Phase 3 Uveitis Trial, Completed NCT00995709 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 118 people in total — 39 received the study drug (called AIN457C, also known as secukinumab) every two weeks, 40 received it once a month, and 39 received a dummy (placebo) treatment. The trial ran for 24 weeks and was looking at a condition called Behçet's disease, which can cause repeated flare-ups of inflammation at the back of the eye. The main thing the trial measured was how often those eye flare-ups happened during the 24-week period. It also looked at secondary measures including steroid medication use, retinal thickness (a scan measuring the layers at the back of the eye), quality of life, and overall disease activity. Not all participants finished the study — 32, 31, and 34 completed it in the three groups respectively. The reported data shows that for the primary outcome — the rate of eye flare-ups over 24 weeks — the every-two-weeks group and the placebo group both recorded a rate of 7.7 flare-ups, while the monthly group recorded a rate of 11.5. In terms of how many participants experienced flare-ups, the numbers were broadly similar across all three groups. For the secondary outcomes, the reported data shows changes in steroid medication scores, retinal thickness scans, and disease activity scores across all groups. For retinal thickness (measured in micrometres), the every-two-weeks group showed an average reduction of 26.5, the monthly group showed a small increase of 3.6, and the placebo group showed a reduction of 49.4. For overall Behçet's disease activity, small reductions from baseline were recorded in all three groups (−1.3, −1.7, and −1.1 respectively). Quality of life scores and steroid use data were also reported across the groups, though interpreting what those differences mean in a clinical sense was not described in the submitted 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, Completed

NCT00995709
Completed 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 Behçet's disease and have had repeated episodes of eye inflammation (uveitis) in at least one eye.
  • You have had more than 2 flare-ups of moderate-to-severe eye inflammation (affecting the middle or back of the eye, or the whole eye) in the past 6 months, with documented evidence of this in your medical records.
  • Your flare-ups involved specific signs such as significant cloudiness inside the eye, damage to the retina or its blood vessels, or a noticeable drop in vision caused by the inflammation.
  • You have needed strong anti-inflammatory treatments for at least 3 of the past 6 months, such as steroid tablets (prednisone over 10mg daily), steroid injections into or around the eye, or certain other immune-suppressing medications (such as cyclosporine, azathioprine, methotrexate, or similar drugs).
  • You may also be eligible if you are unable to tolerate immune-suppressing treatments, as determined by the trial doctor.

Who may not be able to join:

  • You have uveitis caused by an infection, a condition other than Behçet's disease, or an unknown cause.
  • Your eye inflammation only affects the front of the eye (anterior uveitis).
  • You have received certain injected eye treatments (anti-VEGF injections) in the study eye within the past 3 months.
  • You have had a slow-release steroid implant placed in the study eye within the past 3 years.
  • You have had eye surgery or laser treatment in the study eye within the past 6 weeks (minor diagnostic procedures may be acceptable — confirm with trial site).
  • You have received a live vaccine (such as chickenpox or measles) within the past 2 months.
  • You have received certain biological therapies (such as infliximab, adalimumab, or interferon) by injection or infusion within the past 3 months, or have previously been treated with a drug called AIN457.
  • You have ever been treated with strong chemotherapy-type drugs such as cyclophosphamide or chlorambucil.
  • There may be additional criteria not listed here (confirm with trial site).

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
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 October 2009
Est. completion
1 July 2010

Where this trial is recruiting

🇪🇬 Egypt 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇴 Jordan 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Tunisia Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment; Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment

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