Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis

A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327664

Acronym

SUPPORT

Enrollment

Registered

2011-04-01

Start date

2011-03-31

Completion date

Unknown

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis

Keywords

Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis

Brief summary

This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.

Interventions

BIOLOGICALAIN457

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 any study assessment is performed * Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1) * Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator

Exclusion criteria

* Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457 * Pregnant or nursing (lactating) women * Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Participants with adverse events as a measure of safety and tolerability	up to 36 months
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis	up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis	up to 36 months

Secondary

Measure	Time frame
Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment	up to 36 months
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment	up to 36 months
Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457	up to 36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026