Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

Non-infectious Uveitis Clinical Trial

— ENDURE  

Official title:

A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01090310
• Other study ID #: CAIN457C2301E1
• Secondary ID: 2009-015508-24
• Status: Terminated
• Phase: Phase 3
• First received: March 18, 2010
• Last updated: December 8, 2015
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSwitzerland: SwissmedicGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of MedicinesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: National Health Surveillance AgencyIndia: Ministry of HealthIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have completed the entire treatment period of the 24 week core study

Exclusion Criteria:

• Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Uveitis

Intervention

Drug:
• AIN457
AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
• Placebo
Matching placebo to AIN457

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Tübingen
India	Novartis Investigative Site	New Delhi
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel-Aviv
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Lausanne	CHE
Switzerland	Novartis Investigative Site	Luzern
Switzerland	Novartis Investigative Site	St. Gallen
Switzerland	Novartis Investigative Site	Zuerich
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	York
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Cambridge	Massachusetts
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  Germany,  India,  Israel,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline	Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: = 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension	Baseline to 52 weeks	No
Secondary	Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value	The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks	Baseline to 52 weeks	No
Secondary	Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension	The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score	Baseline to 52 weeks	No
Secondary	Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies	Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4	Baseline to 52 weeks	No
Secondary	Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension	IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.	Baseline to 52 weeks	No