AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 3NCT03517722

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

A Phase 3 study testing Ustekinumab (approximately 6 mg/kg) and Ustekinumab 90 mg in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 204 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Ustekinumab (approximately 6 mg/kg) and Ustekinumab 90 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
516 participants
Where
204 sitesin 20 countries
Study dates
16 Apr 2018to 5 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
  • 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
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  • 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)

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

204 sites in 20 countries.

204 sites in 20 countries

United States69 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Emory University

    Atlanta, Georgia, 30303

  • Piedmont Healthcare - Piedmont Hospital

    Atlanta, Georgia, 30309

  • University of Colorado

    Aurora, Colorado, 80045

  • Austin Regional Clinic

    Austin, Texas, 78731

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Graves-Gilbert Clinic - Bowling Green

    Bowling Green, Kentucky, 42101

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Columbia Arthritis Center

    Columbia, South Carolina, 29204

  • Medvin Clinical Research

    Covina, California, 91722

  • Arthritis Centers of Texas

    Dallas, Texas, 75246

  • DeKalb Medical Specialty Center

    Decatur, Georgia, 30033

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • St Paul Rheumatology PA

    Eagan, Minnesota, 55121

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33309

  • Lugene Eye Institute

    Glendale, California, 91204

  • C.V. Mehta, MD Medical Corp.

    Hemet, California, 92543

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32207

  • University of California at San Diego

    La Jolla, California, 92093

  • Biomedical Research Alliance Of New York

    Lake Success, New York, 10075

  • Advanced Medical Research - Lakewood

    Lakewood, California, 90712

  • June DO, PC.

    Lansing, Michigan, 48910-8595

  • Oklahoma Medical Research Foundation

    Las Vegas, Nevada, 89102

  • Innovative Health Research

    Las Vegas, Nevada, 89128

  • Loma Linda University

    Loma Linda, California, 92350

  • Loma Linda University Health Care

    Loma Linda, California, 92357

  • Valerius Medical Group & Research Center

    Los Alamitos, California, 90720

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136-1002

  • New Horizon Research Center

    Miami, Florida, 33175

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-3103

  • UPMC Lupus Center of Excellence

    New Haven, Connecticut, 06520

  • NYU Center for Musculoskeletal Care

    New York, New York, 10016

  • Hospital for Special Surgery

    New York, New York, 10021

  • Rheumatology Associates of Central Florida, PA

    Orlando, Florida, 32806

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Millennium Research

    Ormond Beach, Florida, 32174

  • Lewis Katz School of Medicine, Temple University

    Philadelphia, Pennsylvania, 19140

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324

  • Sun Research Institute

    San Antonio, Texas, 78215

  • UT Health Science Center at San Antonio

    San Antonio, Texas, 78239

  • East Bay Rheumatology Medical Group

    San Leandro, California, 94578

  • University of Washington

    Seattle, Washington, 98195

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Westlake Medical Research Clinical Trials

    Thousand Oaks, California, 91360

  • OK Center for Arthritis Therapy & Research, Inc.

    Tulsa, Oklahoma, 74104

  • University Clinical Investigators, Inc

    Tustin, California, 92780

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786

  • Achieve Clinical Research, LLC

    Vestavia Hills, Alabama, 35216

  • Allegheny Rheumatology/Allegheny Singer Research Institute

    Wexford, Pennsylvania, 15090

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan22 sites

  • Chiba University Hospital

    Chiba, 260 8677

  • National Hospital Organization Chiba East Hospital

    Chiba, 260-8712

  • Hospital of the University of Occupational and Enviromental Health

    Fukuoka, 807-8555

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521

  • Kawasaki Rheumatism and Internal Medicine Clinic

    Kitakyushu, 807-0856

  • Toho University Medical Center, Ohashi Hospital

    Meguro-ku, 153-8515

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Sapporo City General Hospital

