Systemic Lupus Erythematosus (SLE)Phase 2SLEekNCT03978520
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)
A Phase 2 study testing Elsubrutinib and Upadacitinib in people with Systemic Lupus Erythematosus (SLE), run by AbbVie at 160 sites in 21 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Elsubrutinib and Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 160 sitesin 21 countries
- Study dates
- 25 Jul 2019to 14 Jul 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
160 sites in 21 countries.
160 sites in 21 countries
United States47 sites
University of Colorado Hospital /ID# 211314
Aurora, Colorado, 80045
Tekton Research, Inc. /ID# 211521
Austin, Texas, 78745
Tekton Research, Inc. /ID# 214182
Austin, Texas, 78745
Arthritis & Rheumatic Disease Specialties /ID# 214052
Aventura, Florida, 33180
Rheumatology and Pulmonary Clinic /ID# 211398
Beckley, West Virginia, 25801
Wallace Rheumatic Studies Center, LLC /ID# 211600
Beverly Hills, California, 90211
Beth Israel Deaconess Medical Center /ID# 212321
Boston, Massachusetts, 02215-5400
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
Brooklyn, New York, 11201
Trinity Universal Research Associates - Carrollton /ID# 211527
Carrollton, Texas, 75007
Ohio State University - Wexner Medical Center /ID# 211636
Columbus, Ohio, 43210-1229
Henry Ford Health System /ID# 211676
Detroit, Michigan, 48202
Qualmedica Research, LLC /ID# 214765
Evansville, Indiana, 47714-0805
Accurate Clinical Management /ID# 213571
Houston, Texas, 77084
University of Iowa Hospitals and Clinics /ID# 215246
Iowa City, Iowa, 52242
Arthritis and Rheumatism Associates /ID# 211411
Jonesboro, Arkansas, 72401-6251
Arthritis & Osteo Medical Ctr /ID# 228235
La Palma, California, 90623-1728
June DO, PC /ID# 211674
Lansing, Michigan, 48910
Valerius Medical Group & Research Center /ID# 211599
Los Alamitos, California, 90720-5402
West Texas Clinical Research /ID# 211529
Lubbock, Texas, 79424
Univ TN Health Sciences Ctr /ID# 212177
Memphis, Tennessee, 38103
Dr. Ramesh Gupta /ID# 213381
Memphis, Tennessee, 38119
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
Mesa, Arizona, 85210-6871
SW Rheumatology Res. LLC /ID# 211520
Mesquite, Texas, 75150
LeJenue Research Associates /ID# 212327
Miami, Florida, 33126
Ctr Arthritis & Rheumatic Dise /ID# 212326
Miami, Florida, 33173
Yale University /ID# 212824
New Haven, Connecticut, 06510
NYU Langone Orthopedic Center /ID# 213620
New York, New York, 10016-2772
Affinity Clinical Research /ID# 211496
Oak Brook, Illinois, 60523-1245
Millennium Research /ID# 219099
Ormond Beach, Florida, 32174
AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
Phoenix, Arizona, 85032-9306
AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
Phoenix, Arizona, 85032-9306
Allegheny Health Network Research Institute /ID# 211607
Pittsburgh, Pennsylvania, 15224
IRIS Research and Development, LLC /ID# 213053
Plantation, Florida, 33324
Carilion Clinic /ID# 213500
Roanoke, Virginia, 24016
East Bay Rheumatology Medical /ID# 211638
San Leandro, California, 94578
Virginia Mason Medical Center /ID# 211457
Seattle, Washington, 98101
West County Rheumatology /ID# 225051
St Louis, Missouri, 63131-1703
West Broward Rheumatology Associates /ID# 211881
Tamarac, Florida, 33321
BayCare Medical Group, Inc. /ID# 218818
Tampa, Florida, 33614-7101
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
Torrance, California, 90502
Medvin Clinical Research /ID# 211996
Tujunga, California, 91042-2706
Premier Rheumatology of Oklahoma /ID# 213850
Tulsa, Oklahoma, 74136-2117
Inland Rheum Clin Trials Inc. /ID# 213617
Upland, California, 91786
STAT Research, Inc. /ID# 211404
Vandalia, Ohio, 45377-9464
