NCT01032915

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

A 24 Week Multi-center, 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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

Conditions

• Non-infectious Uveitis

Interventions

Type	Name	Description
BIOLOGICAL	AIN457	AIN457 300mg s.c weekly for 3 weeks then every 2 weeks
BIOLOGICAL	AIN457	AIN457 300mg s.c at baseline and Week 2 then every 4 weeks
BIOLOGICAL	AIN457	AIN457 150mg s.c at baseline and Week 2 then every 4 weeks
DRUG	Placebo	Placebo s.c weekly for 3 weeks then every 2 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-12-16
• Last updated: 2015-11-05
• Results posted: 2015-11-05

Locations

94 sites across 10 countries: United States, Brazil, Germany, India, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom