CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Secukinumab 10 mg/kg +2 morebiological
Likely dose
Secukinumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01250171
NCT01250171Phase 2Completed
CompareCT.gov

A Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Intravenous Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Syndrome

Novartis Pharmaceuticals·interventional·Posted Nov 30, 2010·Updated Jan 7, 2013

In Brief

A Phase 2 clinical trial evaluating Secukinumab 10 mg/kg, Canakinumab 10 mg/kg, and 1 other intervention for Dry Eye. Completed, enrolled 72 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.6 years ago

Interventions

Secukinumab 10 mg/kgbiological

Secukinumab was prepared in a sterile water solution.

Canakinumab 10 mg/kgbiological

Canakinumab was prepared in a sterile water solution.

Placebobiological

The placebo solution for infusion contained 5% glucose.