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New pill could ease severe childhood arthritis

NCT ID NCT05609630

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 8 times

Summary

This study tests a new oral medication, upadacitinib, in children aged 1 to 17 with active systemic juvenile idiopathic arthritis (sJIA), a rare and serious form of arthritis that can affect the whole body. About 90 participants will receive either upadacitinib or the standard injectable drug tocilizumab for 52 weeks. Researchers will measure how well the treatment controls symptoms like joint pain and fever, and monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (oral tablet or solution)
What this could lead to
If it works, this could provide a new oral treatment option for children with systemic juvenile idiopathic arthritis, potentially reducing symptoms and improving daily life.
What could go wrong
This is a Phase 3 trial, but upadacitinib is still investigational for this condition. It may not prove more effective than existing treatments, and side effects like infections or allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, fever more than 38°C on at least one day within 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP \> ULN at Screening. * Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the investigator. * For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response 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 Criteria: * Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA. * Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis systemic-onset juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile idiopathic arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik Sankt Augustin /ID# 251565

    RECRUITING

    Sankt Augustin, North Rhine-Westphalia, 53757, Germany

  • Azienda Ospedaliero Universitaria Meyer /ID# 251775

    RECRUITING

    Florence, Firenze, 50139, Italy

  • Boston Childrens Health Physicians /ID# 253437

    RECRUITING

    Valhalla, New York, 10595, United States

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

    COMPLETED

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

  • CREA de Guadalajara SC /ID# 252917

    RECRUITING

    Guadalajara, Jalisco, 44620, Mexico

  • Centro de Investigaciones Medicas Tucuman /ID# 251781

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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

    RECRUITING

    Suzhou, Jiangsu, 215025, China

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

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Childrens National Medical Center /ID# 253344

    RECRUITING

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

  • Cincinnati Childrens Hospital Medical Center /ID# 251827

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Gazi University Medical Faculty /ID# 253677

    COMPLETED

    Ankara, 06560, Turkey (Türkiye)

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

    RECRUITING

    London, Greater London, WC1N 3HZ, United Kingdom

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

    RECRUITING

    Hamburg, 22081, Germany

  • Helios Klinikum Berlin - Buch /ID# 279847

    RECRUITING

    Berlin, 13125, Germany

  • Hospital Sant Joan de Deu /ID# 251353

    RECRUITING

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Sao Paulo /ID# 251765

    RECRUITING

    São Paulo, 04023-062, Brazil

  • Hospital Universitario y Politecnico La Fe /ID# 251352

    RECRUITING

    Valencia, 46026, Spain

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

    RECRUITING

    São Paulo, 05403-000, Brazil

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

    RECRUITING

    Córdoba, 5014, Argentina

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

    RECRUITING

    Kobe, Hyōgo, 650-0045, Japan

  • IRCCS Istituto Giannina Gaslini /ID# 251776

    RECRUITING

    Genoa, Genova, 16147, Italy

  • Institute of Science Tokyo Hospital /ID# 251505

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Instituto CAICI S.R.L /ID# 251448

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

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

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul University Istanbul Medical Faculty /ID# 251652

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Landeskrankenhaus Bregenz /ID# 266317

    RECRUITING

    Bregenz, Vorarlberg, 6900, Austria

  • Levine Children's Hospital /ID# 253491

    COMPLETED

    Charlotte, North Carolina, 28203, United States

  • Linkou Chang Gung Memorial Hospital /ID# 267390

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Monash Health - Monash Medical Centre - Clayton /ID# 251691

    COMPLETED

    Clayton, Victoria, 3168, Australia

  • National Taiwan University Hospital /ID# 267387

    RECRUITING

    Taipei, 100, Taiwan

  • Niigata University Medical and Dental Hospital /ID# 251538

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

  • Osaka Medical and Pharmaceutical University Hospital /ID# 252092

    RECRUITING

    Takatsuki-shi, Osaka, 569-8686, Japan

  • Phoenix Children's Hospital /ID# 253403

    RECRUITING

    Phoenix, Arizona, 85016-7710, United States

  • Queen Silvia Children's Hosp /ID# 251318

    RECRUITING

    Gothenburg, Västra Götaland County, 416 85, Sweden

  • Randall Children's Hospital /ID# 251829

    RECRUITING

    Portland, Oregon, 97227-1654, United States

  • Royal Children's Hospital /ID# 251663

    COMPLETED

    Parkville, Victoria, 3052, Australia

  • Semmelweis Egyetem /ID# 266750

    RECRUITING

    Budapest, 1085, Hungary

  • St Marianna University School Of Medicine /ID# 251623

    RECRUITING

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • St. Josef-Stift Sendenhorst /ID# 268680

    RECRUITING

    Sendenhorst, North Rhine-Westphalia, 48324, Germany

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

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

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

    RECRUITING

    Chongqing, Chongqing Municipality, 400065, China

  • Umraniye Training and Res Hosp /ID# 251653

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

  • Universitaetsklinikum Freiburg /ID# 253288

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitair Medisch Centrum Utrecht /ID# 267435

    RECRUITING

    Utrecht, 3584 CX, Netherlands

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

    RECRUITING

    Xi'an, Shaanxi, 710054, China

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Other studies related to the condition(s) this trial covers.