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Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

NCT01900431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-06-20

Study results available
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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).

Conditions

  • Uveitis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-07-31
Completion
2016-04-30

Countries

  • United States
  • Czechia
  • France
  • Italy
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900431 on ClinicalTrials.gov