Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (INSURE)

A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior, or Panuveitis Requiring Immunosuppression (INSURE Study)

The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.

Study Overview

• Status: Withdrawn
• Conditions: Uveitis
• Intervention / Treatment: Biological: Placebo; Biological: AIN457

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Novartis Investigative Site
    • North York, Ontario, Canada
      • Novartis Investigative Site
• Israel
  • Ramat Gan, Israel, 52621
    • Novartis Investigative Site
• Japan
  • Bunkyo-ku, Japan
    • Novartis Investigative Site
  • Fukuoka, Japan
    • Novartis Investigative Site
  • Fukushima, Japan
    • Novartis Investigative Site
  • Kyoto, Japan, 602-0841
    • Novartis Investigational site
  • Sapporo, Japan
    • Novartis Investigative Site
  • Tochigi, Japan
    • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland
    • Novartis Investigative Site
• United States
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have completed the entire treatment period of the 28-week core study
• Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension 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 would preclude the participant from adhering to the protocol or completing the study per protocol
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
• Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS
• They are using simultaneously double barrier or two acceptable methods of contraception
• They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing
• They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing
• Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
• Partners have been sterilized by vasectomy or other reliable means

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIN457 300mg s.c every 2 weeks	Biological: AIN457
Experimental: AIN457 300mg s.c every 4 weeks	Biological: AIN457
Experimental: AIN457 150mg s.c every 4 weeks	Biological: AIN457
Placebo Comparator: Placebo s.c every 2 weeks	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of recurrence	baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in immunosuppressive medication score from core study baseline	baseline to 52 weeks
Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication	baseline to 52 weeks
Mean change in best corrected visual acuity from baseline	baseline to 52 weeks
Change from baseline in Quality of Life/Patient reported outcome assessments	baseline to 52 weeks
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks	baseline to 52 weeks

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: uveitis; intermediate uveitis; panuveitis; posterior uveitis; Active uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457C2302E1; 2009-015509-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No