Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

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) - SARILNIUSATURN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004845-34-CZ

Enrollment

Registered

2013-06-17

Start date

2013-09-02

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis MedDRA version: 17.1 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab CAS Number: 1189541-98-7 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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). 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 at W16. 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) ;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	—

Measure

Time frame

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). 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 at W16. 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) ;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

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Secondary

Measure	Time frame
Secondary end point(s): 1) Mean change from baseline in VH 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) 3) Mean change from baseline in BCVA (ETDRS letters score) 4) Mean change from baseline in central retinal thickness measured with Optical Coherence Tomography (OCT) 5) Percentage of patients with Central Retinal Thickness <300 microns 6) Percentage of patients without retinal vessel leakage on fluorescein angiography 7) Percentage of patients with dose of prednisone = 5mg/day (or equivalent oral corticosteroid) 8) Pharmacokinetics assessment 9) Adverse events including Serious Adverse Events and Adverse Events of Special Interest 10) Assessment of clinical laboratory data;Timepoint(s) of evaluation of this end point: 1) to 10): At 16 weeks	—

Measure

Time frame

Secondary end point(s): 1) Mean change from baseline in VH 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) 3) Mean change from baseline in BCVA (ETDRS letters score) 4) Mean change from baseline in central retinal thickness measured with Optical Coherence Tomography (OCT) 5) Percentage of patients with Central Retinal Thickness <300 microns 6) Percentage of patients without retinal vessel leakage on fluorescein angiography 7) Percentage of patients with dose of prednisone = 5mg/day (or equivalent oral corticosteroid) 8) Pharmacokinetics assessment 9) Adverse events including Serious Adverse Events and Adverse Events of Special Interest 10) Assessment of clinical laboratory data;Timepoint(s) of evaluation of this end point: 1) to 10): At 16 weeks

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Countries

Czech Republic, France, Germany, Italy, Spain, Switzerland, Turkey, United States

Contacts

Public Contactwww.sanofi.cz

sanofi-aventis, s.r.o.

cz-info@sanofi.com+420233 08 61 11

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026