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

Last updated: December 19, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

2

Condition

Lupus

Systemic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Treatment

Placebo for Upadacitinib

Placebo for Elsubrutinib

Elsubrutinib

Clinical Study ID

NCT04451772
M20-186
2020-001690-72
  • Ages 18-65
  • All Genders

Study Summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms.

ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide.

Participants will receive the following for up to 56 weeks:

Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.

Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib,upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matchingplacebo) and will not have developed any laboratory or clinical discontinuationcriteria as defined in that study.

  • On stable background treatment for SLE throughout the study.

Exclusion

Exclusion Criteria:

  • Active, chronic, or recurrent viral, or bacterial infection.

  • Active tuberculosis (TB)

  • History of gastrointestinal (GI) perforation, diverticulitis, or a significantlyincreased risk for GI perforation per investigator assessment.

  • Participant require vaccination with live vaccine during study participation.

Study Design

Total Participants: 185
Treatment Group(s): 4
Primary Treatment: Placebo for Upadacitinib
Phase: 2
Study Start date:
July 27, 2020
Estimated Completion Date:
January 03, 2024

Connect with a study center

  • Aprillus Asistencia e Investig /ID# 221890

    Capital Federal, Buenos Aires 1046
    Argentina

    Site Not Available

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569

    Ciudad Autonoma Buenos Aires, Buenos Aires 1426
    Argentina

    Site Not Available

  • Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • CER Instituto Medico /ID# 223175

    Quilmes, Buenos Aires 1878
    Argentina

    Site Not Available

  • Aprillus Asistencia e Investigacion /ID# 221890

    Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires 1958
    Argentina

    Site Not Available

  • Instituto CAICI S.R.L /ID# 221892

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman /ID# 221888

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Investigaciones Clinicas Tucuman /ID# 221889

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Hospital Militar Central Ciruj /ID# 222569

    Buenos Aires, 1426
    Argentina

    Site Not Available

  • Hospital Cordoba /ID# 221894

    Cordoba, 5000
    Argentina

    Site Not Available

  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 221891

    Santa Fe, 2000
    Argentina

    Site Not Available

  • Emeritus Research Sydney /ID# 224340

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Rheumatology Research Unit Sunshine Coast /ID# 221816

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital /ID# 221817

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Emeritus Research /ID# 223027

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Monash Medical Centre /ID# 221814

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne /ID# 221813

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne /ID# 221813

    Fitzroy Melbourne, Victoria 3065
    Australia

    Site Not Available

  • UMHAT Kaspela EOOD /ID# 223360

    Plovdiv, 4001
    Bulgaria

    Site Not Available

  • UMHAT Sveti Ivan Rilski /ID# 223358

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Sveti Ivan Rilski /ID# 223359

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Toronto Western Hospital /ID# 221876

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke Inc. /ID# 221874

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Anhui Provincial Hospital /ID# 222854

    Hefei, Anhui 230001
    China

    Site Not Available

  • Duplicate_Peking Union Medical College Hospital /ID# 222950

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking Union Medical College Hospital /ID# 222950

    Beijing, Beijing 100730
    China

    Site Not Available

  • Guangdong Provincial People's Hospital /ID# 222851

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • People's Hospital of Xinjiang /ID# 222928

    Urumqi, Guizhou 830001
    China

    Site Not Available

  • Xiangya Hospital Central South University /ID# 222850

    Changsha, Hunan 410008
    China

    Site Not Available

  • Huashan Hospital, Fudan University /ID# 222929

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Jiangsu Province Hospital /ID# 222948

    Nanjing, 210029
    China

    Site Not Available

  • Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879

    Barranquilla, Atlantico 80002
    Colombia

    Site Not Available

  • Duplicate_Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879

    Barranquilla, Atlantico 80002
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 221884

    Bogota, Cundinamarca 110221
    Colombia

    Site Not Available

  • Duplicate_Centro de Investigacion en Reumatologia y Especialidades Medicas- CIRE /ID# 221884

