AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3SELECT-SLENCT05843643

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

A Phase 3 study testing Upadacitinib in people with Systemic Lupus Erythematosus, run by AbbVie at 369 sites in 38 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Read more about this study

Who is it for?
Ages 18 to 63 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,014 participants
Where
369 sitesin 38 countries
Study dates
25 Jul 2023to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 63 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
  • At Screening, must have at least one of the following:
  • antinuclear antibody (ANA) positive (titer >= 1:80)
  • anti-double stranded deoxyribonucleic acid (dsDNA) positive
  • anti-Smith positive
  • Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
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  • Physician's Global Assessment (PhGA) >= 1 during screening period.
  • On stable background treatment for >= 60 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with
  • antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily];
  • and/or prednisone (or prednisone-equivalent) (<= 20 mg daily);
  • and/or no more than 1 of the following: azathioprine (<= 150 mg daily), 6-mercaptopurine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<= 150 mg daily).

Who cannot join

  • Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
  • Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
  • SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
  • Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
  • Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
  • History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
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  • Pregnancy, breastfeeding, or considering becoming pregnant during the study.
  • Clinically relevant or significant ECG abnormalities at Screening.
  • Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

369 sites in 38 countries.

369 sites in 38 countries

United States132 sites

  • Arthritis and Rheumatology Research Institute, PLLC /ID# 253014

    Allen, Texas, 75013-6147

  • Kaiser Permanente Lakeview Medical Offices /ID# 253906

    Anaheim, California, 92807-3028

  • Rheumatology Associates /ID# 276066

    Arlington, Texas, 76012

  • Emory University School Of Medicine - Atlanta /ID# 261529

    Atlanta, Georgia, 30322

  • University of Colorado Hospital /ID# 253184

    Aurora, Colorado, 80045

  • Arthritis and Rheumatic Disease Specialties /ID# 253624

    Aventura, Florida, 33180

  • HARAC Research Corp. /ID# 254922

    Avon Park, Florida, 33825-2958

  • University of Maryland, Baltimore /ID# 262556

    Baltimore, Maryland, 21201

  • Rheumatology & Pulmonary Clinic /ID# 273561

    Beckley, West Virginia, 25801

  • David S. Hallegua MD, A Professional Corporation /ID# 253902

    Beverly Hills, California, 90211

  • Wallace and Lee Center /ID# 275129

    Beverly Hills, California, 90211

  • Wallace Rheumatic Studies Center, LLC /ID# 252806

    Beverly Hills, California, 90211

  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623

    Boca Raton, Florida, 33486

  • Mdr Core Network, Inc /Id# 276704

    Boynton Beach, Florida, 33426

  • Bay Area Arthritis and Osteo /ID# 253597

    Brandon, Florida, 33511

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592

    Brooklyn, New York, 11201-5501

  • AZ Arthritis and Rheumatology /ID# 261848

    Chandler, Arizona, 85225-2906

  • Joint And Muscle Research Institute /ID# 272845

    Charlotte, North Carolina, 28204

  • DJL Clinical Research, PLLC /ID# 253620

    Charlotte, North Carolina, 28211

  • University of Illinois Hospital and Health Sciences System /ID# 263014

    Chicago, Illinois, 60607

  • Northwestern University Feinberg School of Medicine /ID# 264090

    Chicago, Illinois, 60611-2927

  • Next Innovative Clinical Research - Chicago /ID# 268739

    Chicago, Illinois, 60616

  • University of Chicago Medical Center /ID# 263162

    Chicago, Illinois, 60637

  • Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870

    Chula Vista, California, 91910

  • University of Cincinnati Medical Center /ID# 259174

    Cincinnati, Ohio, 45219-2364

  • Clinical Research Institute Of Michigan /ID# 273051

    Clinton Township, Michigan, 48038

  • GNP Consultants, dba, GNP Research /ID# 272868

    Cooper City, Florida, 33024

  • Duplicate_Believe Clinical Trials /ID# 255427

    Coral Springs, Florida, 33065

  • Arthritis Care of Texas /ID# 261719

    Corpus Christi, Texas, 78415-1800

