Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

Phase 1

• Conditions: veitis; MedDRA version: 16.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-004845-34-ES
• Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

sup or equal 18 years of age.
Non-infectious intermediate-, posterior-, or pan-uveitis in the study eye.
Active disease at screening or evidence of activity within the 3 months prior to screening visit.
On stable dose of prednisone or equivalent steroid compound for at least 4 weeks prior to randomization.
Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Patient with best-corrected visual acuity worse than 20 ETDRS letters in at least one eye.
Patient with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic etiology.
Patient with primary diagnosis of anterior uveitis.
Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab and sarilumab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified