A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Study Overview

• Status: Terminated
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Ustekinumab (approximately 6 mg/kg); Drug: Ustekinumab 90 mg; Drug: Placebo

Detailed Description

This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1025ABI
    • Fundación CENIT para la Investigación en Neurociencias
  • Buenos Aires, Argentina, C1204AAP
    • Instituto Centenario
  • Buenos Aires, Argentina, C1417EYG
    • Centro Privado de Medicina Familiar
  • Ciudad De La Plata, Argentina, B1902COS
    • Framingham Centro Medico
  • Cordoba, Argentina, X5004BAL
    • Hospital Italiano de Cordoba
  • Corrientes, Argentina, 3400
    • Hospital Escuela 'Gral. Jose F. de San Martin'
  • San Juan, Argentina, J5402DIL
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • MHAT Trimantium
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center (DCC) Aleksandrovska
  • Sofia, Bulgaria, 1709
    • Medical Centre Synexus
  • Sofia, Bulgaria, 1612
    • UMHAT St. Ivan Rilski
• Canada
  • Quebec, Canada, G1V-2L9
    • CHU de Quebec
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • University of Manitoba
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• China
  • Baotou, China, 014010
    • The First Affiliated Hospital of Baotou Medical University
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Hohhot, China, 10000
    • Affiliated Hospital of Inner Mongolia Med U
  • Shanghai, China, 200025
    • Shanghai Ruijin Hospital
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430030
    • Tongji Hospital of Tongji Medical College of Huangzhong Univ
  • Xi'an, China, 710061
    • The 1st affiliated Hospital of Xi'an Traffic University
• Colombia
  • Bogotá, Colombia, 110221
    • Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
  • Bucaramanga, Colombia
    • IPS Medicity SAS
  • Bucaramanga, Colombia
    • Servimed S.A.S
  • Chia, Colombia, 250001
    • Preventive Care Ltda
  • Medellin, Colombia, 050034
    • Clinica Universitaria Bolivariana
  • Montería, Colombia, 230002
    • Funcentra
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin (CCM)
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet
  • Leipzig, Germany, 04103
    • Rheumatology Unit
  • Mainz, Germany, 55131
    • Universitaetsmedizin Mainz
• Hungary
  • Budapest, Hungary, 1097
    • Szt, Istvan and Szt. Laszlo
  • Gyula, Hungary, 5700
    • Bekes Megyei Pandy Kalman Korhaz
  • Zalaegerszeg, Hungary, H-8900
    • Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
• Japan
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chibahigashi National Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima, Japan, 730-8619
    • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Hukuoka, Japan, 807-8555
    • Hospital of the University of Occupational and Environmental Health
  • Kawachi-Nagano, Japan, 586-8521
    • National Hospital Organization Osaka Minami Medical Center
  • Kitakyushu, Japan, 807-0856
    • Kawasaki Rheumatism and Internal Medicine Clinic
  • Meguro-ku, Japan, 153-8515
    • Toho University Medical Center, Ohashi Hospital
  • Nagasaki-shi, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagoya, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Sapporo, Japan, 060-8604
    • Sapporo City General Hospital
  • Sapporo-shi, Japan, 060-8648
    • Hokkaido University Hospital
  • Sasebo, Japan, 857-1165
    • Sasebo Chuo Hospital
  • Sendai-shi, Japan, 980-8574
    • Tohoku University Hospital
  • Shinjuku-ku, Japan, 160-8582
    • Keio University Hospital
  • Shinjuku-ku, Japan, 162-8655
    • National Center for Global Health and Medicine
  • Tokyo, Japan, 104-8560
    • St. Luke's International Hospital
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Yokohama, Japan, 245-8575
    • National Hospital Organization Yokohama Medical Center
• Korea, Republic of
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center
  • JeonJu, Korea, Republic of, 54907
    • Chonbuk National Univ Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Klaipeda, Lithuania, LT-92288
    • Klaipeda University Hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinics
  • Vilnius, Lithuania, 08406
    • Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • Bytom, Poland, 41-902
    • Nzoz Bif-Med
  • Lodz, Poland, 91-363
    • Centrum Medyczne AMED oddzial w Lodzi
  • Lublin, Poland, 20-954
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Nowa Sol, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Sonoswiec, Poland, 41-200
    • Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
  • Tychy, Poland, 43-100
    • Centrum Medyczne Pratia Tychy
  • Warszawa, Poland, 01-868
    • Centrum Medyczne Pratia Warszawa
  • Warszawa, Poland, 02-691
    • Reumatika-Centrum Reumatologii, NZOZ
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
• Portugal
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz
  • Lisboa, Portugal, 1050-034
    • Instituto Portugues De Reumatologia
  • Lisboa, Portugal, 1069-166
    • Hospital Curry Cabral-Centro Hospital Lisboa Central
  • Ponte de Lima, Portugal, 4990-041
    • ULSAM, EPE - Hospital Conde de Bertiandos
  • Vila Nova de Gaia, Portugal, 4434-502
    • C.H. de Vila Nova de Gaia/Espinho
• Russian Federation
  • Kemerovo, Russian Federation, 650070
    • LLL Medical Center Revma-Med
  • Kemerovo, Russian Federation, 650000
    • Regional Clinical Hospital for War Veterans
  • Omsk, Russian Federation, 644024
    • Clinical Diagnostic Center 'Ultramed'
  • Saint-Petersburg, Russian Federation, 194291
    • Leningrad region clinical hospital
  • St. Petersburg, Russian Federation, 197110
    • City Clinical Hospital #31
  • St.-Petersburg, Russian Federation, 191015
    • Northen-Western State Medical University n.a. I.I. Mechnikov
  • Ulyanovsk, Russian Federation, 432063
    • Ulyanovsk Regional Clinical Hospital
