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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)

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status
Completed
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 (SLE), ABBV-105, Upadacitinib, ABBV-599, Elsubrutinib

Eligibility Criteria

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

Inclusion Criteria:

  • Participant has clinical diagnosis of 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 >= 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 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, at 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.

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
  • Arthritis and Rheumatism Associates /ID# 211411
  • Wallace Rheumatic Studies Center, LLC /ID# 211600
  • Arthritis & Osteo Medical Ctr /ID# 228235
  • Valerius Medical Group & Research Center /ID# 211599
  • East Bay Rheumatology Medical /ID# 211638
  • The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
  • Medvin Clinical Research /ID# 211996
  • Inland Rheum Clin Trials Inc. /ID# 213617
  • University of Colorado Hospital /ID# 211314
  • Yale University /ID# 212824
  • Medstar Health Research Institute /ID# 213335
  • Arthritis & Rheumatic Disease Specialties /ID# 214052
  • LeJenue Research Associates /ID# 212327
  • Ctr Arthritis & Rheumatic Dise /ID# 212326
  • Millennium Research /ID# 219099
  • IRIS Research and Development, LLC /ID# 213053
  • West Broward Rheumatology Associates /ID# 211881
  • BayCare Medical Group, Inc. /ID# 218818
  • Affinity Clinical Research /ID# 211496
  • Deerbrook Medical Associates /ID# 212251
  • Qualmedica Research, LLC /ID# 214765
  • University of Iowa Hospitals and Clinics /ID# 215246
  • The Center for Rheumatology and Bone Research /ID# 211610
  • Beth Israel Deaconess Medical Center /ID# 212321
  • Henry Ford Health System /ID# 211676
  • June DO, PC /ID# 211674
  • West County Rheumatology /ID# 225051
  • NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
  • NYU Langone Orthopedic Center /ID# 213620
  • Ohio State University - Wexner Medical Center /ID# 211636
  • STAT Research, Inc. /ID# 211404
  • Premier Rheumatology of Oklahoma /ID# 213850
  • Allegheny Health Network Research Institute /ID# 211607
  • Univ TN Health Sciences Ctr /ID# 212177
  • Dr. Ramesh Gupta /ID# 213381
  • Tekton Research, Inc. /ID# 211521
  • Tekton Research, Inc. /ID# 214182
  • Trinity Universal Research Associates - Carrollton /ID# 211527
  • Accurate Clinical Management /ID# 213571
  • West Texas Clinical Research /ID# 211529
  • SW Rheumatology Res. LLC /ID# 211520
  • Carilion Clinic /ID# 213500
  • Virginia Mason Medical Center /ID# 211457
  • Rheumatology and Pulmonary Clinic /ID# 211398
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
  • Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
  • CER Instituto Medico /ID# 222757
  • Aprillus Asistencia e Investigacion /ID# 211630
  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
  • Instituto CAICI S.R.L /ID# 211633
  • Centro de Investigaciones Medicas Tucuman /ID# 212714
  • Investigaciones Clinicas Tucuman /ID# 211942
  • Hospital Cordoba /ID# 212200
  • Emeritus Research Sydney /ID# 222983
  • Royal North Shore Hospital /ID# 222982
  • Royal Brisbane and Women's Hospital /ID# 212667
  • Rheumatology Research Unit Sunshine Coast /ID# 211902
  • Griffith University /ID# 223543
  • The Queen Elizabeth Hospital /ID# 211901
  • Emeritus Research /ID# 211903
  • Monash Medical Centre /ID# 212313
  • St Vincent's Hospital Melbourne /ID# 212311
  • UMHAT Kaspela EOOD /ID# 223141
  • UMHAT Sveti Ivan Rilski /ID# 223139
  • UMHAT Sveti Ivan Rilski /ID# 223140
  • Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
  • St. Josephs Health Care Centre /ID# 212331
  • Toronto Western Hospital /ID# 213336
  • Diex Recherche Sherbrooke Inc. /ID# 217734
  • Anhui Provincial Hospital /ID# 211812
  • Peking Union Medical College Hospital /ID# 211614
  • Guangdong Provincial People's Hospital /ID# 211811
  • Xiangya Hospital Central South University /ID# 212919
