- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978520
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Cordoba, Argentina, 5000
- Hospital Cordoba /ID# 212200
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Buenos Aires
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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1426
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685
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La Plata, Buenos Aires, Argentina, 1900
- Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679
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Quilmes, Buenos Aires, Argentina, 1878
- CER Instituto Medico /ID# 222757
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Ciuadad Autonoma De Buenos Aires
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Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1046
- Aprillus Asistencia e Investigacion /ID# 211630
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634
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Rosario, Santa Fe, Argentina, 2000
- Instituto CAICI S.R.L /ID# 211633
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina, 4000
- Centro de Investigaciones Medicas Tucuman /ID# 212714
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San Miguel de Tucuman, Tucuman, Argentina, 4000
- Investigaciones Clinicas Tucuman /ID# 211942
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New South Wales
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Botany, New South Wales, Australia, 2019
- Emeritus Research Sydney /ID# 222983
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital /ID# 222982
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital /ID# 212667
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Maroochydore, Queensland, Australia, 4558
- Rheumatology Research Unit Sunshine Coast /ID# 211902
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Southport, Queensland, Australia, 4222
- Griffith University /ID# 223543
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South Australia
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Woodville South, South Australia, Australia, 5011
- The Queen Elizabeth Hospital /ID# 211901
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research /ID# 211903
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre /ID# 212313
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Fitzroy Melbourne, Victoria, Australia, 3065
- St Vincent's Hospital Melbourne /ID# 212311
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Plovdiv, Bulgaria, 4001
- UMHAT Kaspela EOOD /ID# 223141
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Sofia, Bulgaria, 1431
- UMHAT Sveti Ivan Rilski /ID# 223139
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Sofia, Bulgaria, 1431
- UMHAT Sveti Ivan Rilski /ID# 223140
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662
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London, Ontario, Canada, N6A 4V2
- St. Josephs Health Care Centre /ID# 212331
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital /ID# 213336
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Quebec
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Sherbrooke, Quebec, Canada, J1L 0H8
- Diex Recherche Sherbrooke Inc. /ID# 217734
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Urumqi, China, 830001
- People's Hospital of Xinjiang /ID# 211821
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Anhui
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Hefei, Anhui, China, 230001
- Anhui Provincial Hospital /ID# 211812
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Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital /ID# 211614
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital /ID# 211811
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Hunan
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Changsha, Hunan, China, 410008
- Xiangya Hospital Central South University /ID# 212919
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital /ID# 211818
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Shanghai
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Shanghai, Shanghai, China, 200040
- Huashan Hospital, Fudan University /ID# 213976
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Shanghai, Shanghai, China, 200433
- Shanghai Changhai Hospital /ID# 211819
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Medellin, Colombia, 050034
- Clinica Universitaria Bolivari /ID# 211897
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Atlantico
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Barranquilla, Atlantico, Colombia, 80002
- Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110221
- Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895
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Chia, Cundinamarca, Colombia, 250001
- Preventive Care Sas /Id# 211896
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Zipaquira, Cundinamarca, Colombia, 250252
- Healthy Medical Center SAS /ID# 211899
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Bordeaux, France, 33000
- CHU Bordeaux - Hopital Pellegrin /ID# 211832
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Le Kremlin Bicetre, France, 94270
- AP-HP - Hôpital Bicêtre /ID# 211968
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Paris, France, 75013
- Hopital Pitie Salpetriere /ID# 211831
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Strasbourg cedex, France, 67091
- CHU Strasbourg - Hopital Civil /ID# 211981
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Hauts-de-France
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Lille, Hauts-de-France, France, 59037
- CHRU Lille - Hopital Claude Huriez /ID# 211829
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Berlin, Germany, 10117
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988
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Dresden, Germany, 01307
- Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770
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Nordrhein-Westfalen
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Düsseldorf, Nordrhein-Westfalen, Germany, 40225
- Universitaetsklinikum Duesseldorf /ID# 212408
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674
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Budapest, Hungary, 1023
- Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827