  • Yaroslavl, Russian Federation, 150003
    • Clinical Emergency Hospital n.a. N.V. Solovyev
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Bezanijska Kosa
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology Belgrade
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Niska Banja, Serbia, 18205
    • Institute for Treatment and Rehabilitation Niska Banja
  • Vojvodina, Serbia, 21000
    • Clinical Center of Vojvodina
• South Africa
  • Cape Town, South Africa, 7500
    • Panorama Medical Centre
  • George, South Africa, 6529
    • Excellentis Clinical trial Consultants
  • Pretoria, South Africa, 0002
    • Clinical Research Unit, University of Pretoria
  • Stellenbosch, South Africa, 7613
    • Winelands Medical Research Centre
• Spain
  • Barcelona, Spain, 8035
    • Hosp. Univ. Vall D Hebron
  • Bilbao, Spain, 48013
    • Hosp. Univ. de Basurto
  • Cordoba, Spain, 14004
    • Hosp. Reina Sofia
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Málaga, Spain, 29009
    • Hosp. Regional Univ. de Malaga
  • San Sebastián de los Reyes, Spain, 28702
    • Hosp. Univ. Infanta Sofia
  • Sevilla, Spain, 41010
    • Hosp. Infanta Luisa
  • Vigo -Pontevedra, Spain, 36214
    • Hosp. Do Meixoeiro
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kwei-san Hsiang, Taiwan, 333
    • Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10043
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10601
    • Cathay General Hospital
  • Taipei, Taiwan, 11031
    • Taipei Medical University
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital and Medical College
  • Bangkok, Thailand, 10400
    • Rajavhiti Hospital
  • Hat Yai, Thailand, 90110
    • Songklanagarind hospital
  • Muang, Thailand, 50200
    • Chiang Mai University
• Ukraine
  • Kharkiv, Ukraine, 61029
    • Mechnikov Inst, Miska bagatoprofilna likarnia #18
  • Kyiv, Ukraine, 02125
    • Kyiv City Clinical Hospital #3
  • Kyiv, Ukraine, 4107
    • Kyivska oblasna klinichna likarnia
  • Odesa, Ukraine, 65025
    • Odeska oblasna klinichna likarnia
  • Odessa, Ukraine, 65026
    • Multidisciplinary Medical Center of Odessa National Medical University
  • Vinnytsia, Ukraine, 21018
    • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
  • Vinnytsia, Ukraine, 21029
    • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Vestavia Hills, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research
    • Glendale, California, United States, 91204
      • Lugene Eye Institute
    • Hemet, California, United States, 92543
      • C.V. Mehta, MD Medical Corp.
    • La Jolla, California, United States, 92093
      • University of California at San Diego
    • Lakewood, California, United States, 90712
      • Advanced Medical Research - Lakewood
    • Loma Linda, California, United States, 92350
      • Loma Linda University
    • Loma Linda, California, United States, 92357
      • Loma Linda University Health Care
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group & Research Center
    • Los Angeles, California, United States, 90048
      • Wallace Rheumatic Study Center
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group
    • Thousand Oaks, California, United States, 91360
      • Westlake Medical Research Clinical Trials
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • UPMC Lupus Center of Excellence
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheumatic Disease Specialties
    • Brandon, Florida, United States, 33511
      • Bay Area Arthritis and Osteoporosis
    • Fort Lauderdale, Florida, United States, 33309
      • Centre for Rheumatology, Immunology and Arthritis
    • Jacksonville, Florida, United States, 32207
      • University of Florida Health Jacksonville
    • Miami, Florida, United States, 33175
      • New Horizon Research Center
    • Miami, Florida, United States, 33136-1002
      • University of Miami Miller School of Medicine
    • Orlando, Florida, United States, 32806
      • Rheumatology Associates of Central Florida, PA
    • Orlando, Florida, United States, 32810
      • Omega Research Consultants
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare - Piedmont Hospital
    • Decatur, Georgia, United States, 30033
      • DeKalb Medical Specialty Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves-Gilbert Clinic - Bowling Green
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Michigan
    • Lansing, Michigan, United States, 48910-8595
      • June DO, PC.
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St Paul Rheumatology PA
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
    • Las Vegas, Nevada, United States, 89102
      • Oklahoma Medical Research Foundation
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
  • New York
    • Lake Success, New York, United States, 10075
      • Biomedical Research Alliance Of New York
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10016
      • NYU Center for Musculoskeletal Care
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • OK Center for Arthritis Therapy & Research, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Lewis Katz School of Medicine, Temple University
    • Wexford, Pennsylvania, United States, 15090
      • Allegheny Rheumatology/Allegheny Singer Research Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Arthritis Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta
    • Nashville, Tennessee, United States, 37212-3103
      • Vanderbilt University Medical Center
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic
    • Dallas, Texas, United States, 75246
      • Arthritis Centers of Texas
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • San Antonio, Texas, United States, 78239
      • UT Health Science Center at San Antonio
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology & Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be male or female

