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
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
2 other identifiers
interventional
341
21 countries
160
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.
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 2019
Typical duration for phase_2
160 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 3, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2022
CompletedResults Posted
Study results publicly available
July 21, 2023
CompletedJuly 21, 2023
June 1, 2023
2.5 years
June 3, 2019
June 27, 2023
June 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 24
Secondary Outcomes (5)
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
Baseline, Week 24
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
Baseline, Week 24
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
Baseline, Week 24
Change From Baseline in Daily Prednisone Dose at Week 24
From Baseline to Week 24
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
From Baseline to Week 24
Study Arms (5)
Elsubrutinib placebo/upadacitinib placebo
PLACEBO COMPARATORPlacebo 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
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)
EXPERIMENTAL60 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
Elsubrutinib placebo/upadacitinib 30 mg
EXPERIMENTALPlacebo 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
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)
EXPERIMENTAL60 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
Elsubrutinib 60 mg/upadacitinib placebo
EXPERIMENTAL60 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
Interventions
Capsule; Oral
Capsule; Oral
Film-coated tablet; Oral
Film-coated tablet; Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (160)
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
Mesa, Arizona, 85210-6871, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
Phoenix, Arizona, 85032-9306, United States
Arthritis and Rheumatism Associates /ID# 211411
Jonesboro, Arkansas, 72401-6251, United States
Wallace Rheumatic Studies Center, LLC /ID# 211600
Beverly Hills, California, 90211, United States
Arthritis & Osteo Medical Ctr /ID# 228235
La Palma, California, 90623-1728, United States
Valerius Medical Group & Research Center /ID# 211599
Los Alamitos, California, 90720-5402, United States
East Bay Rheumatology Medical /ID# 211638
San Leandro, California, 94578, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
Torrance, California, 90502, United States
Medvin Clinical Research /ID# 211996
Tujunga, California, 91042-2706, United States
Inland Rheum Clin Trials Inc. /ID# 213617
Upland, California, 91786, United States
University of Colorado Hospital /ID# 211314
Aurora, Colorado, 80045, United States
Yale University /ID# 212824
New Haven, Connecticut, 06510, United States
Medstar Health Research Institute /ID# 213335
Washington D.C., District of Columbia, 20010, United States
Arthritis & Rheumatic Disease Specialties /ID# 214052
Aventura, Florida, 33180, United States
LeJenue Research Associates /ID# 212327
Miami, Florida, 33126, United States
Ctr Arthritis & Rheumatic Dise /ID# 212326
Miami, Florida, 33173, United States
Millennium Research /ID# 219099
Ormond Beach, Florida, 32174, United States
IRIS Research and Development, LLC /ID# 213053
Plantation, Florida, 33324, United States
West Broward Rheumatology Associates /ID# 211881
Tamarac, Florida, 33321, United States
BayCare Medical Group, Inc. /ID# 218818
Tampa, Florida, 33614-7101, United States
Affinity Clinical Research /ID# 211496
Oak Brook, Illinois, 60523-1245, United States
Deerbrook Medical Associates /ID# 212251
Vernon Hills, Illinois, 60061, United States
Qualmedica Research, LLC /ID# 214765
Evansville, Indiana, 47714-0805, United States
University of Iowa Hospitals and Clinics /ID# 215246
Iowa City, Iowa, 52242, United States
The Center for Rheumatology and Bone Research /ID# 211610
Wheaton, Maryland, 20902, United States
Beth Israel Deaconess Medical Center /ID# 212321
Boston, Massachusetts, 02215-5400, United States
Henry Ford Health System /ID# 211676
Detroit, Michigan, 48202, United States
June DO, PC /ID# 211674
Lansing, Michigan, 48910, United States
West County Rheumatology /ID# 225051
St Louis, Missouri, 63131-1703, United States
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
Brooklyn, New York, 11201, United States
NYU Langone Orthopedic Center /ID# 213620
New York, New York, 10016-2772, United States
Ohio State University - Wexner Medical Center /ID# 211636
Columbus, Ohio, 43210-1229, United States
STAT Research, Inc. /ID# 211404
Vandalia, Ohio, 45377-9464, United States
Premier Rheumatology of Oklahoma /ID# 213850
Tulsa, Oklahoma, 74136-2117, United States
Allegheny Health Network Research Institute /ID# 211607
Pittsburgh, Pennsylvania, 15224, United States
Univ TN Health Sciences Ctr /ID# 212177
Memphis, Tennessee, 38103, United States
Dr. Ramesh Gupta /ID# 213381
Memphis, Tennessee, 38119, United States
Tekton Research, Inc. /ID# 211521
Austin, Texas, 78745, United States
Tekton Research, Inc. /ID# 214182
Austin, Texas, 78745, United States
Trinity Universal Research Associates - Carrollton /ID# 211527
Carrollton, Texas, 75007, United States
Accurate Clinical Management /ID# 213571
Houston, Texas, 77084, United States
West Texas Clinical Research /ID# 211529
Lubbock, Texas, 79424, United States
SW Rheumatology Res. LLC /ID# 211520
Mesquite, Texas, 75150, United States
Carilion Clinic /ID# 213500
Roanoke, Virginia, 24016, United States
Virginia Mason Medical Center /ID# 211457
Seattle, Washington, 98101, United States
Rheumatology and Pulmonary Clinic /ID# 211398
Beckley, West Virginia, 25801, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
Ciudad Autonoma Buenos Aires, Buenos Aires, 1426, Argentina
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
La Plata, Buenos Aires, 1900, Argentina
CER Instituto Medico /ID# 222757
Quilmes, Buenos Aires, 1878, Argentina
Aprillus Asistencia e Investigacion /ID# 211630
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1046, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
Rosario, Santa Fe Province, 2000, Argentina
Instituto CAICI S.R.L /ID# 211633
Rosario, Santa Fe Province, 2000, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 212714
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigaciones Clinicas Tucuman /ID# 211942
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Cordoba /ID# 212200
Córdoba, 5000, Argentina
Emeritus Research Sydney /ID# 222983
Botany, New South Wales, 2019, Australia
Royal North Shore Hospital /ID# 222982
St Leonards, New South Wales, 2065, Australia
Royal Brisbane and Women's Hospital /ID# 212667
Herston, Queensland, 4029, Australia
Rheumatology Research Unit Sunshine Coast /ID# 211902
Maroochydore, Queensland, 4558, Australia
Griffith University /ID# 223543
Southport, Queensland, 4222, Australia
The Queen Elizabeth Hospital /ID# 211901
Woodville South, South Australia, 5011, Australia
Emeritus Research /ID# 211903
Camberwell, Victoria, 3124, Australia
Monash Medical Centre /ID# 212313
Clayton, Victoria, 3168, Australia
St Vincent's Hospital Melbourne /ID# 212311
Fitzroy Melbourne, Victoria, 3065, Australia
UMHAT Kaspela EOOD /ID# 223141
Plovdiv, 4001, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223139
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 223140
Sofia, 1431, Bulgaria
Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
Hamilton, Ontario, L8S 4K1, Canada
St. Josephs Health Care Centre /ID# 212331
London, Ontario, N6A 4V2, Canada
Toronto Western Hospital /ID# 213336
Toronto, Ontario, M5T 2S8, Canada
Diex Recherche Sherbrooke Inc. /ID# 217734
Sherbrooke, Quebec, J1L 0H8, Canada
Anhui Provincial Hospital /ID# 211812
Hefei, Anhui, 230001, China
Peking Union Medical College Hospital /ID# 211614
Beijing, Beijing Municipality, 100730, China
Guangdong Provincial People's Hospital /ID# 211811
Guangzhou, Guangdong, 510080, China
Xiangya Hospital Central South University /ID# 212919
Changsha, Hunan, 410008, China
Jiangsu Province Hospital /ID# 211818
Nanjing, Jiangsu, 210029, China
Huashan Hospital, Fudan University /ID# 213976
Shanghai, Shanghai Municipality, 200040, China
Shanghai Changhai Hospital /ID# 211819
Shanghai, Shanghai Municipality, 200433, China
People's Hospital of Xinjiang /ID# 211821
Ürümqi, 830001, China
Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
Barranquilla, Atlántico, 80002, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
Bogota, Cundinamarca, 110221, Colombia
Preventive Care Sas /Id# 211896
Chía, Cundinamarca, 250001, Colombia
Healthy Medical Center SAS /ID# 211899
Zipaquirá, Cundinamarca, 250252, Colombia
Clinica Universitaria Bolivari /ID# 211897
Medellín, 050034, Colombia
CHRU Lille - Hopital Claude Huriez /ID# 211829
Lille, Hauts-de-France, 59037, France
CHU Bordeaux - Hopital Pellegrin /ID# 211832
Bordeaux, 33000, France
AP-HP - Hôpital Bicêtre /ID# 211968
Le Kremlin-Bicêtre, 94270, France
Hopital Pitie Salpetriere /ID# 211831
Paris, 75013, France
CHU Strasbourg - Hopital Civil /ID# 211981
Strasbourg, 67091, France
Universitaetsklinikum Duesseldorf /ID# 212408
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
Kiel, Schleswig-Holstein, 24105, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
Berlin, 10117, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
Dresden, 01307, Germany
Debreceni Egyetem Klinikai Kozpont /ID# 212042
Debrecen, Hajdú-Bihar, 4032, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
Veszprém, Veszprém megye, 8200, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
Budapest, 1023, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
Gyula, 5700, Hungary
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
Cona, Ferrara, 44124, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
Rome, Lazio, 00161, Italy
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
Udine, 33100, Italy
Chukyo Hospital /ID# 222625
Nagoya, Aichi-ken, 457-8510, Japan
NHO Nagoya Medical Center /ID# 213974
Nagoya, Aichi-ken, 460-0001, Japan
Hamanomachi Hospital /ID# 213696
Fukuoka, Fukuoka, 810-8539, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Fukushima Medical University Hospital /ID# 213913
Fukushima, Fukushima, 960-1295, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
Hiroshima, Hiroshima, 730-8619, Japan
National Hospital Organization Asahikawa Medical Center /ID# 213846
Asahikawa-shi, Hokkaido, 070-8644, Japan
Tomakomai City Hospital /ID# 214234
Tomakomai-shi, Hokkaido, 053-0034, Japan
Kita-harima Medical Center /ID# 215474
Ono-shi, Hyōgo, 675-1327, Japan
EIRAKU Internal Medicine Clinic /ID# 215419
Kagoshima, Kagoshima-ken, 890-0063, Japan
Yokohama Rosai Hospital /ID# 213690
Yokohama, Kanagawa, 222-0036, Japan
Kumamoto Shinto General Hospital /ID# 215347
Kumamoto, Kumamoto, 862-8655, Japan
Tohoku University Hospital /ID# 213693
Sendai, Miyagi, 9808574, Japan
Shinshu University Hospital /ID# 213853
Matsumoto-shi, Nagano, 390-8621, Japan
Nagano Red Cross Hospital /ID# 214572
Nagano, Nagano, 380-8582, Japan
Saitama Medical Center /ID# 213687
Kawagoe-shi, Saitama, 350-8550, Japan
Keio University Hospital /ID# 216347
Shinjuku-ku, Tokyo, 160-8582, Japan
Morales Vargas Centro de Investigacion S.C. /ID# 212946
León, Guanajuato, 37000, Mexico
Centro Integral en Reumatologia S.A de C.V /ID# 211876
Guadalajara, Jalisco, 44160, Mexico
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
Guadalajara, Jalisco, 44690, Mexico
RM Pharma Specialists S.A de C.V. /ID# 211879
Mexico City, Mexico City, 03100, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
Mexico City, Mexico City, 11850, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
San Luis Potosí City, San Luis Potosí, 78213, Mexico
Medical Care & Research SA de CV /ID# 212682
Mérida, Yucatán, 97070, Mexico
Vrije Universiteit Medisch Centrum /ID# 214424
Amsterdam, 1081 HV, Netherlands
Leids Universitair Medisch Centrum /ID# 214413
Leiden, 2333 ZA, Netherlands
Universitair Medisch Centrum Utrecht /ID# 214415
Utrecht, 3584 CX, Netherlands
Middlemore Clinical Trials /ID# 213504
Papatoetoe, Auckland, 2025, New Zealand
North Shore Hospital /ID# 213506
Takapuna, Auckland, 0622, New Zealand
Waikato Hospital /ID# 213505
Hamilton, Waikato Region, 3240, New Zealand
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
Poznan, Greater Poland Voivodeship, 61-545, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
Krakow, Lesser Poland Voivodeship, 31-011, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
Centrum Medyczne Pratia Warszawa /ID# 218176
Warsaw, Masovian Voivodeship, 01-868, Poland
GCM Medical Group PSC /ID# 211251
San Juan, 00917-3104, Puerto Rico
Mindful Medical Research /ID# 213384
San Juan, 00918-3756, Puerto Rico
Ajou University Hospital /ID# 211692
Suwon, Gyeonggido, 16499, South Korea
KonKuk University Medical Center /ID# 213410
Seoul, Seoul Teugbyeolsi, 05030, South Korea
Chonnam National University Hospital /ID# 211695
Gwangju, 61469, South Korea
Inha University Hospital /ID# 211691
Incheon, 22332, South Korea
Seoul National University Hospital /ID# 211740
Seoul, 03080, South Korea
HUA - Txagorritxu /ID# 212520
Vitoria-Gasteiz, Alava, 01009, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Basurto /ID# 212722
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario de Galdakao /ID# 212803
Galdakao, Vizcaya, 48960, Spain
Hospital Universitario A Coruna - CHUAC /ID# 211719
A Coruña, 15006, Spain
Hospital Universitario 12 de Octubre /ID# 211757
Madrid, 28041, Spain
Hospital Universitario Virgen de Valme /ID# 212721
Seville, 41014, Spain
Hospital Universitario y Politecnico La Fe /ID# 211720
Valencia, 46026, Spain
China Medical University Hospital /ID# 212179
Taichung, 40447, Taiwan
Taichung Veterans General Hospital /ID# 211957
Taichung, 40705, Taiwan
National Taiwan University Hospital /ID# 211752
Taipei, 100, Taiwan
Taipei Medical University Hospital /ID# 221600
Taipei, 11031, Taiwan
Taipei Veterans General Hosp /ID# 212216
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 211751
Taoyuan, 333, Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 211931
London, London, City of, SE1 9RT, United Kingdom
Cambridge University Hospitals NHS Foundation Trust /ID# 213189
Cambridge, CB2 0QQ, United Kingdom
Manchester University NHS Foundation Trust /ID# 211838
Manchester, M13 9WL, United Kingdom
Related Publications (1)
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.
PMID: 33687069DERIVED
Related Links
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 3, 2019
First Posted
June 7, 2019
Study Start
July 25, 2019
Primary Completion
January 19, 2022
Study Completion
July 14, 2022
Last Updated
July 21, 2023
Results First Posted
July 21, 2023
Record last verified: 2023-06
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.