  • International Medical Research /ID# 253617

    Daytona Beach, Florida, 32117

  • Omega Research Debary, LLC /ID# 254939

    DeBary, Florida, 32713-2260

  • Denver Arthritis Clinic /ID# 253189

    Denver, Colorado, 80230

  • Texas Arthritis Center /ID# 277049

    El Paso, Texas, 79902

  • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767

    Flagstaff, Arizona, 86001-6299

  • JPS Rheumatology Clinic /ID# 253185

    Fort Worth, Texas, 76104-4917

  • Arthiritis and Rheumatology Specialists PA /ID# 255950

    Fort Worth, Texas, 76177

  • Providence - St. Jude Medical Center /ID# 252822

    Fullerton, California, 92835

  • University of Florida /ID# 261984

    Gainesville, Florida, 32610-3008

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820

    Gilbert, Arizona, 85297-7336

  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824

    Glendale, Arizona, 85306-9802

  • AA Medical Research Center - Grand Blanc /ID# 253028

    Grand Blanc, Michigan, 48439

  • Finlay Medical Research - Greenacres /ID# 274902

    Greenacres City, Florida, 33467

  • Integrative Rheumatology of South Texas - Harlingen /ID# 261977

    Harlingen, Texas, 78550

  • Private Practice - Dr. Chandrakant V. Mehta /ID# 275100

    Hemet, California, 92543

  • Evolution Research Center /ID# 272991

    Hialeah, Florida, 33012

  • Neoclinical Research /ID# 253614

    Hialeah, Florida, 33016-1897

  • South Florida Rheumatology /ID# 268525

    Hollywood, Florida, 33026

  • Western KY Rheumatology /ID# 254937

    Hopkinsville, Kentucky, 42240

  • Accurate Clinical Research - Houston /ID# 276220

    Houston, Texas, 77089-6142

  • Newport Huntington Medical Group /ID# 252827

    Huntington Beach, California, 92648-5994

  • West Tennessee Research Institute /ID# 252807

    Jackson, Tennessee, 38305

  • Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272

    Jacksonville, Florida, 32216

  • UF Health Rheumatology /ID# 255351

    Jacksonville, Florida, 32256

  • Arthritis and Rheumatism Associates /ID# 253033

    Jonesboro, Arkansas, 72401-6251

  • Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808

    Kalispell, Montana, 59901

  • Kansas City Physician Partners /ID# 254786

    Kansas City, Missouri, 64151

  • Accurate Clinical Research Katy /ID# 276459

    Katy, Texas, 77449

  • R & H Clinical Research - Katy /ID# 254126

    Katy, Texas, 77450-2244

  • Biopharma Informatic /ID# 273651

    Katy, Texas, 77494

  • Trinity Research Centers /ID# 262039

    Kennesaw, Georgia, 30144-1762

  • Moores Cancer Center at UC San Diego /ID# 253903

    La Jolla, California, 92093

  • Arthritis & Osteo Medical Ctr /ID# 252812

    La Palma, California, 90623-1728

  • Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647

    Lake Charles, Louisiana, 70605

  • June DO, PC /ID# 253030

    Lansing, Michigan, 48911

  • Arthritis and Osteoporosis Associates of New Mexico /ID# 252818

    Las Cruces, New Mexico, 88011

  • Dartmouth-Hitchcock Medical Center /ID# 254923

    Lebanon, New Hampshire, 03756

  • Wagdy Kades, M.D., Inc /ID# 272065

    Los Angeles, California, 90017

  • Life Clinical Trials /ID# 253615

    Margate, Florida, 33063

  • Atlanta Research Center For Rheumatology - Marietta /ID# 253610

    Marietta, Georgia, 30060

  • Valley Arthritis Center /ID# 253022

    McAllen, Texas, 78501-1401

  • Shelby Research /ID# 256937

    Memphis, Tennessee, 38119

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845

    Mesa, Arizona, 85210-6871

  • Lakes Research, LLC /ID# 253621

    Miami, Florida, 33014

  • University of Miami, Division of Rheumatology /ID# 261594

    Miami, Florida, 33136-2107

  • Ezy Medical Research /ID# 276221

    Miami, Florida, 33175

  • Paramount Medical Research and Consulting /ID# 253016

    Middleburg Heights, Ohio, 44130

  • Wisconsin Medical Center /ID# 256660

    Milwaukee, Wisconsin, 53226

  • Illinois Bone & Joint Institute - Morton /ID# 274455

    Morton, Illinois, 60053

  • Yale University School of Medicine /ID# 254567

    New Haven, Connecticut, 06510

  • NYU Langone Orthopedic Center /ID# 253613

    New York, New York, 10016-2772

  • Oklahoma Medical Research Foundation /ID# 263509

    Oklahoma City, Oklahoma, 73104

  • Rheumatology Associates of Oklahoma /ID# 253012

    Oklahoma City, Oklahoma, 73116-7226

  • Advanced Quality Medical Research /ID# 254983

    Orland Park, Illinois, 60462

  • HMD Research LLC /ID# 253595

    Orlando, Florida, 32819

  • University of Central Florida /ID# 261112

    Orlando, Florida, 32827-7664

