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
A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
2 other identifiers
interventional
185
18 countries
87
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Typical duration for phase_2
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2024
CompletedResults Posted
Study results publicly available
January 14, 2025
CompletedJanuary 14, 2025
December 1, 2024
3.4 years
June 29, 2020
December 19, 2024
December 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
Secondary Outcomes (4)
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Change From Baseline in Daily Prednisone Dose Over Time
Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
From Week 56 through Week 104
Study Arms (6)
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose
EXPERIMENTALParticipants 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 placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg
EXPERIMENTALParticipants 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.
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose
EXPERIMENTALParticipants 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.
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose
EXPERIMENTALParticipants 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 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo
EXPERIMENTALParticipants 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 placebo/upadacitinib placebo -> ABBV-599 Low Dose
EXPERIMENTALParticipants 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.
Interventions
Capsule; Oral
Capsule; Oral
Film-coated tablet; Oral
Film-coated tablet; Oral
Eligibility Criteria
You may qualify if:
- Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 \[elsubrutinib/upadacitinib\] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
- On stable background treatment for SLE throughout the study.
You may not qualify if:
- Active, chronic, or recurrent viral, or bacterial infection.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (87)
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
Phoenix, Arizona, 85032-9306, United States
Wallace Rheumatic Studies Center, LLC /ID# 224374
Beverly Hills, California, 90211, United States
Valerius Medical Group & Research Center /ID# 223922
Los Alamitos, California, 90720-5402, United States
East Bay Rheumatology Medical /ID# 225493
San Leandro, California, 94578, United States
University of Colorado Hospital /ID# 245087
Aurora, Colorado, 80045, United States
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828
Aventura, Florida, 33180, United States
Millennium Research /ID# 233192
Ormond Beach, Florida, 32174, United States
IRIS Research and Development, LLC /ID# 227814
Plantation, Florida, 33324, United States
Deerbrook Medical Associates /ID# 227330
Libertyville, Illinois, 60048, United States
Qualmedica Research, LLC /ID# 227817
Evansville, Indiana, 47714-0805, United States
The Center for Rheumatology and Bone Research /ID# 225479
Wheaton, Maryland, 20902, United States
Beth Israel Deaconess Medical Center /ID# 222505
Boston, Massachusetts, 02215-5400, United States
June DO, PC /ID# 221841
Lansing, Michigan, 48911, United States
Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088
New York, New York, 10016-2772, United States
STAT Research, Inc. /ID# 221840
Vandalia, Ohio, 45377-9464, United States
Allegheny Health Network Research Institute /ID# 245086
Pittsburgh, Pennsylvania, 15224, United States
Dr. Ramesh Gupta /ID# 225524
Memphis, Tennessee, 38119, United States
Tekton Research, Inc. /ID# 224411
Austin, Texas, 78745, United States
Accurate Clinical Management /ID# 225509
Houston, Texas, 77084, United States
SW Rheumatology Res. LLC /ID# 225485
Mesquite, Texas, 75150, United States
Carilion Clinic /ID# 227832
Roanoke, Virginia, 24016, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569
Ciudad Autonoma Buenos Aires, Buenos Aires, 1426, Argentina
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893
La Plata, Buenos Aires, 1900, Argentina
CER Instituto Medico /ID# 223175
Quilmes, Buenos Aires, 1878, Argentina
Aprillus Asistencia e Investigacion /ID# 221890
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1958, Argentina
Instituto CAICI S.R.L /ID# 221892
Rosario, Santa Fe Province, 2000, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 221888
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigaciones Clinicas Tucuman /ID# 221889
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Rheumatology Research Unit Sunshine Coast /ID# 221816
Maroochydore, Queensland, 4558, Australia
Emeritus Research /ID# 223027
Camberwell, Victoria, 3124, Australia
Monash Medical Centre /ID# 221814
Clayton, Victoria, 3168, Australia
