Phase 2 Uveitis Trial, Completed NCT01900431 Sponsor: Sanofi 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 looked at a medicine called sarilumab (given as an injection every two weeks) compared to a placebo (an inactive injection) in people with a condition affecting the eye called uveitis — specifically a type involving cloudiness inside the eye. A total of 20 people started in the placebo group and 38 in the sarilumab group during the main part of the trial (Part A, running to Week 16). A separate open-label phase (Part C), where 21 participants received sarilumab without a comparison group, was also conducted. The trial was primarily measuring how many participants showed a meaningful reduction in eye cloudiness (called vitreous haze) or were able to reduce their steroid tablet dose below a certain level by Week 16. The reported data shows that in the main treatment period, 30.0% of participants in the placebo group and 46.1% in the sarilumab group met the primary goal of either a meaningful reduction in eye cloudiness or a lower steroid dose by Week 16. For the secondary measurements, the reported data shows that eye cloudiness scores changed by an average of −0.1 points (placebo) and −0.9 points (sarilumab) on a 9-step scale. A vision test score (measuring how many letters a person could read on a standardised chart) changed on average by +3.5 letters in the placebo group and +9.3 letters in the sarilumab group — where a higher number means more letters read. The thickness of the central part of the retina (a layer at the back of the eye) changed by an average of −8.9 microns in the placebo group and −35.4 microns (about −6.4%) in the sarilumab group. For a measure of cell activity at the front of the eye, 86.7% of the placebo group and 86.2% of the sarilumab group met the target response — nearly identical figures across both groups. 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

NCT01900431
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 must be 18 years of age or older.
  • You have a non-infectious type of eye inflammation (uveitis) affecting the middle, back, or entire part of the eye.
  • Your eye condition was active at the time of screening, or showed signs of activity within the 3 months before your screening visit.
  • You are currently taking oral prednisone (a steroid tablet) at a dose of at least 15 mg per day but less than 80 mg per day, either alone or alongside a medication called methotrexate.
  • You may also be taking certain other immune-suppressing medications at specific doses, such as azathioprine, mycophenolate mofetil, cyclosporine, or tacrolimus (confirm with trial site).
  • Your medication doses must not have been increased in the 4 weeks before joining the trial.
  • You have read and signed a consent form agreeing to take part.

Who may not be able to join:

  • Your best corrected vision (even with glasses or lenses) is very poor — below a certain level — in at least one eye (confirm with trial site).
  • Your eye inflammation is caused by an infection or a physical injury.
  • Your main diagnosis is inflammation at the front of the eye only (anterior uveitis).
  • You have previously been treated with certain specific medications that target a protein called IL-6 or its receptor, including tocilizumab or sarilumab.

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
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2013
Est. completion
1 July 2015

Where this trial is recruiting

🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇪🇸 Spain Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16

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