina
Instituto CAICI S.R.L /ID# 211633
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 212714
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman /ID# 211942
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Cordoba /ID# 212200
Córdoba, , Argentina
Emeritus Research Sydney /ID# 222983
Botany, New South Wales, Australia
Royal North Shore Hospital /ID# 222982
St Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 212667
Herston, Queensland, Australia
Rheumatology Research Unit Sunshine Coast /ID# 211902
Maroochydore, Queensland, Australia
Griffith University /ID# 223543
Southport, Queensland, Australia
The Queen Elizabeth Hospital /ID# 211901
Woodville South, South Australia, Australia
Emeritus Research /ID# 211903
Camberwell, Victoria, Australia
Monash Medical Centre /ID# 212313
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 212311
Fitzroy Melbourne, Victoria, Australia
UMHAT Kaspela EOOD /ID# 223141
Plovdiv, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223139
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223140
Sofia, , Bulgaria
Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
Hamilton, Ontario, Canada
St. Josephs Health Care Centre /ID# 212331
London, Ontario, Canada
Toronto Western Hospital /ID# 213336
Toronto, Ontario, Canada
Diex Recherche Sherbrooke Inc. /ID# 217734
Sherbrooke, Quebec, Canada
Anhui Provincial Hospital /ID# 211812
Hefei, Anhui, China
Peking Union Medical College Hospital /ID# 211614
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital /ID# 211811
Guangzhou, Guangdong, China
Xiangya Hospital Central South University /ID# 212919
Changsha, Hunan, China
Jiangsu Province Hospital /ID# 211818
Nanjing, Jiangsu, China
Huashan Hospital, Fudan University /ID# 213976
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital /ID# 211819
Shanghai, Shanghai Municipality, China
People's Hospital of Xinjiang /ID# 211821
Ürümqi, , China
Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
Barranquilla, Atlántico, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
Bogota, Cundinamarca, Colombia
Preventive Care Sas /Id# 211896
Chía, Cundinamarca, Colombia
Healthy Medical Center SAS /ID# 211899
Zipaquirá, Cundinamarca, Colombia
Clinica Universitaria Bolivari /ID# 211897
Medellín, , Colombia
CHRU Lille - Hopital Claude Huriez /ID# 211829
Lille, Hauts-de-France, France
CHU Bordeaux - Hopital Pellegrin /ID# 211832
Bordeaux, , France
AP-HP - Hôpital Bicêtre /ID# 211968
Le Kremlin-Bicêtre, , France
Hopital Pitie Salpetriere /ID# 211831
Paris, , France
CHU Strasbourg - Hopital Civil /ID# 211981
Strasbourg, , France
Universitaetsklinikum Duesseldorf /ID# 212408
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
Dresden, , Germany
Debreceni Egyetem Klinikai Kozpont /ID# 212042
Debrecen, Hajdú-Bihar, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
Veszprém, Veszprém megye, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
Gyula, , Hungary
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
Cona, Ferrara, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
Rome, Lazio, Italy
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
Milan, , Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
Udine, , Italy
Chukyo Hospital /ID# 222625
Nagoya, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 213974
Nagoya, Aichi-ken, Japan
Hamanomachi Hospital /ID# 213696
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
Kitakyushu-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 213913
Fukushima, Fukushima, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
Hiroshima, Hiroshima, Japan
National Hospital Organization Asahikawa Medical Center /ID# 213846
Asahikawa-shi, Hokkaido, Japan
Tomakomai City Hospital /ID# 214234
Tomakomai-shi, Hokkaido, Japan
Kita-harima Medical Center /ID# 215474
Ono-shi, Hyōgo, Japan
EIRAKU Internal Medicine Clinic /ID# 215419
Kagoshima, Kagoshima-ken, Japan
Yokohama Rosai Hospital /ID# 213690
Yokohama, Kanagawa, Japan
Kumamoto Shinto General Hospital /ID# 215347
Kumamoto, Kumamoto, Japan
Tohoku University Hospital /ID# 213693
Sendai, Miyagi, Japan
Shinshu University Hospital /ID# 213853
Matsumoto-shi, Nagano, Japan
Nagano Red Cross Hospital /ID# 214572
Nagano, Nagano, Japan
Saitama Medical Center /ID# 213687
Kawagoe-shi, Saitama, Japan
Keio University Hospital /ID# 216347
Shinjuku-ku, Tokyo, Japan
Morales Vargas Centro de Investigacion S.C. /ID# 212946
León, Guanajuato, Mexico
Centro Integral en Reumatologia S.A de C.V /ID# 211876
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
Guadalajara, Jalisco, Mexico
RM Pharma Specialists S.A de C.V. /ID# 211879
Mexico City, Mexico City, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
Mexico City, Mexico City, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
San Luis Potosí City, San Luis Potosí, Mexico
Medical Care & Research SA de CV /ID# 212682
Mérida, Yucatán, Mexico
Vrije Universiteit Medisch Centrum /ID# 214424
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum /ID# 214413
Leiden, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 214415
Utrecht, , Netherlands
Middlemore Clinical Trials /ID# 213504
Papatoetoe, Auckland, New Zealand
North Shore Hospital /ID# 213506
Takapuna, Auckland, New Zealand
Waikato Hospital /ID# 213505
Hamilton, Waikato Region, New Zealand
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
Poznan, Greater Poland Voivodeship, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
Krakow, Lesser Poland Voivodeship, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Pratia Warszawa /ID# 218176
Warsaw, Masovian Voivodeship, Poland
GCM Medical Group PSC /ID# 211251
San Juan, , Puerto Rico
Mindful Medical Research /ID# 213384
San Juan, , Puerto Rico
Ajou University Hospital /ID# 211692
Suwon, Gyeonggido, South Korea
KonKuk University Medical Center /ID# 213410
Seoul, Seoul Teugbyeolsi, South Korea
Chonnam National University Hospital /ID# 211695
Gwangju, , South Korea
Inha University Hospital /ID# 211691
Incheon, , South Korea
Seoul National University Hospital /ID# 211740
Seoul, , South Korea
HUA - Txagorritxu /ID# 212520
Vitoria-Gasteiz, Alava, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
Sabadell, Barcelona, Spain
Hospital Universitario Basurto /ID# 212722
Bilbao, Vizcaya, Spain
Hospital Universitario de Galdakao /ID# 212803
Galdakao, Vizcaya, Spain
Hospital Universitario A Coruna - CHUAC /ID# 211719
A Coruña, , Spain
Hospital Universitario 12 de Octubre /ID# 211757
Madrid, , Spain
Hospital Universitario Virgen de Valme /ID# 212721
Seville, , Spain
Hospital Universitario y Politecnico La Fe /ID# 211720
Valencia, , Spain
China Medical University Hospital /ID# 212179
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 211957
Taichung, , Taiwan
National Taiwan University Hospital /ID# 211752
Taipei, , Taiwan
Taipei Medical University Hospital /ID# 221600
Taipei, , Taiwan
Taipei Veterans General Hosp /ID# 212216
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 211751
Taoyuan, , Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 211931
London, London, City of, United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 213189
Cambridge, , United Kingdom
Manchester University NHS Foundation Trust /ID# 211838
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2019-000638-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-130
Identifier Type: -
Identifier Source: org_study_id
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