UMHAT Sveti Ivan Rilski /ID# 223358
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223359
Sofia, 1431, Bulgaria
Duplicate_Peking Union Medical College Hospital /ID# 222950
Beijing, Beijing Municipality, 100730, China
Guangdong Provincial People's Hospital /ID# 222851
Guangzhou, Guangdong, 510080, China
People's Hospital of Xinjiang /ID# 222928
Urumqi, Guizhou, 830001, China
Huashan Hospital, Fudan University /ID# 222929
Shanghai, Shanghai Municipality, 200040, China
Duplicate_Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879
Barranquilla, Atlántico, 80002, Colombia
Duplicate_Centro de Investigacion en Reumatologia y Especialidades Medicas- CIRE /ID# 221884
Bogota, Cundinamarca, 110221, Colombia
Preventive Care Sas /Id# 221881
Chía, Cundinamarca, 250001, Colombia
Healthy Medical Center S.A.S /ID# 221882
Zipaquirá, Cundinamarca, 250252, Colombia
Clinica Universitaria Bolivari /ID# 221880
Medellin, Valle del Cauca Department, 050034, Colombia
Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963
Berlin, 10117, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964
Dresden, 01307, Germany
Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 222480
Debrecen, Hajdú-Bihar, 4032, Hungary
Vital Medicina Kft /ID# 222479
Veszprém, Veszprém megye, 8200, Hungary
Duplicate_Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919
Cona, Ferrara, 44124, Italy
Chukyo Hospital /ID# 223398
Nagoya, Aichi-ken, 457-8510, Japan
NHO Nagoya Medical Center /ID# 222397
Nagoya, Aichi-ken, 460-0001, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393
Hiroshima, Hiroshima, 730-8619, Japan
National Hospital Organization Asahikawa Medical Center /ID# 222394
Asahikawa-shi, Hokkaido, 070-8644, Japan
EIRAKU Internal Medicine Clinic /ID# 222385
Kagoshima, Kagoshima-ken, 890-0063, Japan
Tohoku University Hospital /ID# 222392
Sendai, Miyagi, 9808574, Japan
Shinshu University Hospital /ID# 222395
Matsumoto-shi, Nagano, 390-8621, Japan
Saitama Medical Center /ID# 222389
Kawagoe-shi, Saitama, 350-8550, Japan
Keio University Hospital /ID# 222498
Shinjuku-ku, Tokyo, 160-8582, Japan
Morales Vargas Centro de Investigacion S.C. /ID# 221912
León, Guanajuato, 37000, Mexico
Centro Integral en Reumatologia S.A de C.V /ID# 221914
Guadalajara, Jalisco, 44160, Mexico
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910
Guadalajara, Jalisco, 44690, Mexico
RM Pharma Specialists S.A de C.V. /ID# 221915
Mexico City, Mexico City, 03100, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913
Mexico City, Mexico City, 11850, Mexico
Medical Care & Research SA de CV /ID# 221911
Mérida, Yucatán, 97070, Mexico
North Shore Hospital /ID# 221850
Takapuna, Auckland, 0622, New Zealand
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859
Poznan, Greater Poland Voivodeship, 61-545, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430
Krakow, Lesser Poland Voivodeship, 31-011, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
MTZ Clinical Research Powered by Pratia /ID# 224431
Warsaw, Masovian Voivodeship, 02-172, Poland
GCM Medical Group PSC /ID# 224394
San Juan, 00917-3104, Puerto Rico
Mindful Medical Research /ID# 222513
San Juan, 00918-3756, Puerto Rico
Seoul National University Hospital /ID# 221897
Seoul, Seoul Teugbyeolsi, 03080, South Korea
HUA - Txagorritxu /ID# 221992
Vitoria-Gasteiz, Alava, 01009, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Basurto /ID# 221999
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario de Galdakao /ID# 221996
Galdakao, Vizcaya, 48960, Spain
Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 221993
A Coruña, 15006, Spain
Hospital Universitario 12 de Octubre /ID# 221994
Madrid, 28041, Spain
Hospital Universitario Virgen de Valme /ID# 221997
Seville, 41014, Spain
Hospital Universitario y Politecnico La Fe /ID# 221998
Valencia, 46026, Spain
Taichung Veterans General Hospital /ID# 221748
Taichung, Keelung, 40705, Taiwan
Taipei Veterans General Hosp /ID# 221746
Taipei, Keelung, 11217, Taiwan
National Taiwan University Hospital /ID# 221745
Taipei City, Taipei, 100, Taiwan
China Medical University Hospital /ID# 221747
Taichung, 40447, Taiwan
Taipei Medical University Hospital /ID# 227653
Taipei, 11031, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222469
Taoyuan, 333, Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 221863
London, London, City of, SE1 9RT, United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 221861
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2020
First Posted
June 30, 2020
Study Start
July 27, 2020
Primary Completion
January 3, 2024
Study Completion
January 3, 2024
Last Updated
January 14, 2025
Results First Posted
January 14, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.