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

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Uveitis

Treatments: Biological: Placebo; Biological: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103024

CAIN457C2302E1

2009-015509-38 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

AIN457 300mg s.c every 2 weeks

Experimental group

Treatment:

Biological: AIN457

Biological: AIN457

Biological: AIN457

AIN457 300mg s.c every 4 weeks

Experimental group

Treatment:

Biological: AIN457

Biological: AIN457

Biological: AIN457

AIN457 150mg s.c every 4 weeks

Experimental group

Treatment:

Biological: AIN457

Biological: AIN457

Biological: AIN457

Placebo s.c every 2 weeks

Placebo Comparator group

Treatment:

Biological: Placebo