    Sapporo, 060-8604

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Sasebo Chuo Hospital

    Sasebo, 857 1195

  • Tohoku University Hospital

    Sendai, 980 8574

  • Keio University Hospital

    Shinjuku-ku, 160-8582

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, 162-8655

  • St. Luke's International Hospital

    Tokyo, 104 8560

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • National Hospital Organization Yokohama Medical Center

    Yokohama, 245-8575

Other trials in Japan

Poland10 sites

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Nzoz Bif Med

    Bytom, 41 902

  • Centrum Medyczne AMED oddzial w Lodzi

    Lodz, 91 363

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska

    Sonoswiec, 41-200

  • Centrum Medyczne Pratia Tychy

    Tychy, 43-100

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

  • Reumatika-Centrum Reumatologii, NZOZ

    Warsaw, 02-691

  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

China9 sites

  • The First Affiliated Hospital of Baotou Medical University

    Baotou, 014010

  • Peking Union Medical College Hospital

    Beijing, 100730

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Affiliated Hospital of Inner Mongolia Med U

    Hohhot, 10000

  • Shanghai Ruijin Hospital

    Shanghai, 200025

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Tongji Hospital of Tongji Medical College of Huangzhong Univ

    Wuhan, 430030

  • The 1st affiliated Hospital of Xi'an Traffic University

    Xi'an, 710061

Other trials in China

Spain9 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. de Basurto

    Bilbao, 48013

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Hosp. Univ. Infanta Sofia

    San Sebastián de los Reyes, 28702

  • Hosp. Infanta Luisa

    Seville, 41010

  • Hosp. Do Meixoeiro

    Vigo -Pontevedra, 36214

Other trials in Spain

Argentina8 sites

  • Fundacion CENIT para la Investigacion en Neurociencias

    Buenos Aires, C1025ABI

  • Instituto Centenario

    Buenos Aires, C1204AAP

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

  • Framingham Centro Medico

    Ciudad de La Plata, B1902COS

  • Hospital Italiano de Cordoba

    Córdoba, X5004BAL

  • Hospital Escuela 'Gral. Jose F. de San Martin'

    Corrientes, 3400

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, J5402DIL

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Russia8 sites

  • Regional Clinical Hospital for War Veterans

    Kemerovo, 650000

  • LLL Medical Center Revma-Med

    Kemerovo, 650070

  • Clinical Diagnostic Center 'Ultramed'

    Omsk, 644024

  • Northen-Western State Medical University n.a. I.I. Mechnikov

    Saint Petersburg, 191015

  • Leningrad region clinical hospital

    Saint Petersburg, 194291

  • City Clinical Hospital #31

    Saint Petersburg, 197110

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • Clinical Emergency Hospital n.a. N.V. Solovyev

    Yaroslavl, 150003

Other trials in Russia

Taiwan8 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital

    Kwei-san Hsiang, 333

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10043

  • Cathay General Hospital

    Taipei, 10601

  • Taipei Medical University

    Taipei, 11031

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Serbia7 sites

  • Institute of Rheumatology Belgrade

    Belgrade, 11000

  • Institute of Rheumatology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, 18205

  • Clinical Center of Vojvodina

    Vojvodina, 21000

Other trials in Serbia

Ukraine7 sites

  • Mechnikov Inst, Miska bagatoprofilna likarnia #18

    Kharkiv, 61029

  • Kyiv City Clinical Hospital #3

    Kyiv, 02125

  • Kyivska oblasna klinichna likarnia

    Kyiv, 4107

  • Odeska oblasna klinichna likarnia

    Odesa, 65025

  • Multidisciplinary Medical Center of Odessa National Medical University

    Odesa, 65026

  • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'

    Vinnytsia, 21018

  • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]

    Vinnytsia, 21029

Other trials in Ukraine

Colombia6 sites

  • Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.

    Bogotá, 110221

  • IPS Medicity SAS

    Bucaramanga

  • Servimed S A S

    Bucaramanga

  • Preventive Care Ltda

    Chía, 250001

  • Clinica Universitaria Bolivariana

    Medellín, 050034

  • Funcentra

    Montería, 230002

Other trials in Colombia

Thailand6 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Rajavhiti Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Songklanagarind hospital

    Hat Yai, 90110

  • Chiang Mai University

    Muang, 50200

Other trials in Thailand

Canada5 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • CHU de Québec

    Québec, Quebec, G1V-2L9

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • University of Manitoba

    Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

Germany5 sites

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin, 10117

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Rheumatology Unit

    Leipzig, 04103

  • Universitaetsmedizin Mainz

    Mainz, 55131

Other trials in Germany

Portugal5 sites

  • Instituto Portugues de Reumatologia

    Lisbon, 1050-034

  • Uls Sao Jose - Hosp. Curry Cabral

    Lisbon, 1069-166

  • Hosp. Da Luz Lisboa

    Lisbon, 1500 650

  • ULSAM, EPE - Hospital Conde de Bertiandos

    Ponte de Lima, 4990-041

  • C.H. de Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

South Korea5 sites

  • Daegu Catholic University Medical Center

    Daegu, 705-718

  • Chonbuk National Univ Hospital

    Jeonju, 54907

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University Medical Center

    Seoul, 05030

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Bulgaria4 sites

  • MHAT Trimantium

    Plovdiv, 4000

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431

  • UMHAT St. Ivan Rilski

    Sofia, 1612

  • Medical Centre Synexus

    Sofia, 1709

Other trials in Bulgaria

Lithuania4 sites

  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

    Kaunas, LT-50161

  • Klaipeda University Hospital

    Klaipėda, LT-92288

  • Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil

    Vilnius, 08406

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, LT-08661

Other trials in Lithuania

South Africa4 sites

  • Panorama Medical Centre

    Cape Town, 7500

  • Excellentis Clinical trial Consultants

    George, 6529

  • Clinical Research Unit, University of Pretoria

    Pretoria, 0002

  • Winelands Medical Research Centre

    Stellenbosch, 7613

Other trials in South Africa

Hungary3 sites

  • Szt, Istvan and Szt. Laszlo

    Budapest, 1097

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 5700

  • Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)

    Zalaegerszeg, H-8900

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
Placebo, Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
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.

  • PlaceboDrug

    Participants will receive placebo matching to ustekinumab IV or SC.

  • Ustekinumab (approximately 6 mg/kg)Drug

    Also called Stelara

    Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.

  • Ustekinumab 90 mgDrug

    Also called Stelara

    Participants will receive 90 mg ustekinumab via SC route.

Study groups in NCT03517722
Study groupRoleWhat they receive
UstekinumabExperimentalParticipants 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.
Receives: Drug: Ustekinumab (approximately 6 mg/kg); Drug: Ustekinumab 90 mg
PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Ustekinumab 90 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 52

Secondary outcomes (6)

  1. 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.

    Measured: Up to Week 52

  2. 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).

    Measured: Week 24

  3. 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.

    Measured: Week 52

  4. 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.

    Measured: Up to Week 52

  5. 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.

    Measured: Week 52

  6. 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.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start16 Apr 2018
  3. Primary completion5 Nov 2020
  4. Study completion5 Nov 2020

Why it stopped: Study terminated early as a result of the outcome of the pre-planned Interim Analysis

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03517722
Sponsor's protocol ID
CR108440
Other IDs
2017-001489-53, CNTO1275SLE3001, 2017
Status last verified
Apr 2025
First submitted
13 Apr 2018
Last updated
29 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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 Oct 12;81(11):1556-1563. doi: 10.1136/ard-2022-222858.

    PubMed 35798534

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab (approximately 6 mg/kg) and Ustekinumab 90 mg in people with Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 204 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States, Japan, Poland, China, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03517722, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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