The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients

Part of paid clinical trials in Andover, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01250171
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 10 mg/kg — BIOLOGICAL
    Secukinumab was prepared in a sterile water solution.
  • Canakinumab 10 mg/kg — BIOLOGICAL
    Canakinumab was prepared in a sterile water solution.
  • Placebo — BIOLOGICAL
    The placebo solution for infusion contained 5% glucose.

Study Details

This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.

Key Dates

Start date
Nov 30, 2010
Status verified
Dec 2012
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 10 mg/kg
    Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
  • Experimental: Canakinumab 10 mg/kg
    Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
  • Placebo Comparator: Placebo
    Patients received a single placebo infusion intravenously over a 2 hour period.

Primary Outcome Measure

Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4 [ Time Frame: Baseline to Week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ora Inc, 300 Brickstone Square,AndoverMassachusetts01810-

Find similar trials in Andover, MA

By research site
Ora Inc, 300 Brickstone Square· Andover, MA

Related Studies