Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.

Last updated: February 6, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Musculoskeletal Diseases

Connective Tissue Diseases

Joint Injuries

Treatment

Tocilizumab

Upadacitinib

Clinical Study ID

NCT05609630
M14-682
2022-501599-25-00
  • Ages 1-17
  • All Genders

Study Summary

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to < 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions:

  • Must have active sJIA with at least 2 active joints at Screening and Baseline, fevermore than 38°C on at least one day within 14 consecutive days before the ScreeningVisit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactiveprotein (hsCRP) > upper limit of normal (ULN) at Screening. OR At least 4 activejoints at Screening and Baseline and an ESR or hsCRP > ULN at Screening.

  • Must have inadequate response to previous treatment with nonsteroidalanti-inflammatory drugs and/or systemic glucocorticoids, as judged by theinvestigator.

  • For Cohort 1, participants must not have had previous treatment with any IL-6inhibitor. For Cohort 2, participants must have an intolerance or inadequateresponse to an IL-6 inhibitor as judged by the investigator.

Note: For Cohort 1, participants must be ages 2 to < 18 years old in countries where SC tocilizumab is not approved for sJIA.

Exclusion

Exclusion Criteria:

  • Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined bythe ILAR criteria, and must not have a history or presence of any other autoimmuneinflammatory condition other than sJIA.

  • Has uncontrolled severe systemic disease and/or impeding or active macrophageactivation syndrome within 1 month prior to Baseline.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Tocilizumab
Phase: 3
Study Start date:
October 02, 2023
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • Instituto CAICI S.R.L /ID# 251448

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto CAICI S.R.L /ID# 251448

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Tucuman /ID# 251781

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman /ID# 251781

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 4000
    Argentina

    Active - Recruiting

  • Hospital de Niños de la Santisima Trinidad /ID# 252736

    Córdoba 3860259, 5014
    Argentina

    Active - Recruiting

  • Monash Children's Clinical Trials Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Children's Hospital /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Medical Centre /ID# 251691

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Royal Children's Hospital /ID# 251663

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Monash Health - Monash Medical Centre /ID# 251691

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Completed

  • Royal Children's Hospital /ID# 251663

    Parkville 2153770, Victoria 2145234 3052
    Australia

    Completed

  • Landeskrankenhaus Bregenz /ID# 266317

    Bregenz, Vorarlberg 6900
    Austria

    Site Not Available

  • Landeskrankenhaus Bregenz /ID# 266317

    Bregenz 2781503, Vorarlberg 2762300 6900
    Austria

    Active - Recruiting

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769

    Juiz de Fora, Minas Gerais 36010-570
    Brazil

    Site Not Available

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769

    Juiz de Fora 3459505, Minas Gerais 3457153 36010-570
    Brazil

    Completed

  • Hospital Sao Paulo /ID# 251765

    Sao Paulo, Tocantins 04023-062
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Hospital Sao Paulo /ID# 251765

    São Paulo 3448439, 04023-062
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Children's Hospital Affiliated to Chongqing Medical University /ID# 251539

    Chongqing, Chongqing 400014
    China

    Active - Recruiting

  • The Children's Hospital of Chongqing Medical University /ID# 251539

    Chongqing, Chongqing 400065
    China

    Site Not Available

  • The Childrens Hospital of Chongqing Medical University /ID# 251539

    Chongqing 1814906, Chongqing Municipality 1814905 400065
    China

    Active - Recruiting

  • Children's Hospital of Soochow University /ID# 251755

    Suzhou, Jiangsu 215025
    China

    Site Not Available

  • Children'S Hospital Of Soochow University /ID# 251755

    Suzhou 1886760, Jiangsu 1806260 215025
    China

    Active - Recruiting

  • Xi'an Children's Hospital /ID# 251693

    Xi'an, Shaanxi 710054
    China

    Site Not Available

  • Xi'an Children's Hospital /ID# 251693

    Xi'an 1790630, Shaanxi 1796480 710054
    China

    Active - Recruiting

  • Children's Hospital of Fudan University /ID# 251619

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Children's Hospital of Fudan University /ID# 251619

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Active - Recruiting

  • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Active - Recruiting

  • Universitaetsklinikum Freiburg /ID# 253288

    Freiburg, Baden-Wuerttemberg 79106
    Germany

    Site Not Available

  • Universitaetsklinikum Freiburg /ID# 253288

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
    Germany

    Active - Recruiting

  • Asklepios Klinik Sankt Augustin /ID# 251565

    Sankt Augustin, Nordrhein-Westfalen 53757
    Germany

    Site Not Available

  • St. Josef-Stift Sendenhorst /ID# 268680

    Sendenhorst, Nordrhein-Westfalen 48324
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin /ID# 251565

