A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT03517722
• Recruitment Status: Terminated
• First Posted: May 7, 2018
• Results First Posted: March 9, 2022
• Last Update Posted: February 2, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lupus Erythematosus, Systemic	Drug: Placebo; Drug: Ustekinumab (approximately 6 mg/kg); Drug: Ustekinumab 90 mg	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 516 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
• Actual Study Start Date: April 16, 2018
• Actual Primary Completion Date: November 5, 2020
• Actual Study Completion Date: November 5, 2020

Arms and Interventions

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 Name: Stelara; Drug: Ustekinumab 90 mg; Participants will receive 90 mg ustekinumab via SC route.; Other Name: 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: Placebo; Participants will receive placebo matching to ustekinumab IV or SC.; Drug: Ustekinumab 90 mg; Participants will receive 90 mg ustekinumab via SC route.; Other Name: Stelara

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 [ Time Frame: 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).

Secondary Outcome Measures :

1. Time to First Flare [ Time Frame: Up to Week 52 ]
   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.
2. Percentage of Participants With an SRI-4 Composite Response at Week 24 [ Time Frame: 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).
3. Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52 [ Time Frame: 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.
4. Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52 [ Time Frame: Up to 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.
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 [ Time Frame: 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.
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 [ Time Frame: Up to 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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Pinnacle Research Group, LLC

Anniston, Alabama, United States, 36207

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Achieve Clinical Research, LLC

Vestavia Hills, Alabama, United States, 35216

United States, California

Medvin Clinical Research

Covina, California, United States, 91722

Lugene Eye Institute

Glendale, California, United States, 91204

C.V. Mehta, MD Medical Corp.

Hemet, California, United States, 92543

University of California at San Diego

La Jolla, California, United States, 92093

Advanced Medical Research - Lakewood

Lakewood, California, United States, 90712

Loma Linda University

Loma Linda, California, United States, 92350

Loma Linda University Health Care

Loma Linda, California, United States, 92357

Valerius Medical Group & Research Center

Los Alamitos, California, United States, 90720

Keck School of Medicine of USC

Los Angeles, California, United States, 90033

Wallace Rheumatic Study Center

Los Angeles, California, United States, 90048

East Bay Rheumatology Medical Group

San Leandro, California, United States, 94578

Westlake Medical Research Clinical Trials

Thousand Oaks, California, United States, 91360

University Clinical Investigators, Inc

Tustin, California, United States, 92780

Inland Rheumatology Clinical Trials Inc.

Upland, California, United States, 91786

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

Denver Arthritis Clinic

Denver, Colorado, United States, 80230

United States, Connecticut

UPMC Lupus Center of Excellence

New Haven, Connecticut, United States, 06520

Stamford Therapeutics Consortium

Stamford, Connecticut, United States, 06905

United States, Florida

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States, 33180

Bay Area Arthritis and Osteoporosis

Brandon, Florida, United States, 33511

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States, 33309

University of Florida Health Jacksonville - Rheumatology

Jacksonville, Florida, United States, 32207

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136-1002

New Horizon Research Center

Miami, Florida, United States, 33175

Rheumatology Associates of Central Florida, PA

Orlando, Florida, United States, 32806

Omega Research Consultants

Orlando, Florida, United States, 32810

Millennium Research

Ormond Beach, Florida, United States, 32174

Integral Rheumatology & Immunology Specialists

Plantation, Florida, United States, 33324

Clinical Research of West Florida

Tampa, Florida, United States, 33603

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

Piedmont Healthcare - Piedmont Hospital

Atlanta, Georgia, United States, 30309

DeKalb Medical Specialty Center

Decatur, Georgia, United States, 30033

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Chicago

Chicago, Illinois, United States, 60637

United States, Kentucky

Graves-Gilbert Clinic - Bowling Green

Bowling Green, Kentucky, United States, 42101

United States, Louisiana

Arthritis and Diabetes Clinic

Monroe, Louisiana, United States, 71203

United States, Maryland

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States, 20902

United States, Michigan

June DO, PC.

Lansing, Michigan, United States, 48910-8595

United States, Minnesota

St Paul Rheumatology PA

Eagan, Minnesota, United States, 55121

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

United States, Nevada

Oklahoma Medical Research Foundation

Las Vegas, Nevada, United States, 89102

Innovative Health Research

Las Vegas, Nevada, United States, 89128

United States, New Mexico

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States, 87102

United States, New York

Biomedical Research Alliance Of New York

Lake Success, New York, United States, 10075

The Feinstein Institute for Medical Research

Manhasset, New York, United States, 11030

NYU Center for Musculoskeletal Care

New York, New York, United States, 10016

Hospital for Special Surgery

New York, New York, United States, 10021

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

United States, North Carolina

Joint and Muscle Research Institute

Charlotte, North Carolina, United States, 28204

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States, 28210

Duke University Medical Center

Durham, North Carolina, United States, 27710

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Oklahoma

OK Center for Arthritis Therapy & Research, Inc.

