Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis — SARILNIUSATURN  

Uveitis Clinical Trial

Official title: A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU)

Status Completed

Clinical Trial Summary

Primary Objective:

To evaluate the efficacy of sarilumab at week 16 in patients with non-infectious uveitis (NIU).

Secondary Objectives:

To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in patients with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy.

To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU patients. To evaluate the immunogenicity with anti-drug antibodies (ADA).

Clinical Trial Description

The total duration per patient is up to 58 weeks, which includes a 2 week screening period, 16 weeks principal treatment period, 34 weeks extension treatment period (or open label treatment period), and 6 weeks after last treatment administration.

Non-responder patients, observed within the first 16 weeks, will be offered to be treated by open-label sarilumab. Patients will be treated for 34 extra weeks (up to 18 extra injections). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

• NCT number: NCT01900431
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Completion date: April 2016