  • Millennium Research /ID# 253600

    Ormond Beach, Florida, 32174

  • Vitalia Research /ID# 272642

    Palm Beach Gardens, Florida, 33410

  • Arizona Arthritis & Rheumatology Research /ID# 273555

    Peoria, Arizona, 85381

  • Clinical Research Source, Inc. /ID# 253027

    Perrysburg, Ohio, 43551

  • Clinical Research of Philadelphia, LLC /ID# 254156

    Philadelphia, Pennsylvania, 19114

  • Albert Einstein Medical Center /ID# 256661

    Philadelphia, Pennsylvania, 19141

  • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831

    Phoenix, Arizona, 85032

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825

    Phoenix, Arizona, 85037

  • University of Pittsburgh Medical Center /ID# 263686

    Pittsburgh, Pennsylvania, 15213

  • Texas Rheumatology Research Institute Llc /Id# 253013

    Plano, Texas, 75024

  • Believe Clinical Trials /ID# 277004

    Plant City, Florida, 33563

  • IRIS Research and Development, LLC /ID# 253618

    Plantation, Florida, 33324

  • St. Lawrence Health System /ID# 253598

    Potsdam, New York, 13676

  • Raleigh Medical Group /ID# 256328

    Raleigh, North Carolina, 27609

  • Epic Medical Research /ID# 255326

    Red Oak, Texas, 75154

  • Carilion Roanoke Memorial Hospital /ID# 253374

    Roanoke, Virginia, 24014

  • OrthoIllinois /ID# 253188

    Rockford, Illinois, 61114-4937

  • Arthritis and Rheumatology Center PC /ID# 275994

    Roswell, Georgia, 30076

  • Accellacare - Salisbury /ID# 253608

    Salisbury, North Carolina, 28144-2735

  • Sun Research Institute /ID# 255832

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc /ID# 254949

    San Antonio, Texas, 78229

  • Epic Medical Research- San Marcos /ID# 278360

    San Marcos, Texas, 78666

  • Inspire Santa Fe Medical Group /ID# 275947

    Santa Fe, New Mexico, 87505

  • Providence St. Johns Health Center /ID# 253905

    Santa Monica, California, 90404-2303

  • Greater Chicago Specialty Physicians /ID# 253021

    Schaumburg, Illinois, 60195-3106

  • HonorHealth Rheumatology /ID# 261953

    Scottsdale, Arizona, 85258-4668

  • Willis Knighton /ID# 256343

    Shreveport, Louisiana, 71103-3920

  • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020

    Skokie, Illinois, 60076

  • NorthShore University HealthSystem - Skokie /ID# 254568

    Skokie, Illinois, 60077

  • BayCare Medical Group /ID# 253593

    St. Petersburg, Florida, 33705

  • Fort Bend Rheumatology Associates, PLLC /ID# 268492

    Sugar Land, Texas, 77479

  • Low Country Rheumatology /ID# 272956

    Summerville, South Carolina, 29486

  • Immunology and Rheumatology Research Associates LLC /ID# 267582

    Suwanee, Georgia, 30024-7290

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602

    Tampa, Florida, 33606

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899

    Tampa, Florida, 33606

  • Baycare Medical Group - Tampa /ID# 255135

    Tampa, Florida, 33614

  • Urban Health Plan /ID# 268059

    The Bronx, New York, 10459

  • Millennium Clinical Trials /ID# 252817

    Thousand Oaks, California, 91360-3951

  • Cohen Medical Centers /ID# 268524

    Thousand Oaks, California, 91360

  • DM Clinical Research - Tomball /ID# 255134

    Tomball, Texas, 77375

  • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828

    Tucson, Arizona, 85704

  • Solace Research /ID# 275198

    Tustin, California, 92780

  • Upland Rheumatology Center /ID# 268623

    Upland, California, 91786

  • Deerbrook Medical Associates /ID# 253029

    Vernon Hills, Illinois, 60061

  • Willow Rheumatology and Wellness, PLLC /ID# 253018

    Willowbrook, Illinois, 60527

  • Atrium Health Wake Forest Baptist Medical Center /ID# 254125

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center /ID# 262742

    Worcester, Massachusetts, 01655

Other trials in United States

China40 sites

  • China-Japan Friendship Hospital /ID# 253048

    Beijing, Beijing Municipality, 100029

  • Peking University Third Hospital /ID# 253138

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045

    Beijing, Beijing Municipality, 100730

  • The first affiliated hospital of bengbu medical college /ID# 252853

    Bengbu, Anhui, 233004

  • The First Hospital of Jilin University /ID# 252771

    Changchun, Jilin, 130021

  • The First People's Hospital of Changzhou /ID# 252992

    Changzhou, Jiangsu, 213003

  • West China Hospital, Sichuan University /ID# 252854

    Chengdu, Sichuan, 610041

  • Guangdong Provincial Peoples Hospital /ID# 252920

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Sun Yat-sen University /ID# 252921

    Guangzhou, Guangdong, 510080

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital Of Guangzhou Medical University /ID# 252927

    Guangzhou, Guangdong, 510163

  • The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923

    Guangzhou, Guangdong, 510630

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People's Hospital /ID# 253860

    Hangzhou, Zhejiang, 310014

  • The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629

    Hohhot, Inner Mongolia, 010050

  • Jining No.1 People's Hospital /ID# 252897

    Jining, Shandong, 272001

  • The First People's Hospital of Jiujiang /ID# 252989

    Jiujiang, Jiangxi, 332000

  • First Affiliated Hospital of Kunming Medical University /ID# 252925

    Kunming, Yunnan, 650032

  • Linyi People's Hospital /ID# 252898

    Linyi, Shandong, 276034

  • The First Affiliated Hospital Of Henan University Of Science &Technology /ID# 272929

    Luoyang, Henan, 471003

  • Mianyang Central Hospital /ID# 272850

    Mianyang, Sichuan, 621000

  • Jiangxi Provincial People's Hospital /ID# 252940

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 253042

    Nanjing, Jiangsu, 210008

  • The First Affiliated Hospital Of Guangxi Medical University /ID# 272798

    Nanning, Guangxi, 530021

  • Affiliated hospital of nantong university /ID# 252991

    Nantong, Jiangsu, 226001

  • Jiangxi Pingxiang Peoples Hospital /ID# 252919

    Pingxiang, Jiangxi, 337055

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 263435

    Shanghai, Shanghai Municipality, 200001

  • The First Affiliated Hospital of Shantou University Medical College /ID# 253426

    Shantou, Guangdong, 515041

  • Tianjin Medical University General Hospital /ID# 252868

    Tianjin, Tianjin Municipality, 300052

  • People's Hospital of Xinjiang Uygur Autonomous Region /ID# 266897

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 253649

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 252632

    Wuhan, Hubei, 430030

  • Wuxi People's Hospital /ID# 253858

    Wuxi, Jiangsu, 214023

  • Second Affiliated Hospital of Xian Jiaotong University /ID# 252861

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xiamen University /ID# 252630

    Xiamen, Fujian, 361003

  • Xuzhou Central Hospital /ID# 252922

    Xuzhou, Jiangsu, 221009

  • Yancheng First People's Hospital /ID# 254599

    Yancheng, Jiangsu, 224001

  • Northern Jiangsu People's Hospital /ID# 252945

    Yangzhou, Jiangsu, 225001

  • Zhuzhou Central Hospital /ID# 252962

    Zhuzhou, Hunan, 412007

Other trials in China

Japan11 sites

  • Institute of Science Tokyo Hospital /ID# 254430

    Bunkyo-ku, Tokyo, 113-8519

  • National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 253268

    Chiba, 260-8712

  • University of Yamanashi Hospital /ID# 253264

    Chuo-shi, Yamanashi, 409-3898

  • Hiroshima University Hospital /ID# 273658

    Hiroshima, 734-8551

  • Saitama Medical Center /ID# 253263

    Kawagoe, Saitama, 350-8550

  • Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 253269

    Kitakyushu-shi, Fukuoka, 807-8556

  • University of Miyazaki Hospital /ID# 253416

    Miyazaki, Miyazaki, 889-1692

  • Shinkenko Clinic /ID# 253271

    Naha, Okinawa, 900-0015

  • Okayama University Hospital /ID# 253821

    Okayama, Okayama-ken, 700-8558

  • Hokkaido University Hospital /ID# 253306

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 253267

    Sendai, Miyagi, 9808574

Other trials in Japan

Argentina10 sites

  • Fundación Sanatorio Guemes /ID# 254283

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1180

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 254278

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1426

  • Organizacion Medica de Investigacion (OMI) /ID# 254281

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1015

  • Fundacion CIDEA /ID# 254279

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1121

  • Instituto Medico Especializado /ID# 255281

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1405

  • Aprillus Asistencia e Investigacion /ID# 254276

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1958

  • Hospital Italiano La Plata /ID# 254284

    La Plata, Buenos Aires, 1900

  • CER Instituto Medico /ID# 255302

    Quilmes, Buenos Aires, 1878

  • Instituto CAICI S.R.L /ID# 254280

    Rosario, Santa Fe Province, 2000

  • Centro de Investigaciones Medicas Tucuman /ID# 254274

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil9 sites

  • Nossa Saude Pesquisa Ltda. /ID# 253274

    Curitiba, Paraná, 80440-210

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital de Clinicas de Porto Alegre /ID# 253357

