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

Phase 3

Withdrawn

• Conditions: Uveitis
• Interventions: Biological: AIN457; Biological: Placebo

• Registration Number: NCT01103024
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Start: 2010-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIN457 300mg s.c every 2 weeks	AIN457	-
AIN457 300mg s.c every 4 weeks	AIN457	-
AIN457 150mg s.c every 4 weeks	AIN457	-
Placebo s.c every 2 weeks	Placebo	-

Primary Outcome Measures

Name	Time	Method
Rate of recurrence	baseline to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change in immunosuppressive medication score from core study baseline	baseline to 52 weeks
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks	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

Trial Locations

Locations (3)

Novartis Investigative Site; 🇨🇭 Bern, Switzerland

Novartis Investigational Site; 🇯🇵 Kyoto, Japan

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States