Safety and Efficacy of AIN457 in Noninfectious Uveitis

Novartis

Status and phase: Completed; Phase 2

Conditions: Non-infectious Uveitis

Treatments: Drug: AIN 457; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00685399

CAIN457A2208

2011-001243-67 (EudraCT Number)

Details and patient eligibility

About

This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active uveitis (i.e., uveitis that is not in remission).
• Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.

Exclusion criteria

• Active infection.
• Weight must not be greater that 120kg.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 8 patient groups

Cohort 1

Experimental group

Description:

Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.

Treatment:

Drug: AIN457

Drug: AIN457

Cohort 2

Experimental group

Description:

Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.

Treatment:

Drug: AIN457

Drug: AIN457

Cohort 3

Experimental group

Description:

Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.

Treatment:

Drug: AIN 457

Cohort 4

Experimental group

Description:

Extension period: Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.

Treatment:

Drug: AIN 457

Cohort 5

Experimental group

Description:

Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.

Treatment:

Drug: AIN457

Drug: AIN457

Cohort 6 Arm 1

Experimental group

Description:

Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).

Treatment:

Drug: AIN457

Drug: AIN457

Cohort 6 Arm 2

Experimental group

Description:

Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).

Treatment:

Drug: AIN 457

Cohort 6 Arm 3

Experimental group

Description:

Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.

Treatment:

Drug: AIN457

Drug: AIN457