  • Jiangsu Province Hospital /ID# 211818
  • Huashan Hospital, Fudan University /ID# 213976
  • Shanghai Changhai Hospital /ID# 211819
  • People's Hospital of Xinjiang /ID# 211821
  • Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
  • Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
  • Preventive Care Sas /Id# 211896
  • Healthy Medical Center SAS /ID# 211899
  • Clinica Universitaria Bolivari /ID# 211897
  • CHRU Lille - Hopital Claude Huriez /ID# 211829
  • CHU Bordeaux - Hopital Pellegrin /ID# 211832
  • AP-HP - Hôpital Bicêtre /ID# 211968
  • Hopital Pitie Salpetriere /ID# 211831
  • CHU Strasbourg - Hopital Civil /ID# 211981
  • Universitaetsklinikum Duesseldorf /ID# 212408
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
  • Debreceni Egyetem Klinikai Kozpont /ID# 212042
  • Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
  • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
  • ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
  • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
  • Chukyo Hospital /ID# 222625
  • NHO Nagoya Medical Center /ID# 213974
  • Hamanomachi Hospital /ID# 213696
  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
  • Fukushima Medical University Hospital /ID# 213913
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
  • National Hospital Organization Asahikawa Medical Center /ID# 213846
  • Tomakomai City Hospital /ID# 214234
  • Kita-harima Medical Center /ID# 215474
  • EIRAKU Internal Medicine Clinic /ID# 215419
  • Yokohama Rosai Hospital /ID# 213690
  • Kumamoto Shinto General Hospital /ID# 215347
  • Tohoku University Hospital /ID# 213693
  • Shinshu University Hospital /ID# 213853
  • Nagano Red Cross Hospital /ID# 214572
  • Saitama Medical Center /ID# 213687
  • Keio University Hospital /ID# 216347
  • Ajou University Hospital /ID# 211692
  • KonKuk University Medical Center /ID# 213410
  • Chonnam National University Hospital /ID# 211695
  • Inha University Hospital /ID# 211691
  • Seoul National University Hospital /ID# 211740
  • RM Pharma Specialists S.A de C.V. /ID# 211879
  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
  • Morales Vargas Centro de Investigacion S.C. /ID# 212946
  • Centro Integral en Reumatologia S.A de C.V /ID# 211876
  • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
  • Medical Care & Research SA de CV /ID# 212682
  • Vrije Universiteit Medisch Centrum /ID# 214424
  • Leids Universitair Medisch Centrum /ID# 214413
  • Universitair Medisch Centrum Utrecht /ID# 214415
  • Middlemore Clinical Trials /ID# 213504
  • North Shore Hospital /ID# 213506
  • Waikato Hospital /ID# 213505
  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
  • Centrum Medyczne Pratia Warszawa /ID# 218176
  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
  • GCM Medical Group PSC /ID# 211251
  • Mindful Medical Research /ID# 213384
  • HUA - Txagorritxu /ID# 212520
  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
  • Hospital Universitario Basurto /ID# 212722
  • Hospital Universitario de Galdakao /ID# 212803
  • Hospital Universitario A Coruna - CHUAC /ID# 211719
  • Hospital Universitario 12 de Octubre /ID# 211757
  • Hospital Universitario Virgen de Valme /ID# 212721
  • Hospital Universitario y Politecnico La Fe /ID# 211720
  • China Medical University Hospital /ID# 212179
  • Taichung Veterans General Hospital /ID# 211957
  • National Taiwan University Hospital /ID# 211752
  • Taipei Medical University Hospital /ID# 221600
  • Taipei Veterans General Hosp /ID# 212216
  • Linkou Chang Gung Memorial Hospital /ID# 211751
  • Guys and St Thomas NHS Foundation Trust /ID# 211931
  • Cambridge University Hospitals NHS Foundation Trust /ID# 213189
  • Manchester University NHS Foundation Trust /ID# 211838

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Elsubrutinib placebo/upadacitinib placebo

ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)

Elsubrutinib placebo/upadacitinib 30 mg

ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)

Elsubrutinib 60 mg/upadacitinib placebo

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.

