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

Sponsor

Novartis (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01103024

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis	Biological: AIN457 Biological: AIN457 Biological: AIN457 Biological: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Rate of recurrence [baseline to 52 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Retina Associates	Arlington	Texas	United States	76012
2	Novartis Investigative Site	London	Ontario	Canada
3	Novartis Investigative Site	North York	Ontario	Canada
4	Novartis Investigative Site	Ramat Gan		Israel	52621
5	Novartis Investigative Site	Bunkyo-ku		Japan
6	Novartis Investigative Site	Fukuoka		Japan
7	Novartis Investigative Site	Fukushima		Japan
8	Novartis Investigational Site	Kyoto		Japan	602-0841
9	Novartis Investigative Site	Sapporo		Japan
10	Novartis Investigative Site	Tochigi		Japan
11	Novartis Investigative Site	Bern		Switzerland