Phase 3 Uveitis Trial, Active, Not Recruiting NCT04088409 Sponsor: Eli Lilly and Company Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04088409) looked at two medicines — baricitinib and adalimumab — in children and young people with a condition causing inflammation inside the eye (uveitis). In the first part of the trial (Part A), 25 participants were assigned to baricitinib and 5 to adalimumab. Of those, 24 and 5 respectively received at least one dose. The trial was primarily measuring how many participants showed a meaningful reduction in eye inflammation by week 24, using a recognised grading system called the SUN criteria, which looks at the level of inflammatory cells in the front part of the eye. The reported data shows that, in the baricitinib group, 33.3% of participants met the definition of a "responder" at week 24 — meaning roughly one in three showed the required reduction in eye inflammation according to the SUN criteria. No equivalent figure was reported for the adalimumab group, which had very small numbers. For all of the secondary outcome measures — including changes in eye inflammation scores, vision test results, and a measure called vitreous haze (cloudiness inside the eye) — the reported data states that results would be provided after the study was completed, meaning those figures were not available in the submitted results. It is also worth noting that the trial had two parts: in Part B, 10 participants from the baricitinib group started but none completed, and no secondary outcome data was reported for this stage either. The reasons participants did not complete each part were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Uveitis Trial, Active, Not Recruiting

NCT04088409
Active, Not Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a type of eye inflammation linked to juvenile idiopathic arthritis (JIA-U) or a long-term eye condition called chronic anterior uveitis that tested positive for a certain antibody (ANA), without other body-wide symptoms.
  • You currently have active eye inflammation in the front part of your eye, at a certain level of severity, even after being treated with steroid eye drops and a medication called methotrexate (MTX).
  • Your body has not responded well enough to methotrexate, or you were not able to tolerate it.
  • You have been using steroid eye drops at a steady dose for at least 2 weeks before the start of the study, using no more than 4 drops per day per eye.
  • You and any partner who could become pregnant must agree to use 2 reliable forms of contraception throughout the study and for at least 1 week after the last dose of the study medication.

Who may not be able to join:

  • You have, or have had, another autoimmune condition (such as Crohn's disease or ulcerative colitis) in addition to JIA.
  • You have a medical reason that prevents you from safely taking the medication adalimumab — though there is an exception if you previously did not respond to or could not tolerate certain biological medications, in which case you may still be considered for the trial (confirm with trial site).
  • You have had high eye pressure (25 mmHg or above), or needed treatment for eye pressure problems — including extra medication, surgery, or a hospital stay — within 4 weeks before the study starts.
  • You have had eye surgery (such as for cataracts, glaucoma, or a procedure inside the eye) within the 3 months before the study screening.
  • You currently have, or recently had (within 4 weeks before the study starts), an infection of any kind.
  • Your blood test showed a positive result for hepatitis B at the time of screening.
  • You have signs of active tuberculosis (TB), or you have latent (inactive) TB that has not been treated.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
16 October 2019
Est. completion
17 July 2023

Where this trial is recruiting

🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Part A: Percentage of Responders for Baricitinib at Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov