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) (SLEek)

A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs 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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Drug: Elsubrutinib; Drug: Placebo for elsubrutinib; Drug: Placebo for upadacitinib; Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5000
    • Hospital Cordoba /ID# 212200
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1426
      • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
    • La Plata, Buenos Aires, Argentina, 1900
      • Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
    • Quilmes, Buenos Aires, Argentina, 1878
      • CER Instituto Medico /ID# 222757
  • Ciuadad Autonoma De Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1046
      • Aprillus Asistencia e Investigacion /ID# 211630
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto CAICI S.R.L /ID# 211633
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Centro de Investigaciones Medicas Tucuman /ID# 212714
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Investigaciones Clinicas Tucuman /ID# 211942
• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research Sydney /ID# 222983
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital /ID# 222982
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital /ID# 212667
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit Sunshine Coast /ID# 211902
    • Southport, Queensland, Australia, 4222
      • Griffith University /ID# 223543
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 211901
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research /ID# 211903
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre /ID# 212313
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne /ID# 212311
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela EOOD /ID# 223141
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 223139
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 223140
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
    • London, Ontario, Canada, N6A 4V2
      • St. Josephs Health Care Centre /ID# 212331
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital /ID# 213336
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc. /ID# 217734
• China
  • Urumqi, China, 830001
    • People's Hospital of Xinjiang /ID# 211821
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital /ID# 211812
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital /ID# 211614
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 211811
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University /ID# 212919
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital /ID# 211818
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital, Fudan University /ID# 213976
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital /ID# 211819
• Colombia
  • Medellin, Colombia, 050034
    • Clinica Universitaria Bolivari /ID# 211897
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 80002
      • Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
    • Chia, Cundinamarca, Colombia, 250001
      • Preventive Care Sas /Id# 211896
    • Zipaquira, Cundinamarca, Colombia, 250252
      • Healthy Medical Center SAS /ID# 211899
• France
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hopital Pellegrin /ID# 211832
  • Le Kremlin Bicetre, France, 94270
    • AP-HP - Hôpital Bicêtre /ID# 211968
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 211831
  • Strasbourg cedex, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 211981
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 211829
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Universitaetsklinikum Duesseldorf /ID# 212408
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
• Hungary
  • Budapest, Hungary, 1023
    • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont /ID# 212042
  • Veszprem
    • Veszprém, Veszprem, Hungary, 8200
      • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
• Italy
  • Milan, Italy, 20122
    • ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
  • Udine, Italy, 33100
    • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
  • Lazio
    • Rome, Lazio, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 457-8510
      • Chukyo Hospital /ID# 222625
    • Nagoya-shi, Aichi, Japan, 460-0001
      • NHO Nagoya Medical Center /ID# 213974
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 810-8539
      • Hamanomachi Hospital /ID# 213696
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 213913
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center /ID# 213846
    • Tomakomai-shi, Hokkaido, Japan, 053-0034
      • Tomakomai City Hospital /ID# 214234
  • Hyogo
    • Ono-shi, Hyogo, Japan, 675-1327
      • Kita-harima Medical Center /ID# 215474
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-0063
      • EIRAKU Internal Medicine Clinic /ID# 215419
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 222-0036
      • Yokohama Rosai Hospital /ID# 213690
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 862-8655
      • Kumamoto Shinto General Hospital /ID# 215347
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 213693
  • Nagano
    • Matsumoto-shi, Nagano, Japan, 390-8621
      • Shinshu University Hospital /ID# 213853
    • Nagano-shi, Nagano, Japan, 380-8582
      • Nagano Red Cross Hospital /ID# 214572
  • Saitama
    • Kawagoe-shi, Saitama, Japan, 350-8550
      • Saitama Medical Center /ID# 213687
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 216347
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital /ID# 211695
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital /ID# 211691
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 211740
  • Gyeonggido
    • Suwon, Gyeonggido, Korea, Republic of, 16499
      • Ajou University Hospital /ID# 211692
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
      • KonKuk University Medical Center /ID# 213410
• Mexico
  • Ciudad De Mexico
    • Mexico City, Ciudad De Mexico, Mexico, 03100
      • RM Pharma Specialists S.A de C.V. /ID# 211879
    • Mexico City, Ciudad De Mexico, Mexico, 11850
      • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion S.C. /ID# 212946
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia S.A de C.V /ID# 211876
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
  • San Luis Potosi
    • San Luis Potosí, San Luis Potosi, Mexico, 78213
      • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
  • Yucatan
    • Mérida, Yucatan, Mexico, 97070
      • Medical Care & Research SA de CV /ID# 212682
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum /ID# 214424
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum /ID# 214413
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 214415
• New Zealand
  • Auckland
    • Papatoetoe, Auckland, New Zealand, 2025
      • Middlemore Clinical Trials /ID# 213504
    • Takapuna, Auckland, New Zealand, 0622
      • North Shore Hospital /ID# 213506
  • Waikato
    • Hamilton, Waikato, New Zealand, 3240
      • Waikato Hospital /ID# 213505
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 51-685
      • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-011
      • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-868
      • Centrum Medyczne Pratia Warszawa /ID# 218176
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-545
      • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
• Puerto Rico
  • San Juan, Puerto Rico, 00917-3104
    • GCM Medical Group PSC /ID# 211251
  • San Juan, Puerto Rico, 00918-3756
    • Mindful Medical Research /ID# 213384
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 211719
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 211757
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme /ID# 212721
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 211720
  • Alava
    • Vitoria, Alava, Spain, 01009
      • HUA - Txagorritxu /ID# 212520
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto /ID# 212722
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital Universitario de Galdakao /ID# 212803
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 211957
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital /ID# 212179
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 211752
  • Taipei City, Taiwan, 11031
    • Taipei Medical University Hospital /ID# 221600
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 212216
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 211751
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust /ID# 213189
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust /ID# 211838
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 211931
• United States
  • Arizona
    • Mesa, Arizona, United States, 85210-6871
      • Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
    • Phoenix, Arizona, United States, 85032-9306
      • AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
    • Phoenix, Arizona, United States, 85032-9306
      • AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401-6251
      • Arthritis and Rheumatism Associates /ID# 211411
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Rheumatic Studies Center, LLC /ID# 211600
    • La Palma, California, United States, 90623-1728
      • Arthritis & Osteo Medical Ctr /ID# 228235
    • Los Alamitos, California, United States, 90720-5402
      • Valerius Medical Group & Research Center /ID# 211599
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical /ID# 211638
    • Torrance, California, United States, 90502
      • The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
    • Tujunga, California, United States, 91042-2706
      • Medvin Clinical Research /ID# 211996
    • Upland, California, United States, 91786
      • Inland Rheum Clin Trials Inc. /ID# 213617
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 211314
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University /ID# 212824
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Health Research Institute /ID# 213335
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis & Rheumatic Disease Specialties /ID# 214052
    • Miami, Florida, United States, 33126
      • LeJenue Research Associates /ID# 212327
    • Miami, Florida, United States, 33173
      • Ctr Arthritis & Rheumatic Dise /ID# 212326
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research /ID# 219099
    • Plantation, Florida, United States, 33324
      • IRIS Research and Development, LLC /ID# 213053
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates /ID# 211881
    • Tampa, Florida, United States, 33614-7101
      • BayCare Medical Group, Inc. /ID# 218818
  • Illinois
    • Oak Brook, Illinois, United States, 60523-1245
      • Affinity Clinical Research /ID# 211496
    • Vernon Hills, Illinois, United States, 60061
      • Deerbrook Medical Associates /ID# 212251
  • Indiana
    • Evansville, Indiana, United States, 47714-0805
      • Qualmedica Research, LLC /ID# 214765
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics /ID# 215246
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research /ID# 211610
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 212321
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 211676
    • Lansing, Michigan, United States, 48910
      • June DO, PC /ID# 211674
  • Missouri
    • Saint Louis, Missouri, United States, 63131-1703
      • West County Rheumatology /ID# 225051
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
    • New York, New York, United States, 10016-2772
      • NYU Langone Orthopedic Center /ID# 213620
  • Ohio
    • Columbus, Ohio, United States, 43210-1229
      • Ohio State University - Wexner Medical Center /ID# 211636
    • Vandalia, Ohio, United States, 45377-9464
      • STAT Research, Inc. /ID# 211404
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-2117
      • Premier Rheumatology of Oklahoma /ID# 213850
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny Health Network Research Institute /ID# 211607
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Univ TN Health Sciences Ctr /ID# 212177
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta /ID# 213381
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc. /ID# 211521
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc. /ID# 214182
    • Carrollton, Texas, United States, 75007
      • Trinity Universal Research Associates - Carrollton /ID# 211527
    • Houston, Texas, United States, 77084
      • Accurate Clinical Management /ID# 213571
    • Lubbock, Texas, United States, 79424
      • West Texas Clinical Research /ID# 211529
    • Mesquite, Texas, United States, 75150
      • SW Rheumatology Res. LLC /ID# 211520
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic /ID# 213500
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center /ID# 211457
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology and Pulmonary Clinic /ID# 211398

