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NCT Number: NCT04088409

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Uveitis Eye Diseases Uveal Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre, Le Kremlin-Bicêtre, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
  • Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
  • Participants must have an inadequate response or intolerance to MTX.
  • Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
  • Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.

Exclusion criteria

  • Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
  • Participants must not have any contraindications to adalimumab.
  • Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
  • Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
  • Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
  • Participants must not have a current or recent (<4 weeks prior to baseline) infection.
  • Participants must not have a positive test for hepatitis B virus (HBV) at screening.
  • Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104

Adalimumab

Drug

Administered SC

Primary outcomes

  1. Part A: Percentage of Responders for Baricitinib at Week 24

    Time frame: Week 24

    Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.

Secondary outcomes

  1. Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

    Time frame: Baseline, Week 24

    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed.

  2. Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)

    Time frame: Baseline, Week 24

    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed.

  3. Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline

    Time frame: Week 24

    Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. Outcome data will be provided after the study is completed.

  4. Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test

    Time frame: Baseline, Week 24

    Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.

  5. Change From Baseline in Vitreous Haze

    Time frame: Baseline, Week 24

    Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.

  6. Change From Baseline in Grade of Flare in the Anterior Chamber

    Time frame: Baseline, Week 24

    Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.

  7. Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)

    Time frame: Week 24

    Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.

  8. Time to Inactive Anterior Uveitis Disease (Using SUN Definition)

    Time frame: Baseline through Week 24

    Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.

  9. Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

    Time frame: Week 24

    Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day. Outcome data will be provided after the study is completed.

  10. Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)

    Time frame: Week 24

    PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.

  11. Change From Baseline in Overall Uveitis-Related Disability

    Time frame: Baseline, Week 24

    Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Sep 12, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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