Deerbrook Medical Associates /ID# 212251
Vernon Hills, Illinois, 60061
Medstar Health Research Institute /ID# 213335
Washington D.C., District of Columbia, 20010
The Center for Rheumatology and Bone Research /ID# 211610
Wheaton, Maryland, 20902
Japan17 sites
National Hospital Organization Asahikawa Medical Center /ID# 213846
Asahikawa-shi, Hokkaido, 070-8644
Hamanomachi Hospital /ID# 213696
Fukuoka, Fukuoka, 810-8539
Fukushima Medical University Hospital /ID# 213913
Fukushima, Fukushima, 960-1295
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
Hiroshima, Hiroshima, 730-8619
EIRAKU Internal Medicine Clinic /ID# 215419
Kagoshima, Kagoshima-ken, 890-0063
Saitama Medical Center /ID# 213687
Kawagoe-shi, Saitama, 350-8550
Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
Kitakyushu-shi, Fukuoka, 807-8556
Kumamoto Shinto General Hospital /ID# 215347
Kumamoto, Kumamoto, 862-8655
Shinshu University Hospital /ID# 213853
Matsumoto-shi, Nagano, 390-8621
Nagano Red Cross Hospital /ID# 214572
Nagano, Nagano, 380-8582
Chukyo Hospital /ID# 222625
Nagoya, Aichi-ken, 457-8510
NHO Nagoya Medical Center /ID# 213974
Nagoya, Aichi-ken, 460-0001
Kita-harima Medical Center /ID# 215474
Ono-shi, Hyōgo, 675-1327
Tohoku University Hospital /ID# 213693
Sendai, Miyagi, 9808574
Keio University Hospital /ID# 216347
Shinjuku-ku, Tokyo, 160-8582
Tomakomai City Hospital /ID# 214234
Tomakomai-shi, Hokkaido, 053-0034
Yokohama Rosai Hospital /ID# 213690
Yokohama, Kanagawa, 222-0036
Argentina9 sites
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
Ciudad Autonoma Buenos Aires, Buenos Aires, 1426
Aprillus Asistencia e Investigacion /ID# 211630
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1046
Hospital Cordoba /ID# 212200
Córdoba, 5000
Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
La Plata, Buenos Aires, 1900
CER Instituto Medico /ID# 222757
Quilmes, Buenos Aires, 1878
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
Rosario, Santa Fe Province, 2000
Instituto CAICI S.R.L /ID# 211633
Rosario, Santa Fe Province, 2000
Centro de Investigaciones Medicas Tucuman /ID# 212714
San Miguel de Tucumán, Tucumán Province, 4000
Investigaciones Clinicas Tucuman /ID# 211942
San Miguel de Tucumán, Tucumán Province, 4000
Australia9 sites
Emeritus Research Sydney /ID# 222983
Botany, New South Wales, 2019
Emeritus Research /ID# 211903
Camberwell, Victoria, 3124
Monash Medical Centre /ID# 212313
Clayton, Victoria, 3168
St Vincent's Hospital Melbourne /ID# 212311
Fitzroy Melbourne, Victoria, 3065
Royal Brisbane and Women's Hospital /ID# 212667
Herston, Queensland, 4029
Rheumatology Research Unit Sunshine Coast /ID# 211902
Maroochydore, Queensland, 4558
Griffith University /ID# 223543
Southport, Queensland, 4222
Royal North Shore Hospital /ID# 222982
St Leonards, New South Wales, 2065
The Queen Elizabeth Hospital /ID# 211901
Woodville South, South Australia, 5011
China8 sites
Peking Union Medical College Hospital /ID# 211614
Beijing, Beijing Municipality, 100730
Xiangya Hospital Central South University /ID# 212919
Changsha, Hunan, 410008
Guangdong Provincial People's Hospital /ID# 211811
Guangzhou, Guangdong, 510080
Anhui Provincial Hospital /ID# 211812
Hefei, Anhui, 230001
Jiangsu Province Hospital /ID# 211818
Nanjing, Jiangsu, 210029
Huashan Hospital, Fudan University /ID# 213976
Shanghai, Shanghai Municipality, 200040
Shanghai Changhai Hospital /ID# 211819
Shanghai, Shanghai Municipality, 200433
People's Hospital of Xinjiang /ID# 211821
Ürümqi, 830001
Spain8 sites
Hospital Universitario A Coruna - CHUAC /ID# 211719
A Coruña, 15006
Hospital Universitario Basurto /ID# 212722
Bilbao, Vizcaya, 48013
Hospital Universitario de Galdakao /ID# 212803
