Phase 2 Uveitis Trial, Completed NCT00685399 Sponsor: Novartis Pharmaceuticals 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 involved participants across eight groups (called cohorts or arms), who were tested at different stages — a Treatment Period 1, a Treatment Period 2, and an Extension phase. In Treatment Period 1, 16 people started and 10 completed that phase. In Treatment Period 2, a total of 60 people started across six groups, with varying numbers completing. In the Extension phase, 28 people started and 21 completed. The trial was measuring the safety profile of the study drug (AIN457, also known as secukinumab) in people with uveitis (inflammation inside the eye), as well as looking at how many participants showed a meaningful improvement in their eye condition. The reported data shows that for the primary outcome — counting the number of participants who experienced unwanted health events (called adverse events), serious unwanted health events, or death — small numbers were recorded across the groups: one participant each in Cohort 3, Cohort 5, and Cohort 2 experienced adverse events, while no deaths were reported in the data provided. For the secondary outcomes, the reported data shows that a small number of participants across certain groups met the definition of a "responder" (meaning they showed at least one meaningful improvement in vision, eye inflammation, or were able to reduce their steroid medication) at Day 57: for example, one responder each was reported in Cohorts 2, 6 Arm 1, and 6 Arm 2, and three in Cohort 6 Arm 3. Similarly, small numbers of "complete responders" (those who were able to stop all steroid medications and maintain improvement) were reported across some groups. The reported data also notes that several other planned secondary outcomes — including measuring reductions in steroid use and rates of remission — were not formally analysed and no summary numbers were provided. According to the results reported on ClinicalTrials.gov, this was because the overall number of participants was too small and initial drug doses were too low to draw meaningful conclusions about how the dose related to outcomes. 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 2 Uveitis Trial, Completed

NCT00685399
Completed Phase 2

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 active uveitis (an inflammatory eye condition that is currently flaring up, not in remission).
  • Your uveitis affects the middle, back, or the whole of the eye, and is severe enough that your doctor has determined you need medication that affects your whole immune system.

Who may not be able to join:

  • You currently have an active infection of any kind.
  • You weigh more than 120 kilograms (approximately 265 pounds).

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 2: approximately ~30% 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
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 June 2008
Est. completion
1 September 2013

Where this trial is recruiting

🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died

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