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.

• 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:

- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: Placebo for elsubrutinib; Capsule; Oral; Drug: Placebo for upadacitinib; Film-coated tablet; Oral
Experimental: 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	Drug: Elsubrutinib; Capsule; Oral; Other Names: ABBV-105; Drug: Upadacitinib; Film-coated tablet; Oral; Other Names: RINVOQ
Experimental: 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	Drug: Placebo for elsubrutinib; Capsule; Oral; Drug: Upadacitinib; Film-coated tablet; Oral; Other Names: RINVOQ
Experimental: 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	Drug: Elsubrutinib; Capsule; Oral; Other Names: ABBV-105; Drug: Upadacitinib; Film-coated tablet; Oral; Other Names: RINVOQ
Experimental: 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	Drug: Elsubrutinib; Capsule; Oral; Other Names: ABBV-105; Drug: Placebo for upadacitinib; Film-coated tablet; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24	SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]); No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24	SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]); No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.	Baseline, Week 24
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24	BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.	Baseline, Week 24
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24	LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).	Baseline, Week 24
Change From Baseline in Daily Prednisone Dose at Week 24	Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.	From Baseline to Week 24
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24	The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.	From Baseline to Week 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• 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.

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Upadacitinib; Systemic Lupus Erythematosus (SLE); ABBV-599; ABBV-105; Elsubrutinib
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: M19-130; 2019-000638-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No