Full Information

First Posted
June 3, 2019
Last Updated
June 27, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03978520
Brief Title
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)
Acronym
SLEek
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
January 19, 2022 (Actual)
Study Completion Date
July 14, 2022 (Actual)

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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 (SLE), ABBV-105, Upadacitinib, ABBV-599, Elsubrutinib

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Elsubrutinib placebo/upadacitinib placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
Elsubrutinib placebo/upadacitinib 30 mg
Arm Type
Experimental
Arm Description
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
Arm Title
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
Elsubrutinib 60 mg/upadacitinib placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Elsubrutinib
Other Intervention Name(s)
ABBV-105
Intervention Description
Capsule; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo for elsubrutinib
Intervention Description
Capsule; Oral
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ
Intervention Description
Film-coated tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo for upadacitinib
Intervention Description
Film-coated tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
Description
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.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
Description
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.
Time Frame
Baseline, Week 24
Title
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
Description
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).
Time Frame
Baseline, Week 24
Title
Change From Baseline in Daily Prednisone Dose at Week 24
Description
Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
Time Frame
From Baseline to Week 24
Title
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Description
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.
Time Frame
From Baseline to Week 24

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210-6871
Country
United States
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
Arthritis and Rheumatism Associates /ID# 211411
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401-6251
Country
United States
Facility Name
Wallace Rheumatic Studies Center, LLC /ID# 211600
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Arthritis & Osteo Medical Ctr /ID# 228235
City
La Palma
State/Province
California
ZIP/Postal Code
90623-1728
Country
United States
Facility Name
Valerius Medical Group & Research Center /ID# 211599
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Facility Name
East Bay Rheumatology Medical /ID# 211638
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Medvin Clinical Research /ID# 211996
City
Tujunga
State/Province
California
ZIP/Postal Code
91042-2706
Country
United States
Facility Name
Inland Rheum Clin Trials Inc. /ID# 213617
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University of Colorado Hospital /ID# 211314
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University /ID# 212824
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Medstar Health Research Institute /ID# 213335
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties /ID# 214052
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
LeJenue Research Associates /ID# 212327
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Ctr Arthritis & Rheumatic Dise /ID# 212326
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Millennium Research /ID# 219099
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
IRIS Research and Development, LLC /ID# 213053
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
West Broward Rheumatology Associates /ID# 211881
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 218818
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
Affinity Clinical Research /ID# 211496
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 212251
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Qualmedica Research, LLC /ID# 214765
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714-0805
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 215246
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The Center for Rheumatology and Bone Research /ID# 211610
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 212321
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Henry Ford Health System /ID# 211676
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
June DO, PC /ID# 211674
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
West County Rheumatology /ID# 225051
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131-1703
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
NYU Langone Orthopedic Center /ID# 213620
City
New York
State/Province
New York
ZIP/Postal Code
10016-2772
Country
United States
Facility Name
Ohio State University - Wexner Medical Center /ID# 211636
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1229
Country
United States
Facility Name
STAT Research, Inc. /ID# 211404
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Premier Rheumatology of Oklahoma /ID# 213850
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-2117
Country
United States
Facility Name
Allegheny Health Network Research Institute /ID# 211607
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Univ TN Health Sciences Ctr /ID# 212177
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Dr. Ramesh Gupta /ID# 213381
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tekton Research, Inc. /ID# 211521
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Tekton Research, Inc. /ID# 214182
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Trinity Universal Research Associates - Carrollton /ID# 211527
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Accurate Clinical Management /ID# 213571
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
West Texas Clinical Research /ID# 211529
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 211520
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Carilion Clinic /ID# 213500
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 211457
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Rheumatology and Pulmonary Clinic /ID# 211398
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
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# 211679
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
CER Instituto Medico /ID# 222757
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Aprillus Asistencia e Investigacion /ID# 211630
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto CAICI S.R.L /ID# 211633
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Tucuman /ID# 212714
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigaciones Clinicas Tucuman /ID# 211942
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Cordoba /ID# 212200
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Emeritus Research Sydney /ID# 222983
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
Royal North Shore Hospital /ID# 222982
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital /ID# 212667