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Gyula, Hungary, 5700
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971
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Hajdu-Bihar
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Debrecen, Hajdu-Bihar, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont /ID# 212042
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Veszprem
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Veszprém, Veszprem, Hungary, 8200
- Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796
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Milan, Italy, 20122
- ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063
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Udine, Italy, 33100
- Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858
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Ferrara
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Cona, Ferrara, Italy, 44124
- Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861
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Lazio
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Rome, Lazio, Italy, 00161
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195
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Aichi
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Nagoya-shi, Aichi, Japan, 457-8510
- Chukyo Hospital /ID# 222625
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Nagoya-shi, Aichi, Japan, 460-0001
- NHO Nagoya Medical Center /ID# 213974
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 810-8539
- Hamanomachi Hospital /ID# 213696
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Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548
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Fukushima
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Fukushima-shi, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital /ID# 213913
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694
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Hokkaido
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Asahikawa-shi, Hokkaido, Japan, 070-8644
- National Hospital Organization Asahikawa Medical Center /ID# 213846
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Tomakomai-shi, Hokkaido, Japan, 053-0034
- Tomakomai City Hospital /ID# 214234
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Hyogo
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Ono-shi, Hyogo, Japan, 675-1327
- Kita-harima Medical Center /ID# 215474
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 890-0063
- EIRAKU Internal Medicine Clinic /ID# 215419
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 222-0036
- Yokohama Rosai Hospital /ID# 213690
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan, 862-8655
- Kumamoto Shinto General Hospital /ID# 215347
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Miyagi
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Sendai-shi, Miyagi, Japan, 9808574
- Tohoku University Hospital /ID# 213693
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Nagano
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Matsumoto-shi, Nagano, Japan, 390-8621
- Shinshu University Hospital /ID# 213853
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Nagano-shi, Nagano, Japan, 380-8582
- Nagano Red Cross Hospital /ID# 214572
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Saitama
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Kawagoe-shi, Saitama, Japan, 350-8550
- Saitama Medical Center /ID# 213687
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University Hospital /ID# 216347
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Gwangju, Korea, Republic of, 61469
- Chonnam National University Hospital /ID# 211695
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Incheon, Korea, Republic of, 22332
- Inha University Hospital /ID# 211691
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital /ID# 211740
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Gyeonggido
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Suwon, Gyeonggido, Korea, Republic of, 16499
- Ajou University Hospital /ID# 211692
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
- KonKuk University Medical Center /ID# 213410
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Ciudad De Mexico
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Mexico City, Ciudad De Mexico, Mexico, 03100
- RM Pharma Specialists S.A de C.V. /ID# 211879
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Mexico City, Ciudad De Mexico, Mexico, 11850
- CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875
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Guanajuato
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Leon, Guanajuato, Mexico, 37000
- Morales Vargas Centro de Investigacion S.C. /ID# 212946
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- Centro Integral en Reumatologia S.A de C.V /ID# 211876
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532
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San Luis Potosi
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San Luis Potosí, San Luis Potosi, Mexico, 78213
- Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737
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Yucatan
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Mérida, Yucatan, Mexico, 97070
- Medical Care & Research SA de CV /ID# 212682
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Amsterdam, Netherlands, 1081 HV
- Vrije Universiteit Medisch Centrum /ID# 214424
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Leiden, Netherlands, 2333 ZA
- Leids Universitair Medisch Centrum /ID# 214413
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Utrecht, Netherlands, 3584 CX
- Universitair Medisch Centrum Utrecht /ID# 214415
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Auckland
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Papatoetoe, Auckland, New Zealand, 2025
- Middlemore Clinical Trials /ID# 213504
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Takapuna, Auckland, New Zealand, 0622
- North Shore Hospital /ID# 213506
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Waikato
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Hamilton, Waikato, New Zealand, 3240
- Waikato Hospital /ID# 213505
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Dolnoslaskie