    Bogota, Cundinamarca 110221
    Colombia

    Site Not Available

  • Preventive Care Sas /Id# 221881

    Chia, Cundinamarca 250001
    Colombia

    Site Not Available

  • Healthy Medical Center SAS /ID# 221882

    Zipaquira, Cundinamarca 250252
    Colombia

    Site Not Available

  • Healthy Medical Center S.A.S /ID# 221882

    Zipaquirá, Cundinamarca 250252
    Colombia

    Site Not Available

  • Clinica Universitaria Bolivari /ID# 221880

    Medellin, Valle Del Cauca 050034
    Colombia

    Site Not Available

  • Universitaetsklinikum Duesseldorf /ID# 222966

    Dusseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 222962

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963

    Berlin, 10117
    Germany

    Site Not Available

  • Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964

    Dresden, 01307
    Germany

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont /ID# 222480

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Site Not Available

  • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 222480

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Site Not Available

  • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 222479

    Veszprém, Veszprem 8200
    Hungary

    Site Not Available

  • Vital Medicina Kft /ID# 222479

    Veszprém, Veszprem 8200
    Hungary

    Site Not Available

  • Orszagos Reumatologiai es Fizi /ID# 223834

    Budapest, 1023
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 223835

    Gyula, 5700
    Hungary

    Site Not Available

  • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 222479

    Veszprem, 8200
    Hungary

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919

    Cona, Ferrara 44124
    Italy

    Site Not Available

  • Duplicate_Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919

    Cona, Ferrara 44124
    Italy

    Site Not Available

  • AOU Policlinico Umberto I /ID# 221917

    Rome, Lazio 00185
    Italy

    Site Not Available

  • Azienda Istituto Gaetano Pini /ID# 221916

    Milan, 20122
    Italy

    Site Not Available

  • AOU Pisana /ID# 221920

    Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221918

    Udine, 33100
    Italy

    Site Not Available

  • Chukyo Hospital /ID# 223398

    Nagoya-shi, Aichi 457-8510
    Japan

    Site Not Available

  • NHO Nagoya Medical Center /ID# 222397

    Nagoya-shi, Aichi 460-0001
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499

    Kitakyushu-shi, Fukuoka 807-8556
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393

    Hiroshima-shi, Hiroshima 730-8619
    Japan

    Site Not Available

  • National Hospital Organization Asahikawa Medical Center /ID# 222394

    Asahikawa-shi, Hokkaido 070-8644
    Japan

    Site Not Available

  • Tomakomai City Hospital /ID# 222398

    Tomakomai-shi, Hokkaido 053-0034
    Japan

    Site Not Available

  • EIRAKU Internal Medicine Clinic /ID# 222385

    Kagoshima-shi, Kagoshima 890-0063
    Japan

    Site Not Available

  • Tohoku University Hospital /ID# 222392

    Sendai-shi, Miyagi 9808574
    Japan

    Site Not Available

  • Shinshu University Hospital /ID# 222395

    Matsumoto-shi, Nagano 390-8621
    Japan

    Site Not Available

  • Saitama Medical Center /ID# 222389

    Kawagoe-shi, Saitama 350-8550
    Japan

    Site Not Available

  • Keio University Hospital /ID# 222498

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Ajou University Hospital /ID# 221899

    Suwon, Gyeonggido 16499
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital /ID# 221897

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • KonKuk University Medical Center /ID# 221898

    광진구, Seoul Teugbyeolsi 05030
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital /ID# 221901

    Gwangju, 61469
    Korea, Republic of

    Site Not Available

  • Inha University Hospital /ID# 221900

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913

    Mexico City, Ciudad De Mexico 11850
    Mexico

    Site Not Available

  • RM Pharma Specialists S.A de C.V. /ID# 221915

    Mexico City, Ciudad De Mexico 03100
    Mexico

    Site Not Available

  • Morales Vargas Centro de Investigacion S.C. /ID# 221912

    Leon, Guanajuato 37000
    Mexico

    Site Not Available

  • Centro Integral en Reumatologia S.A de C.V /ID# 221914

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910

    Guadalajara, Jalisco 44690
    Mexico

    Site Not Available

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 223389

    San Luis Potosí, San Luis Potosi 78213
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV /ID# 221911

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Vrije Universiteit Medisch Centrum /ID# 221776

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum /ID# 221774

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht /ID# 221775

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • North Shore Hospital /ID# 221850

    Takapuna, Auckland 0622
    New Zealand

    Site Not Available

  • Waikato Hospital /ID# 221852

    Hamilton, Waikato 3204
    New Zealand

    Site Not Available

  • North Shore Hospital /ID# 221850

    Auckland, 0622
    New Zealand

    Site Not Available

  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860

    Wroclaw, Dolnoslaskie 51-685
    Poland

    Site Not Available

  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860

    Wrocław, Dolnoslaskie 51-685
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430

    Krakow, Malopolskie 31-011
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia /ID# 224431

    Warszawa, Mazowieckie 02-172
    Poland

    Site Not Available

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859

    Poznan, Wielkopolskie 61-545
    Poland

    Site Not Available

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859

    Poznań, 61-545
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Warszawa /ID# 224431

    Warsaw, 01-868
    Poland

    Site Not Available

  • GCM Medical Group PSC /ID# 224394

    San Juan, 00917-3104
    Puerto Rico

    Site Not Available

  • Mindful Medical Research /ID# 222513

    San Juan, 00918-3756
    Puerto Rico

    Site Not Available

  • Hospital Universitario A Coruña - CHUAC /ID# 221993

    A Coruña, A Coruna 15006
    Spain

    Site Not Available

  • HUA - Txagorritxu /ID# 221992

    Vitoria, Alava 01009
    Spain

    Site Not Available

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Basurto /ID# 221999

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital Universitario de Galdakao /ID# 221996

    Galdakao, Vizcaya 48960
    Spain

    Site Not Available

  • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 221993

    A Coruna, 15006
    Spain

    Site Not Available

  • Hospital Universitario A Coruna - CHUAC /ID# 221993

    A Coruna, 15006
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre /ID# 221994

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Valme /ID# 221997

    Sevilla, 41014
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 221998

    Valencia, 46026
    Spain

    Site Not Available

  • Taichung Veterans General Hospital /ID# 221748

    Taichung, Keelung 40705
    Taiwan

    Site Not Available

  • Taipei Veterans General Hosp /ID# 221746

    Taipei, Keelung 11217
    Taiwan

    Site Not Available

  • National Taiwan University Hospital /ID# 221745

    Taipei City, Taipei 100
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 221747

    Taichung, 40447
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 221747

    Taichung City, 40447
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital /ID# 227653

    Taipei City, 11031
    Taiwan

    Site Not Available

  • Taipei Veterans General Hosp /ID# 221746

    Taipei City, 11217
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 222469

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust /ID# 221863

    London, London, City Of SE1 9RT
    United Kingdom

    Site Not Available

  • Duplicate_Manchester University NHS Foundation Trust /ID# 221861

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust /ID# 221861

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 227833

    Phoenix, Arizona 85032-9306
    United States

    Site Not Available

  • Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833

    Phoenix, Arizona 85032-9306
    United States

    Site Not Available

  • Wallace Rheumatic Studies Center, LLC /ID# 224374

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Valerius Medical Group & Research Center /ID# 223922

    Los Alamitos, California 90720-5402
    United States

    Site Not Available

  • East Bay Rheumatology Medical /ID# 225493

    San Leandro, California 94578
    United States

    Site Not Available

  • Medvin Clinical Research /ID# 227820

    Tujunga, California 91042-2706
    United States

    Site Not Available

  • University of Colorado Hospital /ID# 245087

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Arthritis & Rheumatic Disease Specialties /ID# 227828

    Aventura, Florida 33180
    United States

    Site Not Available

  • Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828

    Aventura, Florida 33180
    United States

    Site Not Available

  • Millennium Research /ID# 233192

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • IRIS Research and Development, LLC /ID# 227814

    Plantation, Florida 33324
    United States

    Site Not Available

  • Deerbrook Medical Associates /ID# 227330

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Deerbrook Medical Associates /ID# 227330

    Vernon Hills, Illinois 60061
    United States

    Site Not Available

  • Qualmedica Research, LLC /ID# 227817

    Evansville, Indiana 47714-0805
    United States

    Site Not Available

  • The Center for Rheumatology and Bone Research /ID# 225479

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center /ID# 222505

    Boston, Massachusetts 02215-5400
    United States

    Site Not Available

  • Henry Ford Health System /ID# 233194

    Detroit, Michigan 48202
    United States

    Site Not Available

  • June DO, PC /ID# 221841

    Lansing, Michigan 48911
    United States

    Site Not Available

  • NYU Langone Ambulatory Care Brooklyn Heights /ID# 233193

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088

    New York, New York 10016-2772
    United States

    Site Not Available

  • NYU Langone Health/NYU School of Medicine /ID# 245088

    New York, New York 10016-2772
    United States

    Site Not Available

  • Ohio State University - Wexner Medical Center /ID# 240500

    Columbus, Ohio 43210-1229
    United States

    Site Not Available

  • STAT Research, Inc. /ID# 221840

    Vandalia, Ohio 45377-9464
    United States

    Site Not Available

  • Allegheny Health Network Research Institute /ID# 245086

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Dr. Ramesh Gupta /ID# 225524

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Tekton Research, Inc. /ID# 224411

    Austin, Texas 78745
    United States

    Site Not Available

  • Accurate Clinical Management /ID# 225509

    Baytown, Texas 77521
    United States

    Site Not Available

  • Accurate Clinical Management /ID# 225509

    Houston, Texas 77084
    United States

    Site Not Available

  • SW Rheumatology Res. LLC /ID# 225485

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Carilion Clinic /ID# 227832

    Roanoke, Virginia 24016
    United States

    Site Not Available

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