NCT01243983

Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Lux Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).

Conditions

• Noninfectious Uveitis

Interventions

Type	Name	Description
DRUG	LX211	Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio: * Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d. * Treatment Arm B: placebo p.o. b.i.d. Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-11-19
• Last updated: 2013-01-10

Locations

52 sites across 9 countries: United States, Austria, Brazil, Canada, Czechia, France, Germany, Italy, United Kingdom