Galdakao, Vizcaya, 48960
Hospital Universitario 12 de Octubre /ID# 211757
Madrid, 28041
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
Sabadell, Barcelona, 08208
Hospital Universitario Virgen de Valme /ID# 212721
Seville, 41014
Hospital Universitario y Politecnico La Fe /ID# 211720
Valencia, 46026
HUA - Txagorritxu /ID# 212520
Vitoria-Gasteiz, Alava, 01009
Mexico7 sites
Centro Integral en Reumatologia S.A de C.V /ID# 211876
Guadalajara, Jalisco, 44160
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
Guadalajara, Jalisco, 44690
Morales Vargas Centro de Investigacion S.C. /ID# 212946
León, Guanajuato, 37000
Medical Care & Research SA de CV /ID# 212682
Mérida, Yucatán, 97070
RM Pharma Specialists S.A de C.V. /ID# 211879
Mexico City, Mexico City, 03100
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
Mexico City, Mexico City, 11850
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
San Luis Potosí City, San Luis Potosí, 78213
Taiwan6 sites
China Medical University Hospital /ID# 212179
Taichung, 40447
Taichung Veterans General Hospital /ID# 211957
Taichung, 40705
National Taiwan University Hospital /ID# 211752
Taipei, 100
Taipei Medical University Hospital /ID# 221600
Taipei, 11031
Taipei Veterans General Hosp /ID# 212216
Taipei, 11217
Linkou Chang Gung Memorial Hospital /ID# 211751
Taoyuan City, 333
Colombia5 sites
Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
Barranquilla, Atlántico, 80002
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
Bogota, Cundinamarca, 110221
Preventive Care Sas /Id# 211896
Chía, Cundinamarca, 250001
Clinica Universitaria Bolivari /ID# 211897
Medellín, 050034
Healthy Medical Center SAS /ID# 211899
Zipaquirá, Cundinamarca, 250252
France5 sites
CHU Bordeaux - Hopital Pellegrin /ID# 211832
Bordeaux, 33000
AP-HP - Hôpital Bicêtre /ID# 211968
Le Kremlin-Bicêtre, 94270
CHRU Lille - Hopital Claude Huriez /ID# 211829
Lille, Hauts-de-France, 59037
Hopital Pitie Salpetriere /ID# 211831
Paris, 75013
CHU Strasbourg - Hopital Civil /ID# 211981
Strasbourg, 67091
South Korea5 sites
Chonnam National University Hospital /ID# 211695
Gwangju, 61469
Inha University Hospital /ID# 211691
Incheon, 22332
KonKuk University Medical Center /ID# 213410
Seoul, Seoul Teugbyeolsi, 05030
Seoul National University Hospital /ID# 211740
Seoul, 03080
Ajou University Hospital /ID# 211692
Suwon, Gyeonggido, 16499
Canada4 sites
Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
Hamilton, Ontario, L8S 4K1
St. Josephs Health Care Centre /ID# 212331
London, Ontario, N6A 4V2
Diex Recherche Sherbrooke Inc. /ID# 217734
Sherbrooke, Quebec, J1L 0H8
Toronto Western Hospital /ID# 213336
Toronto, Ontario, M5T 2S8
Germany4 sites
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
Berlin, 10117
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
Dresden, 01307
Universitaetsklinikum Duesseldorf /ID# 212408
Düsseldorf, North Rhine-Westphalia, 40225
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
Kiel, Schleswig-Holstein, 24105
Hungary4 sites
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
Budapest, 1023
Debreceni Egyetem Klinikai Kozpont /ID# 212042
Debrecen, Hajdú-Bihar, 4032
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
Gyula, 5700
Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
Veszprém, Veszprém megye, 8200
Italy4 sites
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
Cona, Ferrara, 44124
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
Milan, 20122
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
Rome, Lazio, 00161
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
Udine, 33100
Poland4 sites
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
Krakow, Lesser Poland Voivodeship, 31-011
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
Poznan, Greater Poland Voivodeship, 61-545
Centrum Medyczne Pratia Warszawa /ID# 218176
Warsaw, Masovian Voivodeship, 01-868
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
Wroclaw, Lower Silesian Voivodeship, 51-685
Bulgaria3 sites
UMHAT Kaspela EOOD /ID# 223141
Plovdiv, 4001
UMHAT Sveti Ivan Rilski /ID# 223139
Sofia, 1431
UMHAT Sveti Ivan Rilski /ID# 223140
Sofia, 1431
Netherlands3 sites
Vrije Universiteit Medisch Centrum /ID# 214424
Amsterdam, 1081 HV
Leids Universitair Medisch Centrum /ID# 214413
Leiden, 2333 ZA
Universitair Medisch Centrum Utrecht /ID# 214415
Utrecht, 3584 CX
New Zealand3 sites
Waikato Hospital /ID# 213505
Hamilton, Waikato Region, 3240
Middlemore Clinical Trials /ID# 213504
Papatoetoe, Auckland, 2025
North Shore Hospital /ID# 213506
Takapuna, Auckland, 0622
United Kingdom3 sites
Cambridge University Hospitals NHS Foundation Trust /ID# 213189
Cambridge, CB2 0QQ
Guys and St Thomas NHS Foundation Trust /ID# 211931
London, London, City of, SE1 9RT
Manchester University NHS Foundation Trust /ID# 211838
Manchester, M13 9WL
Puerto Rico2 sites
GCM Medical Group PSC /ID# 211251
San Juan, 00917-3104
Mindful Medical Research /ID# 213384
San Juan, 00918-3756
About this study
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
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.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Elsubrutinib, Placebo for elsubrutinib, Upadacitinib, Placebo for upadacitinib
- Keywords
- Systemic Lupus Erythematosus (SLE), ABBV-105, Upadacitinib, ABBV-599, Elsubrutinib
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElsubrutinibDrug
Also called ABBV-105
Capsule; Oral
Placebo for elsubrutinibDrug
Capsule; Oral
UpadacitinibDrug
Also called RINVOQ
Film-coated tablet; Oral
Placebo for upadacitinibDrug
Film-coated tablet; Oral
| Study group | Role | What they receive |
|---|---|---|
| Elsubrutinib placebo/upadacitinib placebo | Placebo comparator | 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 Receives: Drug: Placebo for elsubrutinib; Drug: Placebo for upadacitinib |
| ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) | Experimental | 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 Receives: Drug: Elsubrutinib; Drug: Upadacitinib |
| Elsubrutinib placebo/upadacitinib 30 mg | Experimental | 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 Receives: Drug: Placebo for elsubrutinib; Drug: Upadacitinib |
| ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) | Experimental | 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 Receives: Drug: Elsubrutinib; Drug: Upadacitinib |
| Elsubrutinib 60 mg/upadacitinib placebo | Experimental | 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 Receives: Drug: Elsubrutinib; Drug: Placebo for upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (5)
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.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
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).
Measured: Baseline, Week 24
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.
Measured: 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
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.
Measured: From Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start25 Jul 2019
- Primary completion19 Jan 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978520
- Sponsor's protocol ID
- M19-130
- Other IDs
- 2019-000638-20, 2019
- Acronym
- SLEek
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2019
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33687069