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

Uveitis Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01103024
• Other study ID #: CAIN457C2302E1
• Secondary ID: 2009-015509-38
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: February 2011

Study information

• Verified date: September 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Intervention

Biological:
• AIN457

• AIN457

• AIN457

• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	North York	Ontario
Israel	Novartis Investigative Site	Ramat Gan
Japan	Novartis Investigative Site	Bunkyo-ku
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukushima
Japan	Novartis Investigational Site	Kyoto
Japan	Novartis Investigative Site	Sapporo
Japan	Novartis Investigative Site	Tochigi
Switzerland	Novartis Investigative Site	Bern
United States	Texas Retina Associates	Arlington	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Japan,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence		baseline to 52 weeks
Secondary	Change in immunosuppressive medication score from core study baseline		baseline to 52 weeks
Secondary	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
Secondary	Mean change in best corrected visual acuity from baseline		baseline to 52 weeks
Secondary	Change from baseline in Quality of Life/Patient reported outcome assessments		baseline to 52 weeks
Secondary	Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks		baseline to 52 weeks

External Links

•   Core and extension results on Novartis Clinical Trial Results Database