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Active, not recruiting Phase 3

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

NCT04088409 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2019-10-16
Last updated
2026-04-24

Condition(s) studied

Uveitis

Investigational drug(s) / intervention(s)

Baricitinib →Adalimumab →

Baricitinib: Administered orally

Adalimumab: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (20)

FacilityCityRegionStatus
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin-Bicêtre France
Hôpital Universitaire Necker Enfants Malades Paris France
Centre Hospitalier Universitaire de Poitiers Poitiers France
Asklepios Klinik Sankt Augustin Sankt Augustin North Rhine-Westphalia
HELIOS Klinikum Berlin-Buch Berlin Germany
Charité Campus Virchow-Klinikum Berlin Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari Hamburg Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Lombardy
Azienda Ospedaliero Universitaria Meyer Florence Italy
Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona
Hospital Infantil Universitario Niño Jesús Madrid Madrid, Comunidad de
Hospital Universitario La Paz Madrid Madrid, Comunidad de
Hospital Universitario La Fe de Valencia Valencia Spain
Bristol Royal Hospital for Children Bristol Bristol, City of
Cambridge Clinical Research Facility Cambridge Cambridgeshire
Alder Hey Children's Hospital Liverpool England
Royal Victoria Infirmary Newcastle upon Tyne England
University Hospital Southampton NHS Foundation Trust Southampton Hampshire
Great Ormond Street Hospital For Children NHS Foundation Trust London United Kingdom
Sheffield Children's Hospital Sheffield United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04088409 on ClinicalTrials.gov ↗ ← All trials in Italy