• Has a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent:

  1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
  2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)
• Has a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith
• Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or >= 2 BILAG B scores observed during screening
• Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and signs of inflammation at screening, Week 0, or both
• Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0
• Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines
• Must be receiving stable doses of >=1 protocol-permitted standard of care SLE treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate, azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)

Exclusion Criteria:

• Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded
• Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
• Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per day
• Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections)
• Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma
• Has any condition requiring multiple courses of systemic glucocorticoids (example: uncontrolled asthma, chronic obstructive pulmonary disease)
• Has a history of major surgery within the last month
• Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
• Has previously received ustekinumab
• Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening
• Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent
• Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of study agent
• Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent
• Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent
• Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency glucocorticoids (World Health Organization criteria) are prohibited

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ustekinumab; Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.	Drug: Ustekinumab (approximately 6 mg/kg); Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.; Other Names: Stelara; Drug: Ustekinumab 90 mg; Participants will receive 90 mg ustekinumab via SC route.; Other Names: Stelara
Experimental: Placebo; Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.	Drug: Ustekinumab 90 mg; Participants will receive 90 mg ustekinumab via SC route.; Other Names: Stelara; Drug: Placebo; Participants will receive placebo matching to ustekinumab IV or SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52	SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Flare	Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.	Up to Week 52
Percentage of Participants With an SRI-4 Composite Response at Week 24	SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).	Week 24
Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52	The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.	Week 52
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52	Reduction of glucocorticoid dose was defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.	Up to Week 52
Percentage of Participants With at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52	Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.	Week 52
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40, Sustained That Change Through Week 52, and Achieved an SRI-4 Composite Response at Week 52	Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.	Up to Week 52

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General 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.
• van Vollenhoven RF, Kalunian KC, Dorner T, Hahn BH, Tanaka Y, Gordon RM, Shu C, Fei K, Gao S, Seridi L, Gallagher P, Lo KH, Berry P, Zuraw QC. Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus. Ann Rheum Dis. 2022 Jul 7;81(11):1556-63. doi: 10.1136/ard-2022-222858. Online ahead of print.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CR108440; 2017-001489-53 (EudraCT Number); CNTO1275SLE3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No