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

Phase 3 Terminated 125 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2010-02
Primary completion: 2011-06
Completion: 2011-06

Outcome

Missed primary endpoint

Stopped: “Results of a planned interim analysis did not show significant effects for any of the 3 AIN dose regimens versus placebo on any primary or secondary endpoint”

paper The primary efficacy end points of the 3 studies were not met. PMID 23290985 ↗

Publications

Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous