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New hope for kids with eye inflammation: baricitinib trial shows promise

NCT ID NCT04088409

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether baricitinib, an oral drug, is safe and effective for children aged 2 to 18 with active uveitis (eye inflammation) linked to juvenile arthritis or a related condition. Participants had not responded well to standard treatments. The main goal is to reduce eye inflammation, with results expected to show if baricitinib can help control the disease.

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

30 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Jul 2028

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

2 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: * 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.

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Conditions

The condition(s) this trial relates to.

uveitis

As listed by the trial registrant

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

Uveitis

Contacts and locations

Locations

  • Alder Hey Children's Hospital

    Liverpool, England, L14 5AB, United Kingdom

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, North Rhine-Westphalia, 53757, Germany

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50100, Italy

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City of, BS2 8BJ, United Kingdom

  • Cambridge Clinical Research Facility

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Charité Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015, France

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

    Hamburg, 22081, Germany

  • Royal Victoria Infirmary

    Newcastle upon Tyne, England, NE1 4LP, United Kingdom

  • Sheffield Children's Hospital

    Sheffield, S10 2TH, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 0YD, United Kingdom

More trials for these conditions

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