At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Sarilumab, Prednisone, and 3 other interventions for Uveitis. Completed, enrolled 58 participants across 20 sites in 6 countries.
Detailed Summary
Primary Objective: To evaluate the efficacy of sarilumab at Week 16 in participants 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 participants 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 participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).
Study Details
Timeline
Interventions
Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
Pharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular
Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous