Placebo-controlled study of AIN457 in quiescent uveitis (ENDURE)

• Research type

  Research Study

• Full title

  A 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis (ENDURE Study)

• IRAS ID

  37222

• Contact name

  aaron osborne

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-014835-19

• ISRCTN Number

  not available

• Research summary

  Non-infectious uveitis (inflammation of the eye) is characterised by recurrent flare-ups of inflammation in one or both eyes, which can lead to damage to the eye resulting in loss of vision or blindness. Corticosteroids are commonly used in the treatment of uveitis, but these treatments are not effectve in all cases, and can have side effects, particularly if used at high doses over long periods of time. Interleukin-1?A (IL-17A) is a cytokine which is believed to be partly responsible for causing inflammation in the body, and levels have been found to be raised in the blood of some patients with uveitis. AIN457 is a human monoclonal antibody, which binds to IL-17A and thereby reduces its activity. The aim of this study is to determine whether AIN457 is an effective and safe treatment in patients with non-active, non-infectious uveitis, and to see if their disease can be controlled by AIN457 when their usual medication is gradually withdrawn. Eligible patients who have provided written agreement to take part in the study will be randomly allocated to receive subcutaneous injections of three different doses of AIN457 or placebo on 13 occasions over a 24-week study period, in addition to their usual prescribed treatment for uveitis. There will be a 1 in 4 chance of receiving placebo, but neither the doctor nor the patient will know which treatment has been allocated. Patients will visit the hospital clinic 15 times in total over the 24-week period, and the main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography, measurement of intraocular pressure, physical examinations, blood pressure, pulse, temperature, breathing rate, blood tests and completion of health-related questionnaires. Around 232 patients will be recruited worldwide into this study, of which 36 will be from the UK.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/3

• Date of REC Opinion

  26 Mar 2010

• REC opinion

  Further Information Favourable Opinion