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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

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elsubrutinib
Placebo for Elsubrutinib
Upadacitinib
Placebo for Upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE) focused on measuring Systemic Lupus Erythematosus, ABBV-599, ABBV-105, ABT-494, Elsubrutinib, Upadacitinib

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
  • Wallace Rheumatic Studies Center, LLC /ID# 224374
  • Valerius Medical Group & Research Center /ID# 223922
  • East Bay Rheumatology Medical /ID# 225493
  • University of Colorado Hospital /ID# 245087
  • Arthritis & Rheumatic Disease Specialties /ID# 227828
  • Millennium Research /ID# 233192
  • IRIS Research and Development, LLC /ID# 227814
  • Deerbrook Medical Associates /ID# 227330
  • Qualmedica Research, LLC /ID# 227817
  • The Center for Rheumatology and Bone Research /ID# 225479
  • Beth Israel Deaconess Medical Center /ID# 222505
  • June DO, PC /ID# 221841
  • NYU Langone Health/NYU School of Medicine /ID# 245088
  • STAT Research, Inc. /ID# 221840
  • Allegheny Health Network Research Institute /ID# 245086
  • Dr. Ramesh Gupta /ID# 225524
  • Tekton Research, Inc. /ID# 224411
  • Accurate Clinical Management /ID# 225509
  • SW Rheumatology Res. LLC /ID# 225485
  • Carilion Clinic /ID# 227832
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569
  • Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893
  • CER Instituto Medico /ID# 223175
  • Aprillus Asistencia e Investigacion /ID# 221890
  • Instituto CAICI S.R.L /ID# 221892
  • Centro de Investigaciones Medicas Tucuman /ID# 221888
  • Investigaciones Clinicas Tucuman /ID# 221889
  • Rheumatology Research Unit Sunshine Coast /ID# 221816
  • Emeritus Research /ID# 223027
  • Monash Medical Centre /ID# 221814
  • UMHAT Sveti Ivan Rilski /ID# 223358
  • UMHAT Sveti Ivan Rilski /ID# 223359
  • Peking Union Medical College Hospital /ID# 222950
  • Guangdong Provincial People's Hospital /ID# 222851
  • Huashan Hospital, Fudan University /ID# 222929
  • People's Hospital of Xinjiang /ID# 222928
  • Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879
  • Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 221884
  • Preventive Care Sas /Id# 221881
  • Healthy Medical Center SAS /ID# 221882
  • Clinica Universitaria Bolivari /ID# 221880
  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964
  • Debreceni Egyetem Klinikai Kozpont /ID# 222480
  • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 222479
  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919
  • Chukyo Hospital /ID# 223398
  • NHO Nagoya Medical Center /ID# 222397
  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393
  • National Hospital Organization Asahikawa Medical Center /ID# 222394
  • EIRAKU Internal Medicine Clinic /ID# 222385
  • Tohoku University Hospital /ID# 222392
  • Shinshu University Hospital /ID# 222395
  • Saitama Medical Center /ID# 222389
  • Keio University Hospital /ID# 222498
  • Seoul National University Hospital /ID# 221897
  • RM Pharma Specialists S.A de C.V. /ID# 221915
  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913
  • Morales Vargas Centro de Investigacion S.C. /ID# 221912
  • Centro Integral en Reumatologia S.A de C.V /ID# 221914
  • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910
  • Medical Care & Research SA de CV /ID# 221911
  • North Shore Hospital /ID# 221850
  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430
  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859
  • MTZ Clinical Research Powered by Pratia /ID# 224431
  • GCM Medical Group PSC /ID# 224394
  • Mindful Medical Research /ID# 222513
  • HUA - Txagorritxu /ID# 221992
  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995
  • Hospital Universitario Basurto /ID# 221999
  • Hospital Universitario de Galdakao /ID# 221996
  • Hospital Universitario A Coruna - CHUAC /ID# 221993
  • Hospital Universitario 12 de Octubre /ID# 221994
  • Hospital Universitario Virgen de Valme /ID# 221997
  • Hospital Universitario y Politecnico La Fe /ID# 221998
  • China Medical University Hospital /ID# 221747
  • Taichung Veterans General Hospital /ID# 221748
  • National Taiwan University Hospital /ID# 221745
  • Taipei Medical University Hospital /ID# 227653
  • Taipei Veterans General Hosp /ID# 221746
  • Linkou Chang Gung Memorial Hospital /ID# 222469
  • Guys and St Thomas NHS Foundation Trust /ID# 221863
  • Manchester University NHS Foundation Trust /ID# 221861

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1: Elsubrutinib Dose A and Upadacitinib Dose A

Part 2: Elsubrutinib Dose A and Upadacitinib Dose B

Part 3: Elsubrutinib Dose A and Upadacitinib Placebo

Part 4: Elsubrutinib Placebo and Upadacitinib Dose A

Arm Description

Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).

Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.

Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.

Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.

Outcomes

Primary Outcome Measures

Number of Participants With 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 any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary Outcome Measures

Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.
Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
Change in Steroid Burden
Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.
Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)
SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.

Full Information

First Posted
June 29, 2020
Last Updated
January 16, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04451772
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
Keywords
Systemic Lupus Erythematosus, ABBV-599, ABBV-105, ABT-494, Elsubrutinib, Upadacitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).
Arm Title
Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.
Arm Title
Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
Arm Type
Experimental
Arm Description
Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.
Arm Title
Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.
Intervention Type
Drug
Intervention Name(s)
Elsubrutinib
Other Intervention Name(s)
ABBV-105
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for Elsubrutinib
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for Upadacitinib
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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 any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time Frame
Through Week 108
Secondary Outcome Measure Information:
Title
Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Description
SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.
Time Frame
Through Week 104
Title
Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)
Description
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
Time Frame
Through Week 104
Title
Change in Steroid Burden
Description
Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.
Time Frame
Baseline of M19-130 (Week 0) Through Week 104
Title
Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)
Description
SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.
Time Frame
Through Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
Wallace Rheumatic Studies Center, LLC /ID# 224374
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Valerius Medical Group & Research Center /ID# 223922
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Facility Name
East Bay Rheumatology Medical /ID# 225493
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
University of Colorado Hospital /ID# 245087
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties /ID# 227828
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Millennium Research /ID# 233192
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
IRIS Research and Development, LLC /ID# 227814
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 227330
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Qualmedica Research, LLC /ID# 227817
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-0805
Country
United States
Facility Name
The Center for Rheumatology and Bone Research /ID# 225479
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 222505
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
June DO, PC /ID# 221841
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
NYU Langone Health/NYU School of Medicine /ID# 245088
City
New York
State/Province
New York
ZIP/Postal Code
10016-2772
Country
United States
Facility Name
STAT Research, Inc. /ID# 221840
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Allegheny Health Network Research Institute /ID# 245086
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Dr. Ramesh Gupta /ID# 225524
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tekton Research, Inc. /ID# 224411
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Accurate Clinical Management /ID# 225509
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 225485
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Carilion Clinic /ID# 227832
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
CER Instituto Medico /ID# 223175
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Aprillus Asistencia e Investigacion /ID# 221890
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
Instituto CAICI S.R.L /ID# 221892
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Tucuman /ID# 221888
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigaciones Clinicas Tucuman /ID# 221889
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Rheumatology Research Unit Sunshine Coast /ID# 221816
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Emeritus Research /ID# 223027
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Monash Medical Centre /ID# 221814
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
UMHAT Sveti Ivan Rilski /ID# 223358
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 223359
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Peking Union Medical College Hospital /ID# 222950
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Guangdong Provincial People's Hospital /ID# 222851
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Huashan Hospital, Fudan University /ID# 222929
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
People's Hospital of Xinjiang /ID# 222928
City
Urumqi
ZIP/Postal Code
830001
Country
China
Facility Name
Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
80002
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 221884
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Preventive Care Sas /Id# 221881
City
Chia
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Healthy Medical Center SAS /ID# 221882
City
Zipaquira
State/Province
Cundinamarca
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Clinica Universitaria Bolivari /ID# 221880
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 222480
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 222479
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Chukyo Hospital /ID# 223398
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Facility Name
NHO Nagoya Medical Center /ID# 222397
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 222394
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
EIRAKU Internal Medicine Clinic /ID# 222385
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Facility Name
Tohoku University Hospital /ID# 222392
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Shinshu University Hospital /ID# 222395
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Saitama Medical Center /ID# 222389
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Keio University Hospital /ID# 222498
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Seoul National University Hospital /ID# 221897
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
RM Pharma Specialists S.A de C.V. /ID# 221915
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
03100
Country
Mexico
Facility Name
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 221912
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral en Reumatologia S.A de C.V /ID# 221914
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Medical Care & Research SA de CV /ID# 221911
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
North Shore Hospital /ID# 221850
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-545
Country
Poland
Facility Name
MTZ Clinical Research Powered by Pratia /ID# 224431
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Facility Name
GCM Medical Group PSC /ID# 224394
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 222513
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
HUA - Txagorritxu /ID# 221992
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 221999
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario de Galdakao /ID# 221996
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 221993
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 221994
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme /ID# 221997
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 221998
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
China Medical University Hospital /ID# 221747
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 221748
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 221745
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Medical University Hospital /ID# 227653
City
Taipei City
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 221746
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 222469
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 221863
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 221861
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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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