Recruiting
Phase 3

Upadacitinib & Tocilizumab

Sponsor:

AbbVie

Code:

NCT05609630

Conditions

Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Tocilizumab

Study Details

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Study ID

NCT05609630

Start date

Oct 2, 2023

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 Upadacitinib

Participants will receive upadacitinib for 52 weeks.

active comparator: Cohort 1 Tocilizumab

Participants will receive tocilizumab for 52 weeks.

experimental: Cohort 2 Upadacitinib

Participants will receive upadacitinib for 52 weeks.

Interventions

Upadacitinib

Oral tablet or Oral solution

Tocilizumab

Subcutaneous injection or Intravenous infusion

Primary outcome measure

  • Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response [ Time Frame: At Week 12 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Week 52 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Phoenix Children's Hospital /ID# 253403

Recruiting

Phoenix, Arizona, United States, 85016-7710

Contacts

Site Coordinator

602-933-3822sgorry@phoenixchildrens.com

Childrens National Medical Center /ID# 253344

Recruiting

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

New York Medical College /ID# 253437

Recruiting

Valhalla, New York, United States, 10595

Contacts

Site Coordinator

914-504-0152

Cincinnati Childrens Hospital Medical Center /ID# 251827

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Site Coordinator

1-513-636-3644megan.quinlan-waters@cchmc.org

Randall Children's Hospital /ID# 251829

Recruiting

Portland, Oregon, United States, 97227-1654

Contacts

Site Coordinator

1-503-413-3508bbogle@lhs.org

More Information

Sponsor

AbbVie

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Systemic Juvenile Idiopathic Arthritis
  • sJIA
  • Upadacitinib
  • ABT-494

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-14.