Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis (ENDURE)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Non-infectious Uveitis

Treatments: Drug: Placebo; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090310

2009-015508-24

CAIN457C2301E1

Details and patient eligibility

About

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed the entire treatment period of the 24 week core 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 wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

86 participants in 4 patient groups, including a placebo group

AIN457 300mg every 2 weeks

Experimental group

Description:

AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks

Treatment:

Drug: AIN457

AIN457 300 mg every 4 weeks

Experimental group

Description:

AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Treatment:

Drug: AIN457

AIN457 150 mg every 4 weeks

Experimental group

Description:

AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Treatment:

Drug: AIN457

Placebo

Placebo Comparator group

Description:

Placebo s.c. every 2 weeks

Treatment:

Drug: Placebo