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
NCT ID: NCT04451772
Last Updated: 2025-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2020-07-27
2024-01-03
Brief Summary
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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.
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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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ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg
Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Placebo for Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose
Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Elsubrutinib
Capsule; Oral
Upadacitinib
Film-coated tablet; Oral
Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo
Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Elsubrutinib
Capsule; Oral
Placebo for Upadacitinib
Film-coated tablet; Oral
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low Dose
Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
Elsubrutinib
Capsule; Oral
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
* On stable background treatment for SLE throughout the study.
Exclusion Criteria
* Active tuberculosis (TB)
* History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
* Participant require vaccination with live vaccine during study participation.
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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Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
Phoenix, Arizona, United States
Wallace Rheumatic Studies Center, LLC /ID# 224374
Beverly Hills, California, United States
Valerius Medical Group & Research Center /ID# 223922
Los Alamitos, California, United States
East Bay Rheumatology Medical /ID# 225493
San Leandro, California, United States
University of Colorado Hospital /ID# 245087
Aurora, Colorado, United States
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828
Aventura, Florida, United States
Millennium Research /ID# 233192
Ormond Beach, Florida, United States
IRIS Research and Development, LLC /ID# 227814
Plantation, Florida, United States
Deerbrook Medical Associates /ID# 227330
Libertyville, Illinois, United States
Qualmedica Research, LLC /ID# 227817
Evansville, Indiana, United States
The Center for Rheumatology and Bone Research /ID# 225479
Wheaton, Maryland, United States
Beth Israel Deaconess Medical Center /ID# 222505
Boston, Massachusetts, United States
June DO, PC /ID# 221841
Lansing, Michigan, United States
Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088
New York, New York, United States
STAT Research, Inc. /ID# 221840
Vandalia, Ohio, United States
Allegheny Health Network Research Institute /ID# 245086
Pittsburgh, Pennsylvania, United States
Dr. Ramesh Gupta /ID# 225524
Memphis, Tennessee, United States
Tekton Research, Inc. /ID# 224411
Austin, Texas, United States
Accurate Clinical Management /ID# 225509
Houston, Texas, United States
SW Rheumatology Res. LLC /ID# 225485
Mesquite, Texas, United States
Carilion Clinic /ID# 227832
Roanoke, Virginia, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893
La Plata, Buenos Aires, Argentina
CER Instituto Medico /ID# 223175
Quilmes, Buenos Aires, Argentina
Aprillus Asistencia e Investigacion /ID# 221890
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Instituto CAICI S.R.L /ID# 221892
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 221888
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman /ID# 221889
San Miguel de Tucumán, Tucumán Province, Argentina
Rheumatology Research Unit Sunshine Coast /ID# 221816
Maroochydore, Queensland, Australia
Emeritus Research /ID# 223027
Camberwell, Victoria, Australia
Monash Medical Centre /ID# 221814
Clayton, Victoria, Australia
UMHAT Sveti Ivan Rilski /ID# 223358
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223359
Sofia, , Bulgaria
Duplicate_Peking Union Medical College Hospital /ID# 222950
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital /ID# 222851
Guangzhou, Guangdong, China
People's Hospital of Xinjiang /ID# 222928
Urumqi, Guizhou, China
Huashan Hospital, Fudan University /ID# 222929
Shanghai, Shanghai Municipality, China
Duplicate_Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879
Barranquilla, Atlántico, Colombia
Duplicate_Centro de Investigacion en Reumatologia y Especialidades Medicas- CIRE /ID# 221884
Bogota, Cundinamarca, Colombia
Preventive Care Sas /Id# 221881
Chía, Cundinamarca, Colombia
Healthy Medical Center S.A.S /ID# 221882
Zipaquirá, Cundinamarca, Colombia
Clinica Universitaria Bolivari /ID# 221880
Medellin, Valle del Cauca Department, Colombia
Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964
Dresden, , Germany
Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 222480
Debrecen, Hajdú-Bihar, Hungary
Vital Medicina Kft /ID# 222479
Veszprém, Veszprém megye, Hungary
Duplicate_Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919
Cona, Ferrara, Italy
Chukyo Hospital /ID# 223398
Nagoya, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 222397
Nagoya, Aichi-ken, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499
Kitakyushu-shi, Fukuoka, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393
Hiroshima, Hiroshima, Japan
National Hospital Organization Asahikawa Medical Center /ID# 222394
Asahikawa-shi, Hokkaido, Japan
EIRAKU Internal Medicine Clinic /ID# 222385
Kagoshima, Kagoshima-ken, Japan
Tohoku University Hospital /ID# 222392
Sendai, Miyagi, Japan
Shinshu University Hospital /ID# 222395
Matsumoto-shi, Nagano, Japan
Saitama Medical Center /ID# 222389
Kawagoe-shi, Saitama, Japan
Keio University Hospital /ID# 222498
Shinjuku-ku, Tokyo, Japan
Morales Vargas Centro de Investigacion S.C. /ID# 221912
León, Guanajuato, Mexico
Centro Integral en Reumatologia S.A de C.V /ID# 221914
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910
Guadalajara, Jalisco, Mexico
RM Pharma Specialists S.A de C.V. /ID# 221915
Mexico City, Mexico City, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913
Mexico City, Mexico City, Mexico
Medical Care & Research SA de CV /ID# 221911
Mérida, Yucatán, Mexico
North Shore Hospital /ID# 221850
Takapuna, Auckland, New Zealand
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859
Poznan, Greater Poland Voivodeship, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430
Krakow, Lesser Poland Voivodeship, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860
Wroclaw, Lower Silesian Voivodeship, Poland
MTZ Clinical Research Powered by Pratia /ID# 224431
Warsaw, Masovian Voivodeship, Poland
GCM Medical Group PSC /ID# 224394
San Juan, , Puerto Rico
Mindful Medical Research /ID# 222513
San Juan, , Puerto Rico
Seoul National University Hospital /ID# 221897
Seoul, Seoul Teugbyeolsi, South Korea
HUA - Txagorritxu /ID# 221992
Vitoria-Gasteiz, Alava, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995
Sabadell, Barcelona, Spain
Hospital Universitario Basurto /ID# 221999
Bilbao, Vizcaya, Spain
Hospital Universitario de Galdakao /ID# 221996
Galdakao, Vizcaya, Spain
Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 221993
A Coruña, , Spain
Hospital Universitario 12 de Octubre /ID# 221994
Madrid, , Spain
Hospital Universitario Virgen de Valme /ID# 221997
Seville, , Spain
Hospital Universitario y Politecnico La Fe /ID# 221998
Valencia, , Spain
Taichung Veterans General Hospital /ID# 221748
Taichung, Keelung, Taiwan
Taipei Veterans General Hosp /ID# 221746
Taipei, Keelung, Taiwan
National Taiwan University Hospital /ID# 221745
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 221747
Taichung, , Taiwan
Taipei Medical University Hospital /ID# 227653
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222469
Taoyuan, , Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 221863
London, London, City of, United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 221861
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001690-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-186
Identifier Type: -
Identifier Source: org_study_id
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