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Rheumatology Research Unit Sunshine Coast /ID# 211902
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Griffith University /ID# 223543
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 211901
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Emeritus Research /ID# 211903
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Monash Medical Centre /ID# 212313
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 212311
City
Fitzroy Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
UMHAT Kaspela EOOD /ID# 223141
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 223139
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski /ID# 223140
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
St. Josephs Health Care Centre /ID# 212331
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Toronto Western Hospital /ID# 213336
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc. /ID# 217734
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Anhui Provincial Hospital /ID# 211812
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Peking Union Medical College Hospital /ID# 211614
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Guangdong Provincial People's Hospital /ID# 211811
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Xiangya Hospital Central South University /ID# 212919
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangsu Province Hospital /ID# 211818
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Huashan Hospital, Fudan University /ID# 213976
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Changhai Hospital /ID# 211819
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
People's Hospital of Xinjiang /ID# 211821
City
Urumqi
ZIP/Postal Code
830001
Country
China
Facility Name
Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
80002
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Preventive Care Sas /Id# 211896
City
Chia
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Healthy Medical Center SAS /ID# 211899
City
Zipaquira
State/Province
Cundinamarca
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Clinica Universitaria Bolivari /ID# 211897
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 211829
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Bordeaux - Hopital Pellegrin /ID# 211832
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
AP-HP - Hôpital Bicêtre /ID# 211968
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Hopital Pitie Salpetriere /ID# 211831
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Strasbourg - Hopital Civil /ID# 211981
City
Strasbourg cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Universitaetsklinikum Duesseldorf /ID# 212408
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 212042
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Chukyo Hospital /ID# 222625
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Facility Name
NHO Nagoya Medical Center /ID# 213974
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Hamanomachi Hospital /ID# 213696
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Fukushima Medical University Hospital /ID# 213913
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 213846
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Tomakomai City Hospital /ID# 214234
City
Tomakomai-shi
State/Province
Hokkaido
ZIP/Postal Code
053-0034
Country
Japan
Facility Name
Kita-harima Medical Center /ID# 215474
City
Ono-shi
State/Province
Hyogo
ZIP/Postal Code
675-1327
Country
Japan
Facility Name
EIRAKU Internal Medicine Clinic /ID# 215419
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Facility Name
Yokohama Rosai Hospital /ID# 213690
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Kumamoto Shinto General Hospital /ID# 215347
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Tohoku University Hospital /ID# 213693
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Shinshu University Hospital /ID# 213853
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Nagano Red Cross Hospital /ID# 214572
City
Nagano-shi
State/Province
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Facility Name
Saitama Medical Center /ID# 213687
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Keio University Hospital /ID# 216347
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Ajou University Hospital /ID# 211692
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
KonKuk University Medical Center /ID# 213410
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 211695
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 211691
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 211740
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
RM Pharma Specialists S.A de C.V. /ID# 211879
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# 211875
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 212946
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral en Reumatologia S.A de C.V /ID# 211876
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
City
San Luis Potosí
State/Province
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Medical Care & Research SA de CV /ID# 212682
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Vrije Universiteit Medisch Centrum /ID# 214424
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum /ID# 214413
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 214415
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Middlemore Clinical Trials /ID# 213504
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
North Shore Hospital /ID# 213506
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Waikato Hospital /ID# 213505
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa /ID# 218176
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-545
Country
Poland
Facility Name
GCM Medical Group PSC /ID# 211251
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 213384
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
HUA - Txagorritxu /ID# 212520
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 212722
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario de Galdakao /ID# 212803
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 211719
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 211757
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme /ID# 212721
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 211720
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
China Medical University Hospital /ID# 212179
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 211957
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 211752
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Medical University Hospital /ID# 221600
City
Taipei City
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 212216
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 211751
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 211931
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 213189
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 211838
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/
Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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)

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