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 253353

    Porto Alegre, Rio Grande do Sul, 90480-000

  • SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354

    Salvador, Estado de Bahia, 40150-150

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital do Rim /ID# 253983

    São Paulo, 04038-002

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316

    São Paulo, 05403-000

  • CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Bulgaria9 sites

  • Umbal Kaspela /ID# 252645

    Plovdiv, 4001

  • Medical Center Artmed Ltd /Id# 254572

    Plovdiv, 4002

  • Medical center Unimed /ID# 253324

    Plovdiv, 4023

  • Medical center Teodora /ID# 252646

    Rousse, 7012

  • Military Medical Academy Multiprofile Hospital /ID# 252644

    Sofia, 1606

  • Medical Center Academy /ID# 253322

    Sofia, 1612

  • Mc Excelsior /ID# 272499

    Sofiya, Sofia, 1407

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252642

    Sofiya, Sofia, 1463

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252643

    Sofiya, Sofia, 1463

Other trials in Bulgaria

Australia8 sites

  • Emeritus Research Sydney /ID# 256249

    Botany, New South Wales, 2019

  • Emeritus Research /ID# 256800

    Camberwell, Victoria, 3124

  • Monash Health - Monash Medical Centre /ID# 255678

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital /ID# 257945

    Concord, New South Wales, 2139

  • Momentum Clinical Research /ID# 253542

    Darlinghurst, New South Wales, 2010

  • Royal Darwin Hospital /ID# 263160

    Tiwi, Northern Territory, 0811

  • Colin Bayliss Research and Teaching Unit /ID# 261077

    Victoria Park, Western Australia, 6100

  • The Queen Elizabeth Hospital /ID# 253826

    Woodville, South Australia, 5011

Other trials in Australia

Serbia8 sites

  • Institute for Rheumatology /ID# 253172

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 253173

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 253174

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 253175

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 264235

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 253179

    Belgrade, Beograd, 11080

  • University Clinical Center Vojvodina /ID# 253176

    Novi Sad, 21000

  • General Hospital Djordje Joanovic /ID# 253177

    Zrenjanin, Vojvodina, 23000

Other trials in Serbia

Turkey (Türkiye)8 sites

  • Akdeniz Universitesi Tip Fakul /ID# 252839

    Antalya, 07059

  • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 253557

    Istanbul, 34480

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 252844

    Istanbul, 34899

  • Necmettin Erbakan Universitesi /ID# 252837

    Meram Konya, 42080

  • Sanko Universitesi Hastanesi /ID# 252841

    Şehitkamil, Gaziantep, 27090

  • Hacettepe Universitesi Tip Fak /ID# 253266

    Sihhiye, Ankara, Ankara, 06100

  • Karadeniz Technical University Farabi Hospital /ID# 252845

    Trabzon, 61080

  • Gazi Universitesi Tip Fakultes /ID# 252843

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

Mexico7 sites

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253966

    Guadalajara, Jalisco, 44650

  • Grupo Clinico Catei Sociedad Civil /Id# 257700

    Guadalajara, Jalisco, 44657

  • Morales Vargas Centro de Investigacion S.C. /ID# 254661

    León, Guanajuato, 37000

  • Medical Care & Research SA de CV /ID# 260825

    Mérida, Yucatán, 97070

  • Hospital de Jesus /ID# 255146

    Mexico City, Mexico City, 06090

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 253965

    Mexico City, Mexico City, 11850

  • Centro de Investigacion Medica Dr. Alberto Bazzoni CIMAB S.A de C.V. /ID# 261462

    Torreón, Coahuila, 27000

Other trials in Mexico

South Africa7 sites

  • Winelands Medical Research - Somerset West /ID# 254614

    Cape Town, Western Cape, 7130

  • Arthritis Clinical Research Trials /ID# 253349

    Cape Town, Western Cape, 7405

  • Wits Clinical Research /ID# 252931

    Johannesburg, Gauteng, 1864

  • University of Pretoria /ID# 252932

    Pretoria, Gauteng, 0001

  • Dr Elsa van Duuren /ID# 254218

    Pretoria, Gauteng, 0002

  • Winelands Medical Research Centre /ID# 252934

    Stellenbosch, Western Cape, 7600

  • Dr Asokan Naidoo /ID# 253351

    Umhlanga, KwaZulu-Natal, 4319

Other trials in South Africa

United Kingdom7 sites

  • North West Anglia NHS Foundation Trust /ID# 254590

    Bretton, Cambridgeshire, PE3 9GZ

  • Guy's Hospital /ID# 252978

    London, Greater London, SE1 9RT

  • Western Health and Social Care Trust /ID# 254592

    Londonderry, Northern Ireland, BT47 6SB

  • Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323

    Luton, LU4 0DZ

  • Northampton General Hospital NHS Trust /ID# 254813

    Northampton, Northamptonshire, NN1 5BD

  • Portsmouth Hospitals University NHS Trust /ID# 252986

    Portsmouth, PO6 3LY

  • University Hospital Southampton NHS Foundation Trust /ID# 252982

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Colombia6 sites

  • Clinica de la Costa S.A.S /ID# 260727

    Barranquilla, 080020

  • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097

    Bogotá, Cundinamarca, 110221

  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100

    Bucaramanga, Santander Department, 681004

  • IPS Suramericana SAS - IPS Sura San Diego /ID# 261536

    Medellín, Antioquia, 050016

  • Hospital Pablo Tobón Uribe /ID# 254101

    Medellín, Antioquia, 050034

  • Healthy Medical Center S.A.S /ID# 254098

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Croatia6 sites

  • Klinicki bolnicki centar Osijek /ID# 252847

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Rijeka /ID# 252848

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 252849

    Split, Split-Dalmatia County, 21000

  • Opća Bolnica Zadar /ID# 272415

    Zadar, Zadar County, 23000

  • Poliklinika Bonifarm /ID# 252846

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 252965

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Israel6 sites

  • The Lady Davis Carmel Medical Center /ID# 253303

    Haifa, 34362

  • Hadassah Medical Center-Hebrew University /ID# 252654

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 254187

    Kfar Saba, Central District, 4428164

  • Galilee Medical Center /ID# 252859

    Nahariya, Northern District, 2210001

  • The Chaim Sheba Medical Center /ID# 252857

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 252858

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Bosnia and Herzegovina5 sites

  • Institute of Physical Medicine,Rehab. and Orthopedic Surgery Dr.Miroslav Zotovic /ID# 262588

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 253581

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 253582

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 253583

    Sarajevo, 71000

  • Polyclinic Srce Sarajeva /ID# 255475

    Sarajevo, 71210

Other trials in Bosnia and Herzegovina

Canada5 sites

  • University of Calgary /ID# 259515

    Calgary, Alberta, T2N 4Z6

  • University of Alberta Hospital /ID# 259516

    Edmonton, Alberta, T6G 2B7

  • CIUSSS de l'Estrie - CHUS /ID# 254716

    Sherbrooke, Quebec, J1G 2E8

  • Toronto Western Hospital /ID# 254017

    Toronto, Ontario, M5T 2S8

  • University of Manitoba /ID# 259517

    Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 254841

    Concepción, Biobio, 4070038

  • Inmunocel /Id# 256390

    Las Condes, Santiago Metropolitan, 7580206

  • Investigaciones Medicas Limitada /Id# 254842

    Providencia, 7500710

  • Centro Internacional de Estudios Clinicos - CIEC /ID# 254838

    Santiago, Region Metropolitana Santiago, 8420383

  • Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179

    Victoria, Araucania, 4720000

Other trials in Chile

Germany5 sites

  • Immanuel Krankenhaus Berlin /ID# 253389

    Buch, 13125

  • Krankenhaus Porz am Rhein /ID# 254373

    Cologne, North Rhine-Westphalia, 51149

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 270832

    Dresden, Saxony, 01307

  • Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734

    Frankfurt am Main, 60596

  • Universitaetsmedizin Mainz /ID# 260735

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Hungary5 sites

  • Debreceni Egyetem-Klinikai Kozpont /ID# 252877

    Debrecen, Hajdú-Bihar, 4032

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 252886

    Gyula, 5700

  • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552

    Pécs, Baranya, 7624

  • Vita Verum Medical Bt. /ID# 273579

    Székesfehérvár, Szekesfehervar, 8000

  • Vital-Medicina Kft. /ID# 252876

    Veszprém, Fejér, 8200

Other trials in Hungary

Italy5 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 254138

    Ancona, 60020

  • Azienda Ospedale-Universita Padova /ID# 253704

    Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana /ID# 254289

    Pisa, 56126

  • Azienda Ospedaliera San Camillo Forlanini /ID# 253680

    Rome, Roma, 00149

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254288

    Rome, Roma, 00161

Other trials in Italy

Latvia5 sites

  • M & M Centrs LTD /ID# 253752

    Adazi, LV-2164

  • Daugavpils Regional Hospital /ID# 253754

    Daugavpils, LV-5401

  • Dr. Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 273246

    Liepāja, LV-3401

  • Riga East Clinical University Hospital /ID# 253751

    Riga, Riga, 1038

  • Pauls Stradins Clinical University Hospital /ID# 253750

    Riga, LV-1002

Other trials in Latvia

Lithuania5 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755

    Kaunas, 50161

  • Republic Klaipeda Hospital /ID# 253759

    Klaipėda, 92253

  • Klaipeda University Hospital, Klaipeda Hospital /ID# 253757

    Klaipėda, 92288

  • Inlita - Santara KTC /ID# 253758

    Vilnius, 08406

  • Vilnius University Hospital Santaros Klinikos /ID# 253756

    Vilnius, 08661

Other trials in Lithuania

Poland5 sites

  • MICS Centrum Medyczne Bydgoszcz /ID# 253281

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • ETYKA-Osrodek Badan Klinicznych /ID# 252967