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Wroclaw, Dolnoslaskie, Poland, 51-685
- WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482
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Malopolskie
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Krakow, Malopolskie, Poland, 31-011
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146
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Mazowieckie
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Warsaw, Mazowieckie, Poland, 01-868
- Centrum Medyczne Pratia Warszawa /ID# 218176
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Wielkopolskie
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Poznan, Wielkopolskie, Poland, 61-545
- Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483
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San Juan, Puerto Rico, 00917-3104
- GCM Medical Group PSC /ID# 211251
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San Juan, Puerto Rico, 00918-3756
- Mindful Medical Research /ID# 213384
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A Coruna, Spain, 15006
- Hospital Universitario A Coruna - CHUAC /ID# 211719
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre /ID# 211757
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Sevilla, Spain, 41014
- Hospital Universitario Virgen de Valme /ID# 212721
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Valencia, Spain, 46026
- Hospital Universitario y Politecnico La Fe /ID# 211720
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Alava
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Vitoria, Alava, Spain, 01009
- HUA - Txagorritxu /ID# 212520
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Barcelona
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Sabadell, Barcelona, Spain, 08208
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- Hospital Universitario Basurto /ID# 212722
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Galdakao, Vizcaya, Spain, 48960
- Hospital Universitario de Galdakao /ID# 212803
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital /ID# 211957
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Taichung City, Taiwan, 40447
- China Medical University Hospital /ID# 212179
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Taipei City, Taiwan, 100
- National Taiwan University Hospital /ID# 211752
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Taipei City, Taiwan, 11031
- Taipei Medical University Hospital /ID# 221600
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Taipei City, Taiwan, 11217
- Taipei Veterans General Hosp /ID# 212216
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Taoyuan City, Taiwan, 333
- Linkou Chang Gung Memorial Hospital /ID# 211751
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Cambridge, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust /ID# 213189
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Manchester, United Kingdom, M13 9WL
- Manchester University NHS Foundation Trust /ID# 211838
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London, City Of
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London, London, City Of, United Kingdom, SE1 9RT
- Guys and St Thomas NHS Foundation Trust /ID# 211931
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Arizona
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Mesa, Arizona, United States, 85210-6871
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522
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Phoenix, Arizona, United States, 85032-9306
- AZ Arthritis and Rheumotology Research, PLLC /ID# 211329
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Phoenix, Arizona, United States, 85032-9306
- AZ Arthritis and Rheumotology Research, PLLC /ID# 214267
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Arkansas
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Jonesboro, Arkansas, United States, 72401-6251
- Arthritis and Rheumatism Associates /ID# 211411
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California
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Beverly Hills, California, United States, 90211
- Wallace Rheumatic Studies Center, LLC /ID# 211600
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La Palma, California, United States, 90623-1728
- Arthritis & Osteo Medical Ctr /ID# 228235
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Los Alamitos, California, United States, 90720-5402
- Valerius Medical Group & Research Center /ID# 211599
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San Leandro, California, United States, 94578
- East Bay Rheumatology Medical /ID# 211638
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Torrance, California, United States, 90502
- The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402
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Tujunga, California, United States, 91042-2706
- Medvin Clinical Research /ID# 211996
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Upland, California, United States, 91786
- Inland Rheum Clin Trials Inc. /ID# 213617
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital /ID# 211314
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University /ID# 212824
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Medstar Health Research Institute /ID# 213335
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Florida
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Aventura, Florida, United States, 33180
- Arthritis & Rheumatic Disease Specialties /ID# 214052
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Miami, Florida, United States, 33126
- LeJenue Research Associates /ID# 212327
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Miami, Florida, United States, 33173
- Ctr Arthritis & Rheumatic Dise /ID# 212326
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Ormond Beach, Florida, United States, 32174
- Millennium Research /ID# 219099
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Plantation, Florida, United States, 33324
- IRIS Research and Development, LLC /ID# 213053
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Tamarac, Florida, United States, 33321
- West Broward Rheumatology Associates /ID# 211881
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Tampa, Florida, United States, 33614-7101
- BayCare Medical Group, Inc. /ID# 218818
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Illinois
