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Withdrawn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