    Olsztyn, Warmian-Masurian Voivodeship, 10-117

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964

    Poznan, Greater Poland Voivodeship, 61-545

  • MICS Centrum Medyczne Warszawa /ID# 253273

    Warsaw, Masovian Voivodeship, 00-874

Other trials in Poland

Puerto Rico5 sites

  • Clinical Research Investigator Group /ID# 259170

    Bayamón, 00960

  • Clinical Research Puerto Rico /ID# 256352

    San Juan, 00909-1711

  • GCM Medical Group /ID# 253039

    San Juan, 00917-3104

  • CMRC Headlands LLC /ID# 254882

    San Juan, 00918-3501

  • Mindful Medical Research /ID# 253040

    San Juan, 00918-3756

Other trials in Puerto Rico

Slovakia5 sites

  • ARTROMAC n.o. /ID# 253056

    Košice, Košice Region, 040 11

  • ZAZABIE s. r .o. /ID# 255793

    Košice II, 040 11

  • MEDMAN s.r.o. /ID# 252950

    Martin, Žilina Region, 036 01

  • Narodny Ustav Reumatickych Chorob Piestany /ID# 273341

    Piešťany, Trnava Region, 921 12

  • Thermium s.r.o. /ID# 260839

    Piešťany, 921 01

Other trials in Slovakia

South Korea5 sites

  • SoonChunHyang University Hospital Cheonan /ID# 254777

    Cheonan-si, Chungcheongnam-do, 31151

  • Chonnam National University Bitgoeul Hospital /ID# 254675

    Gwangju, Gwangju Gwang Yeogsi, 61748

  • Hanyang University Seoul Hospital /ID# 252955

    Seoul, Seoul Teugbyeolsi, 04763

  • Asan Medical Center /ID# 254022

    Seoul, Seoul Teugbyeolsi, 05505

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958

    Seoul, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Estonia4 sites

  • Innomedica /ID# 253722

    Tallinn, Harju, 10117

  • East Tallinn Central Hospital - Magdaleena Unit /ID# 253721

    Tallinn, Harju, 11312

  • North Estonia Medical Centre Foundation /ID# 253723

    Tallinn, Harju, 13419

  • MediTrials /ID# 253720

    Tartu, Tartu, 50708

Other trials in Estonia

Guatemala4 sites

  • Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156

    Guatemala City, 01010

  • Clinica Medica Reumatologica /ID# 255009

    Guatemala City, 01010

  • Clinica Especializada en Medicina Interna /ID# 255006

    Guatemala City, 01011

  • Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248

    Guatemala City, zona 10

Other trials in Guatemala

Portugal4 sites

  • Hospital Garcia de Orta /ID# 252903

    Almada, Setúbal District, 2805-267

  • Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911

    Guilhufe, Porto District, 4560-136

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902

    Ponte de Lima, Viana do Castelo District, 4990-041

  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899

    Porto, 4099-001

Other trials in Portugal

Belgium3 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 261997

    Anderlecht, Brussels Capital, 1070

  • Universitair Ziekenhuis Brussel /ID# 269065

    Jette, Brussels Capital, 1090

  • ZAS Palfijn /ID# 252802

    Merksem, Antwerpen, 2170

Other trials in Belgium

France3 sites

  • HCL - Hopital de la Croix-Rousse /ID# 254147

    Lyon, Rhone, 69004

  • Hopital Pitie Salpetriere /ID# 253009

    Paris, Île-de-France Region, 75013

  • CHU Toulouse - Hopital Rangueil /ID# 254148

    Toulouse, Haute-Garonne, 31400

Other trials in France

Greece3 sites

  • General Hospital of Athens Laiko /ID# 252952

    Athens, Attica, 11527

  • University General Hospital Attikon /ID# 253209

    Athens, Attica, 12462

  • University General Hospital of Heraklion PA.G.N.I /ID# 252951

    Heraklion, Crete, 71500

Other trials in Greece

Romania3 sites

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207

    Brasov, 500283

  • Spitalul Clinic Sf. Maria /ID# 252905

    Bucharest, 011172

  • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

Spain3 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 253123

    A Coruña, A Coruna, 15006

  • Hospital Universitario Virgen de Valme /ID# 253121

    Seville, 41014

  • Hospital Meixoeiro (CHUVI) /ID# 253124

    Vigo, Pontevedra, 36213

Other trials in Spain

Switzerland3 sites

  • University Hospital Basel /ID# 252907

    Basel Town, Canton of Basel-City, 4031

  • Inselspital, Universitaetsspital Bern /ID# 252909

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 252906

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Taiwan3 sites

  • Chang Gung Mem Hosp Keelung /ID# 253636

    Keelung, 204

  • China Medical University Hospital /ID# 252936

    Taichung, 40447

  • National Taiwan University Hospital /ID# 252937

    Taipei City, Taipei, 100

Other trials in Taiwan

New Zealand2 sites

  • Aotearoa Clinical Trials /ID# 253555

    Papatoetoe, Auckland, 2025

  • North Shore Hospital /ID# 253554

    Takapuna, Auckland, 0622

Other trials in New Zealand

About this study

Official title: SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.

Read more

Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Being tested
Upadacitinib, Placebo
Keywords
Systemic Lupus Erythematosus, SLE, Upadacitinib, Lupus
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.

  • UpadacitinibDrug

    Also called RINVOQ

    Oral Tablets

  • PlaceboDrug

    Oral Tablet

Study groups in NCT05843643
Study groupRoleWhat they receive
Study 1- Upadacitinib Dose AExperimentalParticipants will receive upadacitinib dose A once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 1- PlaceboPlacebo comparatorParticipants will receive upadacitinib matching placebo once daily for 52 weeks.
Receives: Drug: Placebo
Study 2- Upadacitinib Dose AExperimentalParticipants will receive upadacitinib dose A once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 2- PlaceboPlacebo comparatorParticipants will receive upadacitinib matching placebo once daily for 52 weeks.
Receives: Drug: Placebo
Study 3- Low Disease Activity Upadacitinib (LDA) Dose AExperimentalParticipants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 3- Low Disease Activity Upadacitinib Dose BExperimentalParticipants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 3- No LDA Upadacitinib Dose AExperimentalParticipants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 3- Upadacitininb Dose AExperimentalParticipants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Receives: Drug: Upadacitinib
Study 3- Open Label Upadacitinib Dose AExperimentalParticipants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Receives: Drug: Upadacitinib
Study 3- Open Label Upadacitinib Dose BExperimentalParticipants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Receives: Drug: Upadacitinib
Study 4- Upadacitinib Dose AExperimentalParticipants receiving upadacitinib Dose A in Study 3 will continue on this dose once daily for 104 weeks.
Receives: Drug: Upadacitinib
Study 4- Upadacitinib Dose BExperimentalParticipants receiving upadacitinib Dose B in Study 3 will continue on this dose once daily for 104 weeks.
Receives: Drug: Upadacitinib

What is being measured

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

  1. Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response

    BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.

    Measured: At Week 52

Secondary outcomes (10)

  1. Percentage of Flares Participants Experiencing Over Time.

    Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year.

    Measured: Week 52

  2. Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4

    SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).

    Measured: At Week 52

  3. Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)

    LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score <= 4 excluding hSLEDAI activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA <= 1), and concomitant medication usage.

    Measured: At Week 52

  4. Time to First Flare per SELENA SLEDAI Flare Index (SFI)

    SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.

    Measured: Week 52

  5. Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent

    Achievement of oral glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.

    Measured: From Week 44 to Week 52

  6. Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints

    Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.

    Measured: Week 52

  7. Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score

    CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of >= 50% reduction in CLASI activity score among participants with baseline score >=10.

    Measured: Week 52

  8. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4

    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.

    Measured: Baseline to Week 52

  9. Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)

    The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.

    Measured: At Week 52

  10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)

    The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health.

    Measured: Baseline 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 posted6 May 2023
  2. Study start25 Jul 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionOct 2027 (estimated)

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05843643
Sponsor's protocol ID
M23-699
Other IDs
2023-503655-10-00, 2023
Acronym
SELECT-SLE
Status last verified
Apr 2026
First submitted
25 Apr 2023
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Systemic Lupus Erythematosus, run by AbbVie at 369 sites in 38 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 11 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 369 sites in United States, China, Japan, Argentina, Brazil and 33 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response (time frame: At 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 NCT05843643.

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 28 Apr 2026.

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