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Oak Brook, Illinois, United States, 60523-1245
- Affinity Clinical Research /ID# 211496
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Vernon Hills, Illinois, United States, 60061
- Deerbrook Medical Associates /ID# 212251
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Indiana
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Evansville, Indiana, United States, 47714-0805
- Qualmedica Research, LLC /ID# 214765
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics /ID# 215246
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Maryland
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Wheaton, Maryland, United States, 20902
- The Center for Rheumatology and Bone Research /ID# 211610
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Massachusetts
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Boston, Massachusetts, United States, 02215-5400
- Beth Israel Deaconess Medical Center /ID# 212321
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System /ID# 211676
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Lansing, Michigan, United States, 48910
- June DO, PC /ID# 211674
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Missouri
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Saint Louis, Missouri, United States, 63131-1703
- West County Rheumatology /ID# 225051
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New York
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Brooklyn, New York, United States, 11201
- NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548
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New York, New York, United States, 10016-2772
- NYU Langone Orthopedic Center /ID# 213620
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Ohio
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Columbus, Ohio, United States, 43210-1229
- Ohio State University - Wexner Medical Center /ID# 211636
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Vandalia, Ohio, United States, 45377-9464
- STAT Research, Inc. /ID# 211404
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Oklahoma
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Tulsa, Oklahoma, United States, 74136-2117
- Premier Rheumatology of Oklahoma /ID# 213850
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Allegheny Health Network Research Institute /ID# 211607
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Tennessee
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Memphis, Tennessee, United States, 38103
- Univ TN Health Sciences Ctr /ID# 212177
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Memphis, Tennessee, United States, 38119
- Dr. Ramesh Gupta /ID# 213381
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Texas
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Austin, Texas, United States, 78745
- Tekton Research, Inc. /ID# 211521
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Austin, Texas, United States, 78745
- Tekton Research, Inc. /ID# 214182
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Carrollton, Texas, United States, 75007
- Trinity Universal Research Associates - Carrollton /ID# 211527
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Houston, Texas, United States, 77084
- Accurate Clinical Management /ID# 213571
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Lubbock, Texas, United States, 79424
- West Texas Clinical Research /ID# 211529
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Mesquite, Texas, United States, 75150
- SW Rheumatology Res. LLC /ID# 211520
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Virginia
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Roanoke, Virginia, United States, 24016
- Carilion Clinic /ID# 213500
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center /ID# 211457
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West Virginia
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Beckley, West Virginia, United States, 25801
- Rheumatology and Pulmonary Clinic /ID# 211398
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Elsubrutinib placebo/upadacitinib placebo
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
|
Capsule; Oral
Film-coated tablet; Oral
|
Experimental: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)
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
|
Capsule; Oral
Other Names:
Film-coated tablet; Oral
Other Names:
|
Experimental: Elsubrutinib placebo/upadacitinib 30 mg
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
|
Capsule; Oral
Film-coated tablet; Oral
Other Names:
|
Experimental: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)
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
|
Capsule; Oral
Other Names:
Film-coated tablet; Oral
Other Names:
|
Experimental: Elsubrutinib 60 mg/upadacitinib placebo
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
|
Capsule; Oral
Other Names:
Film-coated tablet; Oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
Time Frame: Baseline, Week 24
|
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:
|
Baseline, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
Time Frame: Baseline, Week 24
|
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:
|
Baseline, Week 24
|
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
Time Frame: Baseline, 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.
|
Baseline, Week 24
|
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
Time Frame: Baseline, 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).
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Baseline, Week 24
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Change From Baseline in Daily Prednisone Dose at Week 24
Time Frame: From Baseline to Week 24
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Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
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From Baseline to Week 24
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Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Time Frame: From Baseline to Week 24
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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.
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From Baseline to Week 24
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M19-130
- 2019-000638-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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