    Sankt Augustin 2841648, North Rhine-Westphalia 2861876 53757
    Germany

    Active - Recruiting

  • St. Josef-Stift Sendenhorst /ID# 268680

    Sendenhorst 2833076, North Rhine-Westphalia 2861876 48324
    Germany

    Active - Recruiting

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564

    Hamburg, 22081
    Germany

    Site Not Available

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564

    Hamburg 2911298, 22081
    Germany

    Active - Recruiting

  • Semmelweis Egyetem /ID# 266750

    Budapest, 1085
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 266750

    Budapest 3054643, 1085
    Hungary

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer /ID# 251775

    Florence, Firenze 50139
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer /ID# 251775

    Florence 3176959, Firenze 50139
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini /ID# 251776

    Genoa, Genova 16147
    Italy

    Site Not Available

  • IRCCS Istituto Giannina Gaslini /ID# 251776

    Genoa 3176219, Genova 16147
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini /ID# 251776

    Genova, L Aquila 16147
    Italy

    Site Not Available

  • Hyogo Prefectural Kobe Children's Hospital /ID# 251649

    Kobe-shi, Hyogo 650-0047
    Japan

    Site Not Available

  • Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649

    Kobe 1859171, Hyōgo 1862047 650-0045
    Japan

    Active - Recruiting

  • Hyogo Prefectural Kobe Children's Hospital /ID# 251649

    Kobe 1859171, Hyōgo 1862047 650-0047
    Japan

    Active - Recruiting

  • St. Marianna University Hospital /ID# 251623

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • St Marianna University School Of Medicine /ID# 251623

    Kawasaki-shi, Kanagawa 1860291 216-8511
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital /ID# 251538

    Niigata-shi, Niigata 951-8520
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital /ID# 251538

    Niigata 1855431, Niigata 1855429 951-8520
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital /ID# 252092

    Takatsuki-shi, Osaka 1853904 569-8686
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Hospital /ID# 251505

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital /ID# 251505

    Bunkyo-ku, Tokyo 1850144 113-8519
    Japan

    Active - Recruiting

  • CREA de Guadalajara SC /ID# 252917

    Guadalajara, Jalisco 44620
    Mexico

    Site Not Available

  • CREA de Guadalajara SC /ID# 252917

    Guadalajara 4005539, Jalisco 4004156 44620
    Mexico

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht /ID# 267435

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht /ID# 267435

    Utrecht 2745912, 3584 CX
    Netherlands

    Active - Recruiting

  • Hospital Sant Joan de Deu /ID# 251353

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu /ID# 251353

    Esplugues de Llobregat 3122826, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 251352

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 251352

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Queen Silvia Children's Hosp /ID# 251318

    Gothenburg, Vastra Gotalands Lan 416 85
    Sweden

    Site Not Available

  • Queen Silvia Children's Hosp /ID# 251318

    Gothenburg 2711537, Västra Götaland County 3337386 416 85
    Sweden

    Active - Recruiting

  • National Taiwan University Hospital /ID# 267387

    Taipei City, Taipei 7280290 100
    Taiwan

    Site Not Available

  • National Taiwan University Hospital /ID# 267387

    Taipei 1668341, 100
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267390

    Taoyuan 6696918, 333
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 267390

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Gazi University Medical Faculty /ID# 253677

    Ankara, 06560
    Turkey

    Site Not Available

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul University Istanbul Medical Faculty /ID# 251652

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 251651

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Umraniye Training and Res Hosp /ID# 251653

    Istanbul, 34764
    Turkey

    Site Not Available

  • Gazi University Medical Faculty /ID# 253677

    Ankara 323786, 06560
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul University Istanbul Medical Faculty /ID# 251652

    Istanbul 745044, 34093
    Turkey (Türkiye)

    Active - Recruiting

  • Umraniye Training and Res Hosp /ID# 251653

    Istanbul 745044, 34764
    Turkey (Türkiye)

    Active - Recruiting

  • Great Ormond Street Children's Hospital /ID# 251512

    London, Greater London WC1N 3HZ
    United Kingdom

    Site Not Available

  • Great Ormond Street Children's Hospital /ID# 251512

    London 2643743, Greater London WC1N 3HZ
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust /ID# 251512

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Phoenix Children's Hospital /ID# 253403

    Phoenix, Arizona 85016-7710
    United States

    Site Not Available

  • Phoenix Children's Hospital /ID# 253403

    Phoenix 5308655, Arizona 5551752 85016-7710
    United States

    Active - Recruiting

  • Childrens National Medical Center /ID# 253344

    Washington D.C. 4140963, District of Columbia 4138106 20010-2916
    United States

    Active - Recruiting

  • New York Medical College /ID# 253437

    Valhalla, New York 10595
    United States

    Site Not Available

  • New York Medical College /ID# 253437

    Valhalla 5142090, New York 5128638 10595
    United States

    Active - Recruiting

  • Levine Children's Hospital /ID# 253491

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Levine Children's Hospital /ID# 253491

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital Medical Center /ID# 251827

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center /ID# 251827

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Randall Children's Hospital /ID# 251829

    Portland, Oregon 97227-1654
    United States

    Site Not Available

  • Randall Children's Hospital /ID# 251829

    Portland 5746545, Oregon 5744337 97227-1654
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.