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

Primary Purpose

Uveitis

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AIN457
AIN457
AIN457
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Retina Associates
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AIN457 300mg s.c every 2 weeks

AIN457 300mg s.c every 4 weeks

AIN457 150mg s.c every 4 weeks

Placebo s.c every 2 weeks

Arm Description

Outcomes

Primary Outcome Measures

Rate of recurrence

Secondary Outcome Measures

Change in immunosuppressive medication score from core study baseline
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
Mean change in best corrected visual acuity from baseline
Change from baseline in Quality of Life/Patient reported outcome assessments
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks

Full Information

First Posted
April 9, 2010
Last Updated
September 24, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01103024
Brief Title
Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
Acronym
INSURE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Core study in non-infectious active uveitis was terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457 300mg s.c every 2 weeks
Arm Type
Experimental
Arm Title
AIN457 300mg s.c every 4 weeks
Arm Type
Experimental
Arm Title
AIN457 150mg s.c every 4 weeks
Arm Type
Experimental
Arm Title
Placebo s.c every 2 weeks
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AIN457
Intervention Type
Biological
Intervention Name(s)
AIN457
Intervention Type
Biological
Intervention Name(s)
AIN457
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Rate of recurrence
Time Frame
baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Change in immunosuppressive medication score from core study baseline
Time Frame
baseline to 52 weeks
Title
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
Time Frame
baseline to 52 weeks
Title
Mean change in best corrected visual acuity from baseline
Time Frame
baseline to 52 weeks
Title
Change from baseline in Quality of Life/Patient reported outcome assessments
Time Frame
baseline to 52 weeks
Title
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks
Time Frame
baseline to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
North York
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukushima
Country
Japan
Facility Name
Novartis Investigational Site
City
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
Country
Japan
Facility Name
Novartis Investigative Site
City
Tochigi
Country
Japan
Facility Name
Novartis Investigative Site
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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

Learn more about this trial

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

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