Phase 3 Uveitis Trial, Terminated NCT01095250 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 enrolled 31 people in total across four groups: 8 people received AIN457 (secukinumab) at 300 mg every 2 weeks, 10 received 300 mg every 4 weeks, 8 received 150 mg every 4 weeks, and 5 received a placebo (an inactive injection). The trial was designed to test whether AIN457, given as an injection under the skin, could reduce eye inflammation in people with a condition called non-infectious uveitis — specifically those with Behçet's disease. The main thing researchers planned to measure was the change in a score describing cloudiness inside the eye (called "vitreous haze") from the start of the trial to 28 weeks. The reported data shows that no outcome measure numbers — for either the primary measure or any of the six secondary measures (such as changes in vision, quality of life, or eye inflammation scores) — were provided. According to the results reported on ClinicalTrials.gov, none of the participants reached the point in the study where the main measurement was due to be taken. As a result, the trial was stopped early because of what the sponsor described as a low likelihood of the study achieving a meaningful result. Because participants did not reach the required stage of the trial, the sponsor stated that no meaningful data could be reported for any of the planned outcome measures. The reported data therefore contains no numerical results for any of the outcomes that were originally planned to be measured. All 31 participants who started the trial are recorded as not having completed it, and the reasons relate to the early termination of the study rather than individual dropouts. No outcome figures are available in the submitted results. 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, Terminated

NCT01095250
Terminated 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 are 18 years of age or older (male or female)
  • You have been diagnosed with a long-term, non-infectious eye inflammation condition affecting the middle, back, or entire layer of at least one eye
  • Your eye inflammation is currently active and at a moderate or higher level in at least one eye
  • You have needed strong immune-suppressing treatments for your eye condition, such as steroid tablets (prednisone 10mg or more daily) in the past 3 months, steroid injections around or into the eye in the past 6 months, or medications like cyclosporine, methotrexate, or mycophenolate in the past 3 months
  • If you have not used those immune-suppressing treatments, you may still qualify if your doctor confirms you were unable to tolerate them
  • You are able to understand the study requirements and are willing to sign a consent form

Who may not be able to join:

  • You need very high doses of steroid medication (1.5 mg per kg of body weight per day or more) to control your eye inflammation
  • Your primary diagnosis is Behcet's disease, front-of-eye inflammation only, or a type of eye inflammation that tends to go away on its own or does not involve certain types of eye inflammation activity (confirm with trial site)
  • Your eye inflammation is caused by an infection, or the cause is unclear and might be something where immune-suppressing treatment could be harmful (such as eye lymphoma)
  • You have had anti-VEGF injections into the study eye in the past 3 months
  • You have had a long-term steroid implant (fluocinolone acetonide) in the study eye in the past 3 years, or a dexamethasone implant in the past 6 months
  • You have had eye surgery or laser treatment in the study eye within the past 6 weeks (minor diagnostic procedures may be exceptions — confirm with trial site)
  • You have an eye condition that could interfere with assessing the treatment, such as severe cataracts, uncontrolled glaucoma, or scarring
  • You are currently taking or are likely to need medications known to be harmful to the eye's lens, retina, or optic nerve
  • You have previously received the study drug (AIN457)
  • You have received any biological therapy (such as infliximab, adalimumab, or etanercept) by injection or infusion within the past 3 months
  • You have been treated with powerful immune-suppressing chemotherapy drugs (cyclophosphamide or chlorambucil) within the past 5 years
  • You have received a live vaccine (such as chickenpox or measles vaccines) within the past 2 months

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
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 April 2010
Est. completion
1 October 2010

Where this trial is recruiting

🇨🇦 Canada 🇪🇬 Egypt 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇯🇵 Japan 🇸🇬 Singapore 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.

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