Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
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).
Timeline
- Start
- 2013-10
- Primary completion
- 2015-07
- Completion
- 2016-04
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo (Part A) vs Sarilumab 200 mg q2w (Part A); p = 0.2354 NCT01900431 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Background | Folic/folinic acid | Unknown | — | Oral |
| Background | Methotrexate | Small molecule | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |