A MC study to assess Efficacy and Safety of Voclosporin in Pan-uveitis

• Research type

  Research Study

• Full title

  A Multi-centre, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Non-infectious Intermediate, Posterior or Pan-uveitis.

• IRAS ID

  66899

• Sponsor organisation

  Lux Biosciences,Inc.

• Eudract number

  2010-022128-63

• ISRCTN Number

  No number

• Clinicaltrials.gov Identifier

  No number

• Research summary

  The primary objective of this study is to assess the safety and efficacy of vaclosporin as therapy in subjects with active non-infectious uveitis involving the intermediate and /or posterior ocular segments. Subjects will be enrolled if they have confirmed or suspected infectious uveitis in either eye. Approximately 180 subjects will be recruited in the study from up to 50 sites globally. Subjects will be randomised in a 1:1 ratio to either vaclosporin or placebo which they will take twice a day. Suitable subjects will receive an information sheet and discuss the study with a researcher. The subject will sign the consent form with the investigator. If all the inclusion/exclusion criteria are fulfilled the subject will be randomised and remain in the study for 24 weeks. All subjects will be assessed at regular intervals during this period for efficacy and safety. Analyses - Analyses will be done on the intent-to-treat (ITT) population. - As supportive analysis to the ITT population, a per-protocol population will be used. Safety Monitoring - A Data Monitoring Committee (DMC) will monitor safety according to the DMC Charter. - The DMC will communicate recommendations for changes to the study conduct or oversight to the Sponsor.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/62

• Date of REC Opinion

  1 Apr 2011

• REC opinion

  Further Information Favourable Opinion