Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

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. Following the approval of Amendment 2, only patients with active disease” as defined above will be enrolled in the study.
Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than 80 mg/day.
At screening, patients must be receiving oral prednisone (=15 mg and < 80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with Methotrexate (MTX) (= 25 mg/week) orally or intravenously or intra muscular or subcutaneous). Patients can be receiving one or several of the following therapies: Azathioprine (=2.5 mg/kg/day), Mycophenolate mofetil (=2g daily, orally), Cyclosporine (=4 mg/kg daily, orally), Tacrolimus (=4 mg daily, orally).
The doses may not have been increased for at least 4 weeks prior to the randomization visit.
At randomization, patients have been receiving oral prednisone (=15 mg and < 80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with methotrexate (MTX) (= 25 mg/week) orally or intravenously or intra muscular or subcutaneous).
Azathioprine, mycophenolate mofetil, cyclosporine and tacrolimus have to be permanently discontinued at least 48 hours prior to the first study treatment injection, or longer as per Investigator’s judgment. These IMTs are not permitted anytime during the treatment period.
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 macular edema.<br>To evaluate the change in other signs of ocular inflammation. <br>To evaluate the effect on retinal vessel leakage. <br>To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy at W16.<br>To evaluate the change in ocular inflammation in the anterior chamber. <br>To evaluate the pharmacokinetics of sarilumab in NIU patients.<br>To evaluate the immunogenicity with anti-drug antibodies (ADA)<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) Mean change from baseline in VH <br>2) 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>3) Mean change from baseline in BCVA (ETDRS letters score)<br>4) Mean change from baseline in central retinal thickness measured with Optical Coherence Tomography (OCT)<br>5) Percentage of patients with Central Retinal Thickness <300 microns <br>6) Percentage of patients without retinal vessel leakage on fluorescein angiography<br>7) Percentage of patients with dose of prednisone = 5mg/day (or equivalent oral corticosteroid) <br>8) Pharmacokinetics assessment<br>9) Adverse events including Serious Adverse Events and Adverse Events of Special Interest<br>10) Assessment of clinical laboratory data;Timepoint(s) of evaluation of this end point: 1) to 10): At 16 weeks<br>

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