Tulsa, Oklahoma, United States, 74104

United States, Pennsylvania

Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, United States, 19140

Allegheny Rheumatology/Allegheny Singer Research Institute

Wexford, Pennsylvania, United States, 15090

United States, South Carolina

Columbia Arthritis Center

Columbia, South Carolina, United States, 29204

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

Dr. Ramesh Gupta

Memphis, Tennessee, United States, 38119

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212-3103

United States, Texas

Amarillo Center for Clinical Research

Amarillo, Texas, United States, 79124

Austin Regional Clinic

Austin, Texas, United States, 78731

Arthritis Centers of Texas

Dallas, Texas, United States, 75246

Sun Research Institute

San Antonio, Texas, United States, 78215

UT Health Science Center at San Antonio

San Antonio, Texas, United States, 78239

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

United States, West Virginia

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, United States, 25801

Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina, C1025ABI

Instituto Centenario

Buenos Aires, Argentina, C1204AAP

Centro Privado de Medicina Familiar

Buenos Aires, Argentina, C1417EYG

Framingham Centro Medico

Ciudad De La Plata, Argentina, B1902COS

Hospital Italiano de Cordoba

Cordoba, Argentina, X5004BAL

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

Corrientes, Argentina, 3400

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina, J5402DIL

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina, T4000AXL

Bulgaria

MHAT Trimantium

Plovdiv, Bulgaria, 4000

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, Bulgaria, 1431

UMHAT St. Ivan Rilski

Sofia, Bulgaria, 1612

Medical Centre Synexus

Sofia, Bulgaria, 1709

Canada, Alberta

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Canada, Manitoba

University of Manitoba

Winnipeg, Manitoba, Canada, R3A 1M4

Canada, Ontario

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Canada

McMaster University

Hamilton, Canada, L8N 3Z5

CHU de Québec

Quebec, Canada, G1V-2L9

China

The First Affiliated Hospital of Baotou Medical University

Baotou, China, 014010

Peking Union Medical College Hospital

Beijing, China, 100730

West China Hospital, Sichuan University

Chengdu, China, 610041

Guangdong Provincial People's Hospital

Guangzhou, China, 510080

Affiliated Hospital of Inner Mongolia Med U

Hohhot, China, 10000

Shanghai Ruijin Hospital

Shanghai, China, 200025

Tianjin Medical University General Hospital

Tianjin, China, 300052

Tongji Hospital of Tongji Medical College of Huangzhong Univ

Wuhan, China, 430030

The 1st affiliated Hospital of Xi'an Traffic University

Xi'an, China, 710061

Colombia

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

Bogotá, Colombia, 110221

IPS Medicity SAS

Bucaramanga, Colombia

Servimed S.A.S

Bucaramanga, Colombia

Preventive Care Ltda

Chia, Colombia, 250001

Clinica Universitaria Bolivariana

Medellin, Colombia, 050034

Funcentra

Montería, Colombia, 230002

Germany

Charite - Universitatsmedizin Berlin (CCM)

Berlin, Germany, 10117

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Rheumazentrum Ruhrgebiet

Herne, Germany, 44649

Rheumatology Unit

Leipzig, Germany, 04103

Universitaetsmedizin Mainz

Mainz, Germany, 55131

Hungary

Szt, Istvan and Szt. Laszlo

Budapest, Hungary, 1097

Bekes Megyei Pandy Kalman Korhaz

Gyula, Hungary, 5700

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

Zalaegerszeg, Hungary, H-8900

Japan

Chiba University Hospital

Chiba, Japan, 260-8677

National Hospital Organization Chibahigashi National Hospital

Chiba, Japan, 260-8712

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan, 810-8563

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Japan, 730-8619

Hospital of the University of Occupational and Environmental Health

Hukuoka, Japan, 807-8555

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Japan, 586-8521

Kawasaki Rheumatism and Internal Medicine Clinic

Kitakyushu, Japan, 807-0856

Toho University Medical Center, Ohashi Hospital

Meguro-ku, Japan, 153-8515

Nagasaki University Hospital

Nagasaki-shi, Japan, 852-8501

National Hospital Organization Nagoya Medical Center

Nagoya, Japan, 460-0001

Kitasato University Hospital

Sagamihara, Japan, 252-0375

Hokkaido University Hospital

Sapporo-shi, Japan, 060-8648

Sapporo City General Hospital

Sapporo, Japan, 060-8604

Sasebo Chuo Hospital

Sasebo, Japan, 857-1165

Tohoku University Hospital

Sendai-shi, Japan, 980-8574

Keio University Hospital

Shinjuku-ku, Japan, 160-8582

National Center for Global Health and Medicine

Shinjuku-ku, Japan, 162-8655

St. Luke's International Hospital

Tokyo, Japan, 104-8560

Juntendo University Hospital

Tokyo, Japan, 113-8431

Fujita Health University Hospital

Toyoake, Japan, 470-1192

National Hospital Organization Yokohama Medical Center

Yokohama, Japan, 245-8575

Korea, Republic of

Daegu Catholic University Medical Center

Daegu, Korea, Republic of, 705-718

Chonbuk National Univ Hospital

JeonJu, Korea, Republic of, 54907

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Konkuk University Medical Center

Seoul, Korea, Republic of, 05030

Ajou University Hospital

Suwon, Korea, Republic of, 16499

Lithuania

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, Lithuania, LT-50161

Klaipeda University Hospital

Klaipeda, Lithuania, LT-92288

Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil

Vilnius, Lithuania, 08406

Vilnius University Hospital Santariskiu Clinics

Vilnius, Lithuania, LT-08661

Poland

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz, Poland, 85-168

Nzoz Bif-Med

Bytom, Poland, 41-902

Centrum Medyczne AMED oddzial w Lodzi

Lodz, Poland, 91-363

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Poland, 20-954

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sol, Poland, 67-100

Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska

Sonoswiec, Poland, 41-200

Centrum Medyczne Pratia Tychy

Tychy, Poland, 43-100

Centrum Medyczne Pratia Warszawa

Warszawa, Poland, 01-868

Reumatika-Centrum Reumatologii, NZOZ

Warszawa, Poland, 02-691

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Poland, 50-556

Portugal

Instituto Portugues de Reumatologia

Lisboa, Portugal, 1050-034

Hospital Curry Cabral-Centro Hospital Lisboa Central

Lisboa, Portugal, 1069-166

Hospital da Luz

Lisboa, Portugal, 1500-650

ULSAM, EPE - Hospital Conde de Bertiandos

Ponte de Lima, Portugal, 4990-041

C.H. de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Portugal, 4434-502

Russian Federation

Regional Clinical Hospital for War Veterans

Kemerovo, Russian Federation, 650000

LLL Medical Center Revma-Med

Kemerovo, Russian Federation, 650070

Clinical Diagnostic Center 'Ultramed'

Omsk, Russian Federation, 644024

Leningrad region clinical hospital

Saint-Petersburg, Russian Federation, 194291

City Clinical Hospital #31

St. Petersburg, Russian Federation, 197110

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

St.-Petersburg, Russian Federation, 191015

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russian Federation, 432063

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

Yaroslavl, Russian Federation, 150003

Serbia

Institute of Rheumatology Belgrade

Belgrade, Serbia, 11000

Institute of Rheumatology

Belgrade, Serbia, 11000

Military Medical Academy

Belgrade, Serbia, 11000

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia, 11080

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Institute for Treatment and Rehabilitation Niska Banja

Niska Banja, Serbia, 18205

Clinical Center of Vojvodina

Vojvodina, Serbia, 21000

South Africa

Panorama Medical Centre

Cape Town, South Africa, 7500

Excellentis Clinical trial Consultants

George, South Africa, 6529

Clinical Research Unit, University of Pretoria

Pretoria, South Africa, 0002

Winelands Medical Research Centre

Stellenbosch, South Africa, 7613

Spain

Hosp. Univ. Vall D Hebron

Barcelona, Spain, 8035

Hosp. Univ. de Basurto

Bilbao, Spain, 48013

Hosp. Reina Sofia

Cordoba, Spain, 14004

Hosp. Clinico San Carlos

Madrid, Spain, 28040

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Hosp. Regional Univ. de Malaga

Málaga, Spain, 29009

Hosp. Univ. Infanta Sofia

San Sebastián de los Reyes, Spain, 28702

Hosp. Infanta Luisa

Sevilla, Spain, 41010

Hosp. Do Meixoeiro

Vigo -Pontevedra, Spain, 36214

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Chang Gung Memorial Hospital

Kwei-san Hsiang, Taiwan, 333

Chung Shan Medical University Hospital

Taichung, Taiwan, 402

China Medical University Hospital

Taichung, Taiwan, 40447

National Taiwan University Hospital

Taipei, Taiwan, 10043

Cathay General Hospital

Taipei, Taiwan, 10601

Taipei Medical University

Taipei, Taiwan, 11031

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Thailand

Phramongkutklao Hospital and Medical College

Bangkok, Thailand, 10400

Rajavhiti Hospital

Bangkok, Thailand, 10400

Ramathibodi Hospital

Bangkok, Thailand, 10400

Siriraj Hospital

Bangkok, Thailand, 10700

Songklanagarind hospital

Hat Yai, Thailand, 90110

Chiang Mai University

Muang, Thailand, 50200

Ukraine

Mechnikov Inst, Miska bagatoprofilna likarnia #18

Kharkiv, Ukraine, 61029

Kyiv City Clinical Hospital #3

Kyiv, Ukraine, 02125

Kyivska oblasna klinichna likarnia

Kyiv, Ukraine, 4107

Odeska oblasna klinichna likarnia

Odesa, Ukraine, 65025

Multidisciplinary Medical Center of Odessa National Medical University

Odessa, Ukraine, 65026

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

Vinnytsia, Ukraine, 21018

Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]

Vinnytsia, Ukraine, 21029

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] January 23, 2019

Statistical Analysis Plan  [PDF] September 23, 2020

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03517722
• Other Study ID Numbers: CR108440; 2017-001489-53 ( EudraCT Number ); CNTO1275SLE3001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: May 7, 2018
• Results First Posted: March 9, 2022
• Last Update Posted: February 2, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Ustekinumab; Dermatologic Agents