Conditions: Non-infectious Uveitis
Keywords: Uveitis eye IL-17 IL-17A IL17 AIN457 Vogt-Koyanagi-Harada Behcet's Behcet Sympathetic ophthalmia Multifocal choroiditis Birdshot HLA-B27 Birdshot retinochoroiditis Retinal vasculitis Sarcoidosis Intermediate uveitis Panuveitis Posterior uveitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22. arm 2: 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. arm 3: Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. arm 4: 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. arm 5: 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. arm 6: Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). arm 7: Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). arm 8: 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.

Interventions: intervention 1: AIN457 intervention 2: AIN 457 intervention 3: AIN457
Intervention descriptions: intervention 1: AIN457 subcutaneous dose intervention 2: AIN457 low dose (i.v) intervention 3: AIN457 high dose (i.v)

Protocol document: