Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

Phase 1

Conditions: veitis
MedDRA version: 17.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2012-004845-34-DE

Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

=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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of sarilumab at week 16 in patients with non-infectious uveitis (NIU).;Secondary Objective: To evaluate the change in best corrected visual acuity (BCVA).<br>To evaluate the safety of subcutaneous sarilumab in patients with NIU.<br>To evaluate the change in other signs of ocular inflammation.<br>;Primary end point(s): Percentage of patients with at least 2-step reduction in Vitreous Haze OR dose of prednisone < 10 mg/day;Timepoint(s) of evaluation of this end point: At 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percentage of patients with anterior chamber score = 0 or at least 2-step reduction in score (Tyndall and flare according to the SUN classification) <br>2) Mean change from baseline in BCVA (ETDRS letters score)<br>3) Number of patients experiencing adverse events;Timepoint(s) of evaluation of this end point: 1/2) At 16 weeks<br>3) Up to 16 weeks