NCT01900431

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The total duration per participant was up to 58 weeks, which included a 2 week screening period, 16 weeks principal treatment period (Part A), 34 weeks extension treatment period (Part B) or open label treatment period (Part C), and 6 weeks after last treatment administration. Participants with decrease in vitreous haze (VH) ≥2; or corticosteroids dose \<10 mg/day at Week 16 were considered as responders. Participants who did not complete the principal treatment period (Part A) due to lack of efficacy; or no decrease in VH ≥2 and corticosteroids dose ≥10 mg/day at Week 16; or no decrease in VH ≥2 and corticosteroids dose missing at Week 16; or non-responder according to medical review, were considered as non-responders. Responder participants, observed at Week 16 (at the end of Part A), were invited to continue in the extension treatment period (Part B). Non-responder participants, observed within the first 16 weeks, were offered to be treated by open-label sarilumab (Part C).

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
DRUG	Prednisone	Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
DRUG	Methotrexate	Pharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular
DRUG	Folic/folinic acid	Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
OTHER	Placebo (for Sarilumab)	Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2016-04-01
• First posted: 2013-07-16
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

20 sites across 6 countries: United States, Czechia, France, Italy